97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

  
29 trials found
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PhaseCountries
1NCT05684484
(ClinicalTrials.gov)
February 1, 202326/12/2022Role of Roflumilast in Ulcerative ColitisClinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.Ulcerative ColitisDrug: Roflumilast 500 Ug ORAL TABLET [Daliresp];Drug: corticosteroids +immune suppressive +amino salicylic acidTanta UniversityNULLNot yet recruiting15 Years80 YearsAll52Phase 4NULL
2NCT04999228
(ClinicalTrials.gov)
November 1, 20215/8/2021Top Down Versus Step up in Pediatric Ulcerative ColitisFirst-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative ColitisUlcerative Colitis;Infliximab;ChildrenDrug: Infliximab;Drug: CorticosteroidsChildren's Hospital of Fudan UniversityNULLRecruiting6 Years18 YearsAll40Phase 4China
3NCT04879966
(ClinicalTrials.gov)
May 17, 20216/5/2021A Cohort Study Comparing IFX to CS for Moderate to Severe UCA Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative ColitisModerate to Severe Ulcerative ColitisDrug: Infliximab;Drug: CorticosteroidSixth Affiliated Hospital, Sun Yat-sen UniversityNULLRecruiting18 Years70 YearsAll342China
4NCT03942861
(ClinicalTrials.gov)
February 21, 201925/4/2019Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Ulcerative Colitis;Ultrasound Therapy; ComplicationsDrug: Solu-MedrolCopenhagen University Hospital at HerlevNULLRecruiting18 Years70 YearsAll50Denmark
5EUCTR2017-000937-30-AT
(EUCTR)
22/02/201803/01/2018Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Spain;Poland;Belgium;Austria;Germany
6EUCTR2017-000937-30-PL
(EUCTR)
13/12/201725/09/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Spain;Belgium;Poland;Austria;Germany
7EUCTR2017-000937-30-ES
(EUCTR)
27/11/201710/10/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Poland;Belgium;Spain;Austria;Germany
8EUCTR2017-000937-30-FR
(EUCTR)
07/11/201719/09/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Spain;Poland;Belgium;Austria;Germany
9EUCTR2016-001170-15-ES
(EUCTR)
19/10/201702/08/2017Intravenous corticosteroids in moderate ulcerative colitisEfficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM Moderate flares of Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Urbason
INN or Proposed INN: methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE
GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 4Spain
10EUCTR2017-000937-30-DE
(EUCTR)
10/10/201725/09/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Spain;Poland;Belgium;Austria;Germany
11NCT03093259
(ClinicalTrials.gov)
October 1, 201717/3/2017ABX464 in Subjects With Moderate to Severe Active Ulcerative ColitisPhase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or CorticosteroidsUlcerative ColitisDrug: ABX464;Drug: Placebo oral capsuleAbivax S.A.NULLCompleted18 Years70 YearsAll32Phase 2Belgium
12EUCTR2017-000937-30-BE
(EUCTR)
29/09/201703/08/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Spain;Poland;Belgium;Austria;Germany
13NCT02425852
(ClinicalTrials.gov)
December 201621/4/2015A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe ColitisA Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe ColitisUlcerative ColitisDrug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: HydrocortisoneGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLRecruiting18 YearsN/AAll146Phase 4France
14NCT02665845
(ClinicalTrials.gov)
June 13, 201625/1/2016Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial.Ulcerative ColitisDrug: 5-ASA;Drug: CorticosteroidsCentre Hospitalier Universitaire de Saint EtienneNULLCompleted18 YearsN/AAll160Phase 3France;Greece;Israel;Italy;Korea, Republic of;Serbia
15NCT04564638
(ClinicalTrials.gov)
March 1, 201511/9/2020Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous CorticosteroidsLong-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous CorticosteroidsUlcerative ColitisDrug: CorticosteroidTampere University HospitalNULLCompletedN/AN/AAll217NULL
16NCT02033408
(ClinicalTrials.gov)
January 20143/12/2013Manipulating the Microbiome in IBD by Antibiotics and FMTManipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled TrialExacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's ColitisDrug: AB (antibiotics);Drug: CS (corticosteroids) OnlyShaare Zedek Medical CenterNULLCompleted2 Years75 YearsAll28N/ACanada;Finland;Israel;Italy;Poland;Spain
17NCT01941589
(ClinicalTrials.gov)
September 201330/8/2013Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative ColitisCombination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.Ulcerative ColitisDrug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids onlySheba Medical CenterNULLCompleted18 YearsN/AAll149Phase 4China;France;Greece;Israel;Italy;Korea, Republic of;Serbia
18NCT02922374
(ClinicalTrials.gov)
January 201328/9/2016Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative ColitisUlcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational StudyAcute Severe Colitis (ASC)Drug: corticosteroidsJinling Hospital, ChinaNULLActive, not recruiting18 YearsN/ABoth117Phase 1/Phase 2China
19NCT01536535
(ClinicalTrials.gov)
July 10, 201216/2/2012Predicting Response to Standardized Pediatric Colitis TherapyMulticenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.Ulcerative ColitisDrug: Mesalazine;Drug: IV Corticosteroid;Drug: Oral Corticosteroids;Other: Additional Therapies;Procedure: ColectomyConnecticut Children's Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed4 Years17 YearsAll431Phase 4United States;Canada
20EUCTR2009-015077-12-GB
(EUCTR)
23/11/200917/09/2009The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasiaThe use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia chronic ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Budenofalk 2mg rectal foam
Product Name: Budenofalk rectal foam
University Hospital Birmingham NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
21EUCTR2007-006692-37-GB
(EUCTR)
10/04/200825/01/2008 The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM
Imperial College LondonNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
22EUCTR2006-004303-19-BE
(EUCTR)
08/