51. 全身性強皮症
[臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210

Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
189 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04432545
(ClinicalTrials.gov)
September 1, 202210/6/2020Infusion of Allogeneic Mesenchymal Stem Cells in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary InvolvementInfusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement to TreatmentSystemic Sclerosis Pulmonary;Pulmonary Hypertension;Pulmonary FibrosisBiological: Mesenchymal Stem Cells from Wharton ´s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ´s jellyUniversidad de la SabanaFundación Neumologica Colombiana;Stem Medicina Regenerativa;CryoHoldco LATAMAvailable18 Years65 YearsAllColombia
2NCT03800017
(ClinicalTrials.gov)
September 1, 202121/11/2018Skeletal Muscle Function in Interstitial Lung DiseaseInvestigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung DiseaseInterstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Hypersensitivity Pneumonitis;Scleroderma;Nonspecific Interstitial PneumoniaBiological: HyperoxiaUniversity of British ColumbiaNULLNot yet recruiting40 Years80 YearsAll40N/ANULL
3NCT04647890
(ClinicalTrials.gov)
February 202116/11/2020Effects of FT011 in Systemic SclerosisA Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic SclerosisScleroderma, Systemic;Scleroderma, Diffuse;Sclerosis, SystemicDrug: FT011;Drug: PlaceboCerta TherapeuticsNULLNot yet recruiting18 Years75 YearsAll30Phase 2NULL
4NCT04515706
(ClinicalTrials.gov)
January 1, 202113/8/2020Iguratimod in Systemic SclerosisSafety, Tolerability, Efficacy of Iguratimod in Systemic SclerosisSystemic Sclerosis, DiffuseDrug: Iguratimod;Drug: PlaceboRenJi HospitalNULLNot yet recruiting19 Years74 YearsAll20N/ANULL
5NCT04627857
(ClinicalTrials.gov)
January 1, 20216/11/2020Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic SclerosisEffect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic SclerosisScleroderma SystemicDevice: Manual toothbrush;Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss);Device: Sonic toothbrush;Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)University Hospital, Strasbourg, FranceNULLNot yet recruiting18 YearsN/AAll100N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04440592
(ClinicalTrials.gov)
December 31, 202017/6/2020Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: MT-7117;Drug: PlaceboMitsubishi Tanabe Pharma Development America, Inc.NULLRecruiting18 Years75 YearsAll72Phase 2United States
7NCT04656704
(ClinicalTrials.gov)
December 1, 202030/11/2020Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin DiseaseInvestigating Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin DiseaseMicrostomia;Scleroderma;CREST Syndrome;Scleromyxedema;MorpheaDrug: hyaluronidase injected intradermallyBrigham and Women's HospitalNULLNot yet recruiting18 YearsN/AAll8Early Phase 1NULL
8NCT04303208
(ClinicalTrials.gov)
December 20203/3/2020Plasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic SclerosisPlasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic SclerosisSystemic SclerosisProcedure: 2 ml of whole blood sample will be collected on EDTA tubeAssiut UniversityNULLNot yet recruiting18 YearsN/AAll80N/ANULL
9NCT04478994
(ClinicalTrials.gov)
November 202016/7/2020A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisBiological: TEPEZZA;Other: PlaceboHorizon Therapeutics USA, Inc.NULLRecruiting18 Years80 YearsAll25Phase 1United States
10NCT04356287
(ClinicalTrials.gov)
October 202015/4/2020Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic SclerosisPhase I/II Randomized Controlled Trial of Umbilical Cord-derived mesenChymAl stRomal cElls in Systemic SclerosisSclerosis, Systemic;Mesenchymal Stem CellsBiological: UCMSC;Other: PlaceboMarie Hudson, MDAssistance Publique - Hôpitaux de Paris;University Paris 7 - Denis Diderot;Université de Montréal;Medical University of South Carolina;Centre hospitalier de l'Université de Montréal (CHUM);McGill University Health Centre/Research Institute of the McGill University Health CentreNot yet recruiting18 YearsN/AAll18Phase 1;Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04300426
(ClinicalTrials.gov)
September 24, 202025/2/2020Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)Aiming to Reduce Disease-related Gastrointestinal Symptoms in Systemic Sclerosis by Repeat Intestinal Infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Randomized, Double-blind Placebo-controlled 20 Week StudySystemic SclerosisDrug: ACHIM as solute (10^9 intestinal microbes/ml)Oslo University HospitalSouth-Eastern Norway Regional Health Authority;Haukeland University Hospital;St. Olavs Hospital;University Hospital of North NorwayRecruiting18 Years85 YearsAll70Phase 2Norway
12NCT04356755
(ClinicalTrials.gov)
September 22, 202011/3/2020Subcutaneous Injections of Autologous ASC to Heal Digital Ulcers in Patients With Scleroderma.Subcutaneous Injections of Autologous Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With SclerodermaSystemic SclerosisProcedure: Adipose tissue harvest;Drug: Autologous ASC;Drug: PlaceboUniversity Hospital, ToulouseNULLRecruiting18 YearsN/AAll32Phase 2France
13NCT04380831
(ClinicalTrials.gov)
September 22, 202030/4/2020TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic SclerosisPilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic SclerosisSystemic SclerodermaProcedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Radiation: Intensity-Modulated Radiation Therapy;Procedure: Total-Body IrradiationCity of Hope Medical CenterNational Cancer Institute (NCI)Recruiting18 Years65 YearsAll15Early Phase 1United States
14NCT04166552
(ClinicalTrials.gov)
June 11, 20206/11/2019Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic SclerosisA Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Patients will be randomized to receive EHP-101 or PlaceboEmerald Health Pharmaceuticals Inc.Iqvia Pty LtdRecruiting18 Years70 YearsAll36Phase 2United States;Australia;New Zealand
15NCT04265144
(ClinicalTrials.gov)
June 8, 20205/2/2020Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference CentreCohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune DiseasesScleroderma;Systemic SclerosisBiological: Blood samples;Other: Biopsy;Other: Bronchoalveolar samplesUniversity Hospital, BordeauxNULLRecruiting18 YearsN/AAll500N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04244916
(ClinicalTrials.gov)
May 25, 20206/1/2020MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic SclerosisProspective Study to Investigate the Relevance of Monitoring Area Under the Curve of Mycophenolic Acid in Patients Receiving Mycophenolate Mofetil to Treat a Diffuse Cutaneous or a Pulmonary Involvement of Systemic SclerosisSystemic SclerosisBiological: AUC of MPA measureAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll50France
17NCT04200755
(ClinicalTrials.gov)
May 19, 202010/12/2019Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized SclerodermaA Randomized, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Dupilumab in Localized SclerodermaLocalized SclerodermaDrug: Dupilumab 300Mg Solution for Injection;Other: PlaceboUniversity of CologneNULLRecruiting18 YearsN/AAll45Phase 2Germany
18NCT04523506
(ClinicalTrials.gov)
May 8, 202019/7/2020The Effects of Botulinum Toxin on Oral Aperture in Patients With SclerodermaThe Effects of Botulinum Toxin on Oral Aperture in Patients With SclerodermaSclerodermaBiological: Botulinum toxin(Botox)University of Texas Southwestern Medical CenterNULLRecruiting18 Years65 YearsAll30Early Phase 1United States
19NCT04325217
(ClinicalTrials.gov)
April 15, 202026/3/2020Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in JapanPost-Marketing Surveillance (PMS) of Nintedanib (Ofev Capsule) in Systemic Scleroderma With Interstitial Lung Disease (SSc-ILD) in JapanLung Diseases, InterstitialDrug: NintedanibBoehringer IngelheimNULLRecruitingN/AN/AAll600Japan
20NCT03582800
(ClinicalTrials.gov)
January 6, 202013/6/2018Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot StudySubcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot StudySystemic Sclerosis;Dermatomyositis;iPPSD2Drug: STSUniversity Hospital, LimogesNULLRecruiting6 MonthsN/AAll40Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04388176
(ClinicalTrials.gov)
January 3, 202011/5/2020Cold Challenge With C21 in RPA Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)Raynaud Phenomenon;Systemic SclerosisDrug: C21;Drug: PlaceboVicore Pharma ABSGS Life Sciences, a division of SGS Belgium NVRecruiting19 Years75 YearsAll16Phase 2United Kingdom
22NCT04138485
(ClinicalTrials.gov)
December 20, 201914/10/2019Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic SclerosisDiffuse Cutaneous Systemic SclerosisBiological: IgPro10;Biological: PlaceboCSL BehringNULLWithdrawn18 YearsN/AAll0Phase 2United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom
23NCT03740724
(ClinicalTrials.gov)
December 18, 20196/11/2018A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Autologous Human Dermal Fibroblasts) Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)Morphea;Scleroderma, Localized;SclerodermaGenetic: FCX-013;Drug: veledimexFibrocell Technologies, Inc.NULLRecruiting18 YearsN/AAll10Phase 1;Phase 2United States
24NCT04095351
(ClinicalTrials.gov)
December 9, 201913/9/2019Connective Tissue Diseases and Lung ManifestationsConnective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)Connective Tissue Diseases;Interstitial Lung Disease;Systemic SclerosisDiagnostic Test: Pulmonary function test;Diagnostic Test: Imaging;Biological: Blood samplingMedical University InnsbruckBoehringer IngelheimRecruiting18 Years80 YearsAll120Austria
25NCT04040322
(ClinicalTrials.gov)
October 14, 201930/7/2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)Raynaud's Phenomenon Secondary to Systemic SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.NULLRecruiting18 YearsN/AAll180Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04137224
(ClinicalTrials.gov)
September 19, 201921/10/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc)Diffuse Cutaneous Systemic SclerosisBiological: IgPro20;Biological: IgPro10CSL BehringNULLRecruiting18 YearsN/AAll26Phase 2Australia;France;Germany;Italy;Poland;United Kingdom
27NCT03844061
(ClinicalTrials.gov)
July 29, 201931/1/2019Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisA Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMFHospital for Special Surgery, New YorkGlaxoSmithKlineRecruiting18 Years80 YearsAll30Phase 2United States
28NCT04045743
(ClinicalTrials.gov)
July 19, 201927/7/2019The Benefit of Bermekimab in Patients With Systemic SclerosisClinical Efficacy of Inhibition of Organ Dysfunction Through Bermekimab in Systemic Sclerosis: A Proof- Of-Concept Double-Blind Randomized Clinical Trial (the Light Trial)Scleroderma, SystemicDrug: MABp1 (Bermekimab) OR Placebo;Drug: MABp1 (Bermekimab)Hellenic Institute for the Study of SepsisNULLRecruiting18 YearsN/AAll20Phase 2Greece
29NCT03976648
(ClinicalTrials.gov)
July 18, 20194/6/2019A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic SclerosisA Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic SclerosisSclerosis, SystemicDrug: GLPG1690Galapagos NVNULLActive, not recruiting18 YearsN/AAll31Phase 2United States;Belgium;Italy;Spain;United Kingdom
30NCT03919799
(ClinicalTrials.gov)
July 9, 201921/11/2018KD025 in Subjects With Diffuse Cutaneous Systemic SclerosisA Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic SclerosisSystem; Sclerosis;Diffuse Cutaneous Systemic SclerosisDrug: Belumosudil (KD025);Drug: PlaceboKadmon Corporation, LLCNULLRecruiting18 Years100 YearsAll60Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04036227
(ClinicalTrials.gov)
July 3, 201923/7/2019Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)HealthyDrug: GS-248;Drug: PlaceboGesynta Pharma ABCTC Clinical Trial ConsultantsCompleted18 Years75 YearsAll72Phase 1Sweden
32NCT03957681
(ClinicalTrials.gov)
May 23, 201916/5/2019A Phase 3 Study of KHK4827 in Patients With Systemic SclerosisA Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin ThickeningModerate to Severe Systemic SclerosisDrug: KHK4827;Drug: PlaceboKyowa Kirin Co., Ltd.NULLActive, not recruiting18 Years70 YearsAll100Phase 3Japan
33NCT03198689
(ClinicalTrials.gov)
May 7, 201914/6/2017Brentuximab Vedotin in Early Diffuse Cutaneous Systemic SclerosisA Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)Diffuse Cutaneous Systemic SclerosisDrug: Brentuximab VedotinLawson Health Research InstituteSeagen Inc.Recruiting18 YearsN/AAll10Phase 2Canada
34NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll264Phase 1United States
35NCT03867097
(ClinicalTrials.gov)
March 4, 20196/3/2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.NULLCompleted18 YearsN/AAll41Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03798366
(ClinicalTrials.gov)
January 14, 20193/1/2019A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic SclerosisA Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic SclerosisSclerodermaDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLCompleted18 YearsN/AAll33Phase 2United States;Belgium;Germany;Italy;Spain;United Kingdom
37NCT03831438
(ClinicalTrials.gov)
January 1, 201931/1/2019Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic SclerosisA Phase 1 Open-Label Study to Determine the Safety and Tolerability of AVID200: A Transforming Growth Factor ß (TGFß) Inhibitor, in Patients With Diffuse Cutaneous Systemic SclerosisScleroderma, DiffuseDrug: AVID200Formation BiologicsNULLActive, not recruiting18 YearsN/AAll24Phase 1United States
38NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain
39EUCTR2018-001719-65-NL
(EUCTR)
10/12/201809/07/2018 CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study - CALC-SSc study Systemic sclerosis (SSc) is a rare progressive autoimmune disease hallmarked by severe vasculopathy. Patients are prone to enhanced calcification of skin and the vasculature. Active calcifications may not only occur in the skin of patients with clinically overt calcinosis cutis, but also in SSc patients without. Since calcification is strongly associated with local inflammation, it may very well occur in internal organs and serve as an early proxy for long-term SSc-related complications.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]University Medial Center GroningenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 4Netherlands
40NCT03742466
(ClinicalTrials.gov)
November 10, 201810/11/2018Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma PatientsLocal Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical TrialCarpal Tunnel Syndrome;Chronic Pain;SclerodermaDrug: Ozone;Drug: methylprednisolone acetateAssiut UniversityNULLCompleted20 Years60 YearsAll50N/AEgypt
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03211793
(ClinicalTrials.gov)
November 201827/4/2017Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic SclerosisMesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS TrialSystemic Sclerosis;Digital UlcerDrug: Mesenchymal stromal cells;Other: PlaceboUMC UtrechtZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknown status18 YearsN/AAll20Phase 1;Phase 2Netherlands
42NCT03717961
(ClinicalTrials.gov)
October 15, 201815/10/2018Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic SclerosisMulticenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Study to Assess Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: BOTOX® solution;Drug: Placebo groupAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll91Phase 3France
43NCT03575156
(ClinicalTrials.gov)
September 20, 20187/6/2018Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisMicroparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisSystemic Lupus Erythematosus;Systemic SclerodermaBiological: blood sample;Biological: urine sampleUniversity Hospital, BordeauxNULLActive, not recruiting18 YearsN/AAll208N/AFrance
44NCT03678987
(ClinicalTrials.gov)
September 13, 201813/9/2018Mycophenolate Mofetil Pharmacokinetics in Systemic SclerosisMycophenolate Mofetil in Systemic Sclerosis: A Phase 1 Pharmacokinetic Study of Orally Ingested Mycophenolate Mofetil Tablets in Patients Suffering From Systemic SclerosisSystemic Sclerosis;Gastrointestinal ComplicationDiagnostic Test: P-MPA concentration;Drug: mycophenolic acidRegion SkaneNULLCompleted18 YearsN/AAll35Phase 1Sweden
45NCT03726398
(ClinicalTrials.gov)
September 1, 201821/10/2018CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PHCompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated Interstitial Lung DiseasE and Pulmonary Hypertension (PH): The CRuSADE PH StudyInterstitial Lung Disease;Scleroderma;Pulmonary HypertensionDrug: Opsumit 10 Mg TabletFranz Rischard, DONational Jewish Health;University of PittsburghRecruiting18 YearsN/AAll26Phase 2;Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03629002
(ClinicalTrials.gov)
September 20187/8/2018BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIABIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HANDSystemic SclerodermaBiological: Study of the gene expression profileAssistance Publique Hopitaux De MarseilleNULLUnknown status18 YearsN/AAll30France
47NCT03558854
(ClinicalTrials.gov)
August 28, 20183/5/2018Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma PatientsEvaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic SclerosisSystemic SclerosisDrug: Acetylsalicylic acid;Drug: Placebo oral capsuleFederal University of São PauloNULLRecruiting18 Years65 YearsAll70Phase 4Brazil
48NCT03630211
(ClinicalTrials.gov)
July 31, 20187/8/2018Autologous Stem Cell Transplantation in Patients With Systemic SclerosisAutologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary HypertensionDrug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body IrradiationPaul SzabolcsNULLRecruiting16 Years70 YearsAll8Phase 2United States
49NCT03856853
(ClinicalTrials.gov)
June 15, 201826/2/2019Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung DiseaseA Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)Drug: Pirfenidone;Other: placeboBeijing Continent Pharmaceutical Co, Ltd.Shanghai Genomics, Inc.;GNI-EPS Pharmaceuticals, Inc. (GNI Group)Recruiting18 Years75 YearsAll144Phase 3China
50NCT03644225
(ClinicalTrials.gov)
June 11, 20184/5/2018Suction Based Characterization of Healthy and Diseased SkinMechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin DeformabilitySystemic SclerosisDevice: Measurment with Aspirational Medical Device;Device: Measurment with Cutometer MPA 580Oliver DistlerSwiss Federal Institute of TechnologyCompleted18 YearsN/AAll67N/ASwitzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03365869
(ClinicalTrials.gov)
June 1, 20184/12/2017A Pilot-Study of Sirolimus for the Treatment of Systemic SclerosisA Phase ? Pilot-Study With Sirolimus for the Treatment of Systemic SclerosisSystemic SclerosisDrug: SirolimusPeking University People's HospitalNULLNot yet recruiting18 Years80 YearsAll72Phase 2NULL
52NCT03593902
(ClinicalTrials.gov)
May 17, 201828/6/2018Cardiac Safe Transplants for Systemic SclerosisAutologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac DysfunctionSystemic Sclerosis;SclerodermaDrug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years65 YearsAll9Phase 2;Phase 3United States
53NCT03508375
(ClinicalTrials.gov)
May 15, 201816/4/2018Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic SclerosisEvaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic SclerosisSystemic SclerodermaBiological: blood samplesAssistance Publique Hopitaux De MarseilleNULLRecruiting18 YearsN/AAll75N/AFrance
54NCT03607071
(ClinicalTrials.gov)
May 15, 201820/7/2018Outcome of Steroid Therapy for Myocardial Inflammation in SclerodermaOutcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label StudyMyocardial InflammationDrug: Prednisolone and taperKhon Kaen UniversityNULLCompleted18 YearsN/AAll20Phase 2Thailand
55NCT03430388
(ClinicalTrials.gov)
January 31, 201830/1/2018Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNULLCompleted2 Years60 YearsAll600N/ABrazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03708718
(ClinicalTrials.gov)
December 21, 20178/10/2018Prednisolone in Early Diffuse Systemic SclerosisA Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)Systemic SclerosisDrug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'Prof. Ariane herrickVersus ArthritisRecruiting18 YearsN/AAll72Phase 2United Kingdom
57NCT03398837
(ClinicalTrials.gov)
December 18, 20175/1/2018Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsuleCorbus Pharmaceuticals Inc.NULLActive, not recruiting18 YearsN/AAll365Phase 3United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom
58NCT04274257
(ClinicalTrials.gov)
December 4, 201713/2/2020A Study of the Efficacy and Safety of Rituximab in Participants With Systemic SclerosisDouble-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic SclerosisScleroderma, Systemic;Skin Sclerosis;Lung Fibrosis;Autoimmune Diseases;Collagen DiseasesDrug: Double-Blind Placebo;Drug: Double-Blind RituximabTokyo UniversityJapan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.Completed20 Years80 YearsAll56Phase 2;Phase 3Japan
59NCT03221257
(ClinicalTrials.gov)
November 28, 201712/7/2017Scleroderma Lung Study III - Combining Pirfenidone With MycophenolateScleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung DiseaseScleroderma, Systemic;Interstitial Lung DiseaseDrug: Pirfenidone (PFD);Drug: Placebo (Plac);Drug: Mycophenolate Mofetil (MMF)Michael RothUniversity of Michigan;Genentech, Inc.;University of California, Los AngelesActive, not recruiting18 YearsN/AAll150Phase 2United States
60NCT03313180
(ClinicalTrials.gov)
November 27, 201713/10/2017A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis.An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)Lung Diseases, InterstitialDrug: NintedanibBoehringer IngelheimNULLActive, not recruiting18 YearsN/AAll444Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;India;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT04368403
(ClinicalTrials.gov)
October 6, 201713/4/2020A Study of KHK4827 in Patients With Systemic SclerosisA Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic SclerosisSystemic SclerosisDrug: KHK4827Kyowa Kirin Co., Ltd.NULLActive, not recruiting18 Years70 YearsAll8Phase 1Japan
62NCT03274076
(ClinicalTrials.gov)
September 25, 201728/8/2017Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability StudySystemic Sclerosis;SclerodermaDrug: Tofacitinib;Drug: Placebo Oral TabletUniversity of MichiganPfizerCompleted18 Years70 YearsAll15Phase 1;Phase 2United States
63NCT03222492
(ClinicalTrials.gov)
September 20, 201717/7/2017Brentuximab Vedotin for Systemic SclerosisEvaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)Diffuse Cutaneous Systemic Sclerosis;Scleroderma;dcSScBiological: Brentuximab Vedotin;Biological: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Seagen Inc.Recruiting18 Years70 YearsAll24Phase 1;Phase 2United States;Canada
64EUCTR2015-001617-27-BG
(EUCTR)
02/08/201717/05/2017A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
65NCT03120533
(ClinicalTrials.gov)
June 20, 201723/3/2017Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept StudyTherapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept StudyScleroderma, SystemicDrug: Iontophoresis of treprostinil;Drug: Iontophoresis of placeboUniversity Hospital, GrenobleLinksium;University Grenoble AlpsCompleted18 YearsN/AAll18Phase 1;Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03041025
(ClinicalTrials.gov)
June 5, 201731/1/2017Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic SclerosisA Multi-center, Randomized, Double-blind (Sponsor Open), Placebo-controlled, Repeat-dose, Proof of Mechanism Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Explore Efficacy of GSK2330811 in Participants With Diffuse Cutaneous Systemic SclerosisScleroderma, SystemicDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll35Phase 2United States;Canada;Netherlands;United Kingdom
67NCT03155464
(ClinicalTrials.gov)
June 1, 201724/4/2017Intraoperative ICG for Systemic SclerosisA Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic ScerlosisSystemic SclerosisProcedure: Order of two elements of surgical procedure;Drug: Indocyanine GreenDuke UniversityNULLWithdrawn18 YearsN/AAll0Phase 4NULL
68EUCTR2015-001617-27-SI
(EUCTR)
26/05/201715/05/2017A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
69NCT03068234
(ClinicalTrials.gov)
May 201716/2/2017Pirfenidone as Treatment of Skin Fibrosis in Systemic SclerosisA Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic SclerosisSystemic SclerosisDrug: Pirfenidone;Drug: Placebo oral capsule;Drug: SteroidsRenJi HospitalNULLNot yet recruiting18 Years70 YearsAll72Phase 2;Phase 3China
70NCT03059979
(ClinicalTrials.gov)
January 201725/1/2017The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.Systemic Sclerosis;Raynaud PhenomenaDrug: Methylprednisolone;Other: sodium chlorideRadboud UniversityNULLRecruiting18 YearsN/AAll30Early Phase 1Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02682511
(ClinicalTrials.gov)
January 20178/2/2016Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionA Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune DiseasesDrug: Oral Ifetroban;Drug: Oral PlaceboCumberland PharmaceuticalsNULLRecruiting18 Years80 YearsAll34Phase 2United States;India
72NCT03007004
(ClinicalTrials.gov)
December 12, 201628/12/2016Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic SclerosisTrial to Confirm the Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic SclerosisSystemic Sclerosis Patients With Digital UlcersDrug: Botulinum toxin type B (2500 units / vial);Drug: Physiological salineGunma UniversityNULLCompleted18 YearsN/AAll10Phase 2Japan
73NCT02981082
(ClinicalTrials.gov)
December 201630/11/2016Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial HypertensionA Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.Systemic Sclerosis;Pulmonary; HypertensionDrug: Dimethyl Fumarate (DMF);Drug: Placebo Oral TabletRobert LafyatisBiogenTerminated18 Years80 YearsAll6Phase 1United States
74NCT03053739
(ClinicalTrials.gov)
December 201629/12/2016To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchNULLRecruiting18 YearsN/AAll50Phase 4India
75NCT02921971
(ClinicalTrials.gov)
November 23, 201630/9/2016Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept StudySystemic SclerosisDrug: SAR156597 (ACT14604);Drug: PlaceboSanofiNULLCompleted18 YearsN/AAll97Phase 2United States;Argentina;Belgium;Estonia;France;Germany;Italy;Mexico;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03388255
(ClinicalTrials.gov)
November 8, 201621/12/2017Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma DiseasesA Phase IV, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in Patients With Fibrotic and Atrophic Cutaneous Lesions in Scleroderma DiseasesScleroderma DiseaseDrug: PolydeoxyribonucleotidesMastelli S.r.lSintesi Research SrlActive, not recruiting18 YearsN/AAll25Phase 4Italy
77NCT02975960
(ClinicalTrials.gov)
October 25, 20169/11/2016ADMSCs for the Treatment of Systemic SclerosisAdipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic SclerosisSystemic SclerosisBiological: injection of autologous stromal vascular fractionThe Catholic University of KoreaSeoul St. Mary's HospitalCompleted18 YearsN/AAll7N/AKorea, Republic of
78NCT02896205
(ClinicalTrials.gov)
October 201627/8/2016Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung DiseaseA Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: PlaceboPostgraduate Institute of Medical Education and ResearchNULLCompleted18 YearsN/AAll41Phase 3India
79NCT02663895
(ClinicalTrials.gov)
October 201619/1/2016Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic SclerosisA Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic SclerosisSystemic Sclerosis;CalcinosisDrug: Oral treprostinilStanford UniversityUnited TherapeuticsCompleted18 YearsN/AAll12Phase 2United States
80NCT02798055
(ClinicalTrials.gov)
September 30, 20163/6/2016Bosentan Treatment of Digital Ulcers Related to Systemic SclerosisA National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment.Systematic Sclerosis;Digital Ulcer;SclerodermaDrug: Bosentan groupElpen Pharmaceutical Co. Inc.NULLCompleted18 Years80 YearsAll148Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT02915835
(ClinicalTrials.gov)
September 201615/9/2016Riociguat in Scleroderma Associated Digital UlcersA Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital UlcersScleroderma;Digital UlcersDrug: Riociguat;Drug: PlaceboDinesh Khanna, MD, MSBayerCompleted18 YearsN/AAll17Phase 2United States
82EUCTR2015-005023-11-PL
(EUCTR)
12/07/201620/06/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Spain;Poland;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
83EUCTR2015-005023-11-GB
(EUCTR)
08/07/201625/05/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
84EUCTR2015-005023-11-ES
(EUCTR)
04/07/201627/06/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 19.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
85EUCTR2015-001617-27-NL
(EUCTR)
07/06/201606/04/2016A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT02801305
(ClinicalTrials.gov)
June 20169/6/2016Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital UlcersAssessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers.Digital Ulcer of SclerodermaDrug: Diltiazem Gel 2%;Drug: Nitroglycerin Ointment 2%;Drug: VaselineMohammad Ali NazariniaShiraz University of Medical SciencesCompleted20 Years70 YearsAll90Phase 2Iran, Islamic Republic of
87NCT02733978
(ClinicalTrials.gov)
June 201625/3/2016Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic SclerosisNon-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic SclerosisUlcer;SclerodermaDevice: the ozone generator device (Human Pro medic, German)Assiut UniversityNULLCompletedN/AN/AAll50N/ANULL
88NCT02745145
(ClinicalTrials.gov)
May 31, 201615/4/2016Abituzumab in SSc-ILDA Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)Systemic Sclerosis-associated Interstitial Lung DiseaseDrug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years75 YearsAll24Phase 2United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey
89NCT02680717
(ClinicalTrials.gov)
March 20169/2/2016Comparative Effectiveness Trial in the Treatment of Pediatric Plaque MorpheaComparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque MorpheaSclerodermaDrug: Clobetasol;Drug: Calcipotriene;Drug: TacrolimusMedical College of WisconsinMayo Clinic;Seattle Children's Hospital;University of TorontoWithdrawn2 Years18 YearsAll0Phase 1NULL
90NCT02370693
(ClinicalTrials.gov)
March 201611/2/2015Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary FibrosisComparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis Grant Number: R34HL122558Interstitial Lung Disease;ILD;Systemic Sclerosis;SclerodermaDrug: Bortezomib;Drug: Placebo;Drug: Mycophenolate mofetilNorthwestern UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 YearsN/AAll30Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT02426229
(ClinicalTrials.gov)
February 20164/3/2015Safety & Suitability of Dabigatran to Inhibit Thrombin in SclerodermaSafety & Suitability of Dabigatran to Inhibit Thrombin in SclerodermaScleroderma;Interstitial Lung DiseaseDrug: dabigatran etexilateMedical University of South CarolinaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 Years70 YearsAll15Phase 1United States
92NCT02530996
(ClinicalTrials.gov)
January 1, 201629/7/2015Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and TreatmentSystemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and TreatmentRheumatologic DiseaseDrug: BH4;Other: Vasculopathy assessment;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years95 YearsAll32United States
93NCT03141125
(ClinicalTrials.gov)
January 201620/6/2016The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard TherapyThe Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy to Reduce Skin Fibrosis Based on Modified Rodnan Skin Score, Reduce Inflammation, Immunological Response and FibrosisSclerodermaOther: Physalis angulata ethanol extract;Other: PlaceboIndonesia UniversityNetherlands: Ministry of Health, Welfare and SportsCompleted18 Years60 YearsAll62N/AIndonesia
94NCT02453256
(ClinicalTrials.gov)
November 20, 201521/5/2015A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic SclerosisSystemic SclerosisDrug: Placebo;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll212Phase 3United States;Argentina;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Spain;Switzerland;United Kingdom;Brazil;Croatia;South Africa
95NCT02597933
(ClinicalTrials.gov)
November 12, 20158/10/2015A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung FibrosisA Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)Scleroderma, SystemicDrug: Nintedanib;Drug: PlaceboBoehringer IngelheimNULLCompleted18 YearsN/AAll580Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03531216
(ClinicalTrials.gov)
November 2, 20159/5/2018Topical Rosemary Oil Application in Systemic SclerosisPsychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized TrialSystemic SclerosisOther: Rosemary essential oil;Other: PlaceboARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity Hospital TuebingenCompleted18 YearsN/AAll12N/AGermany
97NCT02503644
(ClinicalTrials.gov)
October 29, 201530/6/2015Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic SclerosisScleroderma, Diffuse;Diffuse Cutaneous Systemic SclerosisDrug: IVA337;Drug: PlaceboInventiva PharmaNULLCompleted18 Years75 YearsAll145Phase 2Bulgaria;France;Germany;Italy;Netherlands;Poland;Slovenia;Spain;Switzerland;United Kingdom
98EUCTR2015-001617-27-DE
(EUCTR)
23/10/201528/08/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
99EUCTR2015-001617-27-IT
(EUCTR)
18/09/201517/06/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Switzerland;Italy
100EUCTR2015-001617-27-GB
(EUCTR)
16/09/201517/07/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis (DcSSc) - IVA337 SSc POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 19.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2015-001617-27-ES
(EUCTR)
08/09/201510/07/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis. - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland
102NCT02558543
(ClinicalTrials.gov)
September 201531/8/2015Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic SclerosisSubcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy AssessmentScleroderma, SystemicDrug: Stromal Vascular fraction;Drug: Ringer lactateAssistance Publique Hopitaux De MarseilleNULLTerminated18 YearsN/AAll40Phase 2France
103NCT04387825
(ClinicalTrials.gov)
August 13, 201510/5/2020Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic SclerosisLipograft Safety Enriched With Vascular Stromal Fraction Derived From Adipose Tissue, to Treatment of Digital Joint Fibrosis and Refractory Ischemic Digital Ulcers Caused by Systemic SclerosisSystemic SclerosisDrug: ADSVF application in the right handInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNational Council of Science and Technology, MexicoCompleted18 YearsN/AAll20Phase 2Mexico
104NCT02465437
(ClinicalTrials.gov)
August 20154/6/2015Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic SclerosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: JBT-101;Drug: Placebo;Drug: Part B Open-Label ExtensionCorbus Pharmaceuticals Inc.NULLActive, not recruiting18 Years70 YearsAll42Phase 2United States
105NCT02480335
(ClinicalTrials.gov)
June 26, 201515/6/2015The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic SclerosisThe Clinical Efficacy And Subclinical Effects on Arterial STIFFNESS of Bosentan Therapy Added to Usual Care in Patients With Systemic Sclerosis With Digital UlcersScleroderma, SystemicDrug: bosentanUniversity Medical Center GroningenActelionCompleted18 YearsN/AAll20Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03692299
(ClinicalTrials.gov)
June 201520/12/2016Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic SclerosisEfectividad de Saccharomyces Oulardii Para Reducir Los síntomas Gastrointestinales y Evitar el Sobrecrecimiento Bacteriano en Esclerosis sistémicaSystemic Sclerosis;Small Intestinal Bacterial OvergrowthDrug: Saccharomyces Boulardii Oral Tablet;Drug: MetronidazoleCoordinación de Investigación en Salud, MexicoNULLCompleted18 Years65 YearsAll39Phase 4Mexico
107NCT02371005
(ClinicalTrials.gov)
June 201518/2/2015Oral Manifestations of Systemic SclerosisOral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic MarkersScleroderma, SystemicRadiation: Cone Beam Computed Tomography (CBCT)University Hospital, Strasbourg, FranceNULLRecruiting18 YearsN/AAll90N/AFrance
108NCT02349009
(ClinicalTrials.gov)
June 201518/1/2015Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety TrialA Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety TrialSystemic SclerodermaDrug: C-82 Topical Gel, 1%;Drug: C-82 Topical Gel, PlaceboPrism Pharma Co., Ltd.NULLCompleted18 YearsN/AAll17Phase 1;Phase 2United States
109NCT02386436
(ClinicalTrials.gov)
April 21, 20156/3/2015A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy SubjectsA Phase I, Randomised, Double-blind (Sponsor Open), Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330811 in Healthy SubjectsScleroderma, SystemicDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years65 YearsAll41Phase 1United Kingdom
110NCT02411643
(ClinicalTrials.gov)
March 20153/3/2015Molecular Effects of Topical Calcipotriene on MorpheaMolecular Effects of Topical Calcipotriene on MorpheaMorphea;Localized SclerodermaDrug: topical calcipotriene 0.005% ointmentNorthwestern UniversityNULLTerminated18 YearsN/AAll2N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT02370784
(ClinicalTrials.gov)
February 201526/1/2015Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse SclerodermaThe Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic SclerosisSclerodermaDrug: atorvastatin;Drug: PlaceboRobyn T. Domsic, MD, MPHNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 Years70 YearsAll24Phase 2United States
112NCT02283762
(ClinicalTrials.gov)
January 15, 20153/11/2014Efficacy and Safety of Riociguat in Patients With Systemic SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)Scleroderma, SystemicDrug: Riociguat (Adempas, BAY63-2521);Drug: PlaceboBayerNULLCompleted18 YearsN/AAll121Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;New Zealand;Switzerland;Turkey;United Kingdom;Czech Republic;Spain
113NCT02165111
(ClinicalTrials.gov)
January 201511/6/2014Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's SyndromeA Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin In Treating Scleroderma-Associated Raynaud's SyndromeScleroderma;Raynaud's SyndromeDrug: Onabotulinumtoxin A;Drug: sterile saline solutionJohns Hopkins UniversityAllerganCompleted18 YearsN/AAll40Phase 3United States
114NCT02642146
(ClinicalTrials.gov)
January 201524/12/2015Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort StudyRaynaud Disease;Systemic Sclerosis;Digital UlcerDrug: Calcium Channel Blockers;Drug: Phosphodiesterase Inhibitors;Drug: Endothelin receptor blocker;Drug: Prostanoids;Drug: Other vasodilatorSeoul National University HospitalNULLTerminated18 YearsN/AAll71Korea, Republic of
115NCT02363478
(ClinicalTrials.gov)
December 201429/1/2015Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)Systemic SclerosisDrug: buspironeLaikon General District Hospital, AthensNULLCompleted18 Years75 YearsAll22Early Phase 1Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT01862926
(ClinicalTrials.gov)
November 201422/5/2013Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILDA Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung DiseaseInterstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue DiseaseDrug: Rituximab;Drug: CyclophosphamideRoyal Brompton & Harefield NHS Foundation TrustImperial College London;University of East Anglia;University College London HospitalsActive, not recruiting18 Years80 YearsAll116Phase 2;Phase 3United Kingdom
117NCT02374320
(ClinicalTrials.gov)
November 201423/2/2015Exparel as a Nerve Block for Severe Hand PainChemical Sympathectomy Following Peripheral Nerve Block With Liposomal BupivacaineCREST Syndrome;Peripheral Vascular Disease;Raynaud Disease;Scleroderma, DiffuseDrug: liposomal bupivacaineJose Soberon, MDNULLTerminated18 YearsN/AAll14Phase 2;Phase 3United States
118NCT02228850
(ClinicalTrials.gov)
November 201420/8/2014Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic SclerosisA Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)Raynaud's Phenomenon Secondary to Systemic SclerosisDrug: Alprostadil;Other: PlaceboNexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)NULLCompleted18 Years79 YearsBoth35Phase 2United States
119NCT02047708
(ClinicalTrials.gov)
October 201422/1/2014Zibotentan Better Renal Scleroderma Outcome StudyA Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to SclerodermaScleroderma;Scleroderma Renal Crisis;Chronic Kidney DiseaseDrug: ZibotentanUniversity College, LondonMedical Research CouncilCompleted18 YearsN/AAll27Phase 2United Kingdom
120NCT02161406
(ClinicalTrials.gov)
September 20143/6/2014A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic SclerosisA Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.Diffuse Cutaneous Systemic SclerosisDrug: Abatacept;Drug: PlaceboDinesh Khanna, MD, MSBristol-Myers Squibb;National Institute of Allergy and Infectious Diseases (NIAID)Completed18 YearsN/AAll88Phase 2United States;Canada;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT02290613
(ClinicalTrials.gov)
July 1, 201431/10/2014Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
122NCT02213705
(ClinicalTrials.gov)
May 6, 201417/7/2014Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem CellsTreatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem CellsSYSTEMIC SCLERODERMA;ALLOGENEIC MESENCHYMAL STEM CELLS;ADULTBiological: INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLSAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting18 Years70 YearsAll20Phase 1;Phase 2France
123NCT01988506
(ClinicalTrials.gov)
January 6, 20147/11/2013Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaActive, not recruiting18 YearsN/AAll81Phase 2France
124NCT01933334
(ClinicalTrials.gov)
October 201323/8/2013Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)The LOTUSS Trial: An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone When Administered to Patients With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)Systemic SclerosisDrug: PirfenidoneGenentech, Inc.NULLCompleted18 Years75 YearsAll63Phase 2United States;Canada;Italy
125NCT01878526
(ClinicalTrials.gov)
June 20137/6/2013Gastroesophageal Reflux Treatment in SclerodermaThe Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic SclerosisGastroesophageal Reflux Disease;Systemic Sclerosis;SclerodermaDrug: Alginic acid;Drug: placebo (for domperidone);Drug: Domperidone;Drug: placebo (of alginic acid)Khon Kaen UniversityNULLCompleted18 Years65 YearsAll80Phase 3Thailand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT01804959
(ClinicalTrials.gov)
May 20133/3/2013Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal DiseaseA Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal DiseaseSystemic SclerosisDietary Supplement: Vivomixx probioticsSingapore General HospitalNULLUnknown status18 YearsN/AAll40Phase 2Singapore
127NCT03561233
(ClinicalTrials.gov)
May 20137/6/2018Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic SclerosisPrevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic SclerosisSystemic Sclerosis;Gastroesophageal Reflux;Proton Pubm InhibitorDrug: Omeprazole 20mgKhon Kaen UniversityThai Rheumatism AssociationCompleted18 YearsN/AAll250Phase 1NULL
128NCT01748084
(ClinicalTrials.gov)
April 9, 201310/12/2012Rituximab in Systemic SclerosisEvaluation of Rituximab in Systemic Sclerosis Associated PolyarthritisSystemic SclerosisDrug: Rituximab;Drug: Placebo (NaCl)Assistance Publique - Hôpitaux de ParisNULLCompleted18 Years80 YearsAll22Phase 2;Phase 3France
129NCT01785056
(ClinicalTrials.gov)
April 201328/1/2013IVIG Treatment in Systemic SclerosisA Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic SclerosisSystemic Sclerosis;Diffuse SclerodermaBiological: PrivigenGeorgetown UniversityCSL BehringUnknown status18 YearsN/AAll14N/AUnited States
130NCT01570764
(ClinicalTrials.gov)
January 14, 20132/4/2012Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung DiseaseIntravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung FibrosisDrug: Cyclophosphamide;Drug: PlaceboAssistance Publique - Hôpitaux de ParisHôpital Claude-HuriezCompleted18 YearsN/AAll40Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT02169752
(ClinicalTrials.gov)
September 20126/5/2014Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionAmbrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionPre-Pulmonary Atrial HypertensionDrug: AmbrisentanNational Jewish HealthNULLTerminated18 Years80 YearsAll7N/AUnited States
132NCT01895244
(ClinicalTrials.gov)
September 20121/7/2013Autologous Stem Cell Transplantation for Progressive Systemic SclerosisHighdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to ManifestationScleroderma;Cardiac Involvement;Autologous Stem Cell TransplantationDrug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cellsUniversity Hospital TuebingenNULLRecruiting18 Years65 YearsAll44Phase 2Germany
133NCT01559129
(ClinicalTrials.gov)
August 9, 201219/3/2012Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung DiseaseA Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung DiseaseScleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung DiseaseDrug: Pomalidomide (CC-4047);Drug: PlaceboCelgeneNULLTerminated18 Years80 YearsAll23Phase 2United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom
134NCT01670565
(ClinicalTrials.gov)
August 201215/8/2012Belimumab for the Treatment of Diffuse Cutaneous Systemic SclerosisBelimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis: A Phase 2a, Single-centered, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Pilot Study.Systemic SclerosisDrug: BelimumabHospital for Special Surgery, New YorkHuman Genome Sciences Inc.Completed18 YearsN/AAll20Phase 2United States
135EUCTR2010-023047-15-PL
(EUCTR)
17/07/201214/05/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2010-023047-15-IT
(EUCTR)
20/03/201228/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease Diffuse cutaneous systemic sclerosis with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Other descriptive name: Pomalidomide
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Poland;Spain;Australia;Germany;United Kingdom;Italy
137EUCTR2010-023047-15-DE
(EUCTR)
15/03/201208/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
138EUCTR2010-023047-15-GB
(EUCTR)
08/03/201215/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 17.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
139EUCTR2010-023047-15-ES
(EUCTR)
02/03/201219/01/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease diffuse cutaneous systemic sclerosis associated with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomida
Product Code: CC-4047
INN or Proposed INN: Pomalidomida
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden
140NCT02562079
(ClinicalTrials.gov)
March 201229/12/2014Vasculopathy, Inflammation and Systemic SclerosisVasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte ActivationSystemic SclerosisBiological: Blood samples;Biological: BiopsyUniversity Hospital, BordeauxSociété Française de RhumatologieCompleted18 Years75 YearsAll350N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT01532869
(ClinicalTrials.gov)
March 201210/2/2012A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic SclerosisA Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic SclerosisSclerosis, SystemicDrug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll87Phase 3United States;Canada;France;Germany;United Kingdom
142NCT01538719
(ClinicalTrials.gov)
December 201121/2/2012IL1-TRAP, Rilonacept, in Systemic SclerosisRandomized, Double-Blind, Placebo-Controlled Trial if IL1-TRAP, Rilonacept, in Systemic Sclerosis -A Phase I/II Biomarker TrialScleroderma;Systemic Sclerosis;Diffuse Scleroderma;Diffuse Systemic SclerosisDrug: Rilonacept;Other: PlaceboBoston UniversityRegeneron PharmaceuticalsCompleted18 YearsN/AAll24Phase 1;Phase 2United States
143NCT01474122
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic SclerosisDigital UlcersDrug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: PlaceboActelionNULLTerminated18 YearsN/AAll265Phase 3United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom
144NCT01474109
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic SclerosisSystemic Sclerosis;UlcersDrug: macitentan 3mg;Drug: macitentan 10mg;Drug: placeboActelionNULLCompleted18 YearsN/AAll289Phase 3United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine
145NCT02240888
(ClinicalTrials.gov)
October 20114/9/2014Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody ResponseRA;SLE;Vasculitis;Scleroderma;Sjögrens;SyndromeBiological: 0,5 mg Prevenar i.m.;Biological: 0,5 mg seasonal influenza vaccine i.m.Region SkaneNULLCompleted18 YearsN/AAll300N/ASweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT01445821
(ClinicalTrials.gov)
September 15, 201129/9/2011Autologous Stem Cell Systemic Sclerosis Immune Suppression TrialRandomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb)Scleroderma, SystemicBiological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: FludarabineNorthwestern UniversityNULLTerminated17 Years60 YearsAll44Phase 3United States
147NCT01413100
(ClinicalTrials.gov)
September 15, 20118/8/2011Scleroderma Treatment With Autologous Transplant (STAT) StudyA Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic SclerosisSystemic SclerodermaBiological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Biological: Filgrastim;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Plerixafor;Other: Quality-of-Life Assessment;Other: Questionnaire AdministrationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)Active, not recruitingN/A70 YearsAll20Phase 2United States;Canada
148NCT01086540
(ClinicalTrials.gov)
June 24, 201111/3/2010Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)Systemic Sclerosis-Associated PAHBiological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophenNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Completed18 Years75 YearsAll57Phase 2United States
149JPRN-UMIN000005550
2011/06/0123/05/2011Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Continue existing conventional therapies
Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of MedicineRheumatology Keio University,Rheumatology Tokyo Women's Medical University,Dermatology Osaka UniversityComplete: follow-up complete20years-old65years-oldMale and Female24Phase 2Japan
150NCT01639573
(ClinicalTrials.gov)
April 201118/6/2012Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic SclerosisCampath-1h as Immunoablative Therapy for Children and Adolescents With Treatment Refractory Systemic SclerosisSclerodermaDrug: CampathChildren's Hospital Los AngelesNULLWithdrawn8 Years18 YearsAll0Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2010-024005-13-GB
(EUCTR)
11/03/201130/12/2010A study of ORM-12741 for the prevention of blood vessel spasm brought on by cold temperature.Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-controlled, single centre crossover study in patient with Raynaud's phenomenon secondary to systemic sclerosis - Reino Raynaud's phenomenon secondary to systemic sclerosis (Raynaud's syndrome)
MedDRA version: 14.0;Level: LLT;Classification code 10037914;Term: Raynaud's syndrome;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: alpha-2C AR antagonist
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: Alpha-2C AR antagonist
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
152NCT01309997
(ClinicalTrials.gov)
March 20111/3/2011Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host DiseaseA Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell TransplantationGraft Versus Host Disease;Systemic SclerodermaDrug: imatinib mesylate;Biological: rituximabLee, StephanieNational Cancer Institute (NCI)Completed2 YearsN/AAll72Phase 2United States
153NCT01166139
(ClinicalTrials.gov)
July 20101/7/2010Nilotinib in the Treatment of Systemic SclerosisPhase IIA Study of the Safety and Tolerability of the Use of Nilotinib in the Treatment of Systemic SclerosisSystemic SclerosisDrug: Nilotinib (Tasigna)Hospital for Special Surgery, New YorkRudolph Rupert Scleroderma Program;Novartis PharmaceuticalsCompleted18 YearsN/AAll10Phase 2United States
154NCT01093885
(ClinicalTrials.gov)
February 201024/3/2010Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic SclerosisAn Open Label Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Treatment of Diffuse Systemic SclerosisSystemic Sclerosis;SclerodermaDrug: AmbrisentanUniversity of PennsylvaniaGilead SciencesCompleted19 Years90 YearsAll15N/AUnited States
155NCT01072669
(ClinicalTrials.gov)
February 201019/2/2010Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or FeetEvaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion ImagingIschemiaDrug: ambrisentanSoumya ChatterjeeGilead SciencesCompleted18 Years70 YearsAll20N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT01047072
(ClinicalTrials.gov)
January 201011/1/2010Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic SclerosisPhase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic SclerodermaDrug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationFred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumNational Cancer Institute (NCI)Withdrawn18 Years65 YearsBoth0Phase 2United States
157NCT01042158
(ClinicalTrials.gov)
January 20104/1/2010A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisA Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisPulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary HypertensionDrug: tadalafil and ambrisentan upfront combination therapyJohns Hopkins UniversityNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford UniversityCompleted18 YearsN/AAll25Phase 4United States
158NCT00883129
(ClinicalTrials.gov)
September 200916/4/2009Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: Cyclophosphamide;Drug: PlaceboMichael RothNational Heart, Lung, and Blood Institute (NHLBI);Hoffmann-La RocheCompleted18 YearsN/AAll142Phase 2United States
159NCT00848107
(ClinicalTrials.gov)
September 200916/2/2009Open-Label Study of Oral Treprostinil in Digital UlcersDigital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension StudySystemic SclerosisDrug: treprostinil diethanolamineUnited TherapeuticsNULLTerminated18 YearsN/AAll115Phase 2United States;Canada;United Kingdom
160NCT00962923
(ClinicalTrials.gov)
August 200919/8/2009Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)Systemic Sclerosis;Mesenchymal Stem CellsBiological: Allogeneic Mesenchymal Stem Cells (AlloMSC)The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNULLRecruiting15 Years65 YearsBoth20Phase 1;Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT00775463
(ClinicalTrials.gov)
May 200917/10/2008Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil DiethanolamineDISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter StudySystemic Sclerosis;SclerodermaDrug: treprostinil diethanolamine;Drug: placeboUnited TherapeuticsNULLCompleted18 YearsN/AAll148Phase 2United States;Canada;United Kingdom
162NCT01051960
(ClinicalTrials.gov)
March 200919/1/2010Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With AmbrisentanExercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot StudySystemic Sclerosis;Shortness of Breath;Pulmonary HypertensionDrug: AmbrisentanUniversity of California, Los AngelesGilead SciencesCompleted18 Years80 YearsAll12Phase 4United States
163NCT00764309
(ClinicalTrials.gov)
January 20091/10/2008Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary FibrosisAn Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Interstitial FibrosisSclerodermaDrug: dasatinibBristol-Myers SquibbNULLCompleted18 YearsN/AAll47Phase 1;Phase 2United States
164NCT00769028
(ClinicalTrials.gov)
December 20087/10/2008AIMSPRO in Established Diffuse Cutaneous Systemic SclerosisA Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Hyperimmune caprine serum;Drug: AlbuminDaval International LimitedNULLActive, not recruiting18 YearsN/ABoth20Phase 2United Kingdom
165NCT00442611
(ClinicalTrials.gov)
November 20081/3/2007A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic SclerosisScleroderma, Diffuse;Scleroderma, SystemicDrug: Abatacept;Drug: PlaceboStanford UniversityBristol-Myers SquibbCompleted18 YearsN/AAll10Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT00984932
(ClinicalTrials.gov)
September 200824/9/2009Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary HypertensionThe Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled TrialSystemic SclerosisDrug: RosuvastatinFaculty of Medicine, University of AlexandriaNULLCompletedN/AN/ABoth40Phase 3Egypt
167EUCTR2005-003775-21-GB
(EUCTR)
14/08/200810/11/2005Effects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosisEffects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosis Systemic sclerosis (also termed 'scleroderma')Salford Royal Hospitals NHS TrustUniversity of ManchesterNot Recruiting Female: yes
Male: yes
36Phase 4United Kingdom
168NCT00725361
(ClinicalTrials.gov)
June 200828/7/2008A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis.n Ulcer;Scleroderma, SystemicDrug: AmbrisentanStanford UniversityNULLCompleted18 YearsN/AAll20N/AUnited States
169NCT00613171
(ClinicalTrials.gov)
January 200825/1/2008Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Patients With Systemic SclerosisA Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic SclerosisSystemic Sclerosis, SclerodermaDrug: STI571Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll27Phase 2United States;Germany;Italy;Switzerland;United Kingdom
170EUCTR2007-001508-19-IT
(EUCTR)
06/09/200729/07/2008TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - NDTRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND GVH CRONICA ESTESA
MedDRA version: 9.1;Level: LLT;Classification code 10018651;Term: Graft versus host disease
Trade Name: GLIVEC
INN or Proposed INN: Imatinib
AZIENDA OSPEDALIERA S. CARLONULLNot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2007-002015-38-ES
(EUCTR)
23/08/200702/07/2007ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSISENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICASKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
172NCT00555581
(ClinicalTrials.gov)
August 20077/11/2007Imatinib Mesylate (Gleevec) in the Treatment of Systemic SclerosisPhase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate (Gleevec) in the Treatment of Systemic SclerosisSystemic SclerosisDrug: Imatinib MesylateHospital for Special Surgery, New YorkNovartis PharmaceuticalsCompleted18 YearsN/AAll30Phase 2United States
173NCT00684255
(ClinicalTrials.gov)
August 200722/5/2008Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)Systemic Lupus Erythematosus;Systemic SclerosisProcedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: CampathNew York Medical CollegeNULLTerminated7 Years50 YearsAll1Phase 1United States
174NCT00512902
(ClinicalTrials.gov)
August 20076/8/2007A Study Using The Experimental Drug Called Imatinib (Gleevec) in Subjects With Systemic SclerosisPilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic SclerosisAlveolitis;Systemic SclerosisDrug: ImatinibUniversity of California, Los AngelesNovartis PharmaceuticalsCompleted18 YearsN/AAll20Phase 1;Phase 2United States
175NCT00506831
(ClinicalTrials.gov)
July 200724/7/2007Imatinib in Systemic SclerosisA Pilot Study of Imatinib in the Treatment of Refractory Systemic SclerosisScleroderma, SystemicDrug: Imatinib mesylateStanford UniversityNULLCompleted18 Years80 YearsAll9Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT00498615
(ClinicalTrials.gov)
April 20076/7/2007A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's PhenomenonEfficacy, Tolerability and Biology of a Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's PhenomenonRaynaud;SclerodermaDrug: FasudilJohns Hopkins UniversityNULLCompleted18 Years80 YearsAll17Phase 3United States
177NCT00622895
(ClinicalTrials.gov)
September 1, 200622/2/2008Allogeneic Hematopoietic Cell Transplantation for Severe Systemic SclerosisAllogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic Scleroderma;Severe Systemic SclerosisDrug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsyFred Hutchinson Cancer Research CenterNational Institute of Allergy and Infectious Diseases (NIAID)CompletedN/A70 YearsAll3Phase 1;Phase 2United States
178NCT00377455
(ClinicalTrials.gov)
September 200614/9/2006Placebo Controlled Trial of Bosentan in Scleroderma PatientsPlacebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary HypertensionSystemic Scleroderma;Pulmonary HypertensionDrug: Bosentan;Drug: PlaceboGeorgetown UniversityActelionTerminated18 YearsN/AAll5Phase 2United States
179NCT00333437
(ClinicalTrials.gov)
May 20062/6/2006Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung InvolvementPulmonary Involvement in Scleroderma: Safety and Efficacy of Mycophenolate Mofetil in Scleroderma PatientsScleroderma, SystemicDrug: Mycophenolate mofetilUniversity of California, San FranciscoRoche Pharma AGCompleted21 Years70 YearsAll7N/AUnited States
180NCT00278525
(ClinicalTrials.gov)
September 200515/1/2006Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic SclerodermaTrial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized TrialSYSTEMIC SCLERODERMADrug: standard of care;Procedure: stem cell transplantationNorthwestern UniversityNULLCompletedN/A60 YearsAll19Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT00860548
(ClinicalTrials.gov)
June 200511/3/2009SCOT Scleroderma Treatment Alternative Registry (STAR Registry)An Observational, Long-term Follow-up Study of Eligible Individuals Declining To Participate in the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study (SCSSc-02)Scleroderma, Systemic;SclerosisDrug: currently available therapy in the communityNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years69 YearsAll19N/AUnited States
182NCT00114530
(ClinicalTrials.gov)
June 200515/6/2005Scleroderma: Cyclophosphamide or Transplantation (SCOT)A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)Scleroderma, Systemic;Sclerosis;Autoimmune DiseaseBiological: mHSCT;Drug: cyclophosphamideNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years69 YearsAll75Phase 2;Phase 3United States;Canada
183NCT00282425
(ClinicalTrials.gov)
May 200524/1/2006Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic SclerosisNon-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic SclerosisSclerodermaBiological: Hematopoietic stem cell transplantationRichard Burt, MDNULLTerminated18 Years55 YearsBoth8Phase 1United States
184NCT00319696
(ClinicalTrials.gov)
July 8, 200427/4/2006Bosentan in Digital UlcersLong-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital UlcersDigital UlcersDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mgActelionNULLCompleted18 YearsN/AAll116Phase 3United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom
185NCT00025818
(ClinicalTrials.gov)
May 200126/10/2001Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye SyndromeKeratoconjunctivitis Sicca;Sjogren's Syndrome;Lupus Erythematosus, Systemic;Arthritis, Rheumatoid;Scleroderma, SystemicDrug: Ophthalmic EmulsionAllerganNULLCompleted18 YearsN/ABoth290Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT00501995
(ClinicalTrials.gov)
February 200113/7/2007High Dose Cyclophosphamide for Treatment of SclerodermaHigh Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma)SclerodermaDrug: IV CyclophosphamideJohns Hopkins UniversityNULLCompleted18 Years70 YearsAll6Phase 3United States
187NCT00005675
(ClinicalTrials.gov)
April 200026/5/2000Oral Type I Collagen for Relieving SclerodermaMulticenter Phase II Trial of Oral Type I Bovine Collagen in SclerodermaScleroderma;Connective Tissue DiseasesDrug: Oral bovine type I collagen;Drug: PlaceboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Wayne State University;University of California, Los Angeles;UTHSC;MUSC;Beth Israel Medical Center;University of Alabama at Birmingham;Johns Hopkins University;Georgetown University;Baltimore VA Medical Center;Northwestern UniversityCompleted18 YearsN/ABoth168Phase 2United States
188NCT00004563
(ClinicalTrials.gov)
August 19999/2/2000Scleroderma Lung DiseaseCyclophosphamide Versus Placebo in Scleroderma Lung StudyLung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, SystemicDrug: Cyclophosphamide;Drug: PlaceboThe University of Texas Health Science Center, HoustonNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll158Phase 3NULL
189NCT00058578
(ClinicalTrials.gov)
June 19998/4/2003Stem Cell Transplant to Treat Patients With Systemic SclerosisAutologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic SclerosisSystemic SclerosisDrug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Procedure: Leukopheresis;Procedure: Total Body IrradiationBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineCompleted18 Years65 YearsAll24Phase 1United States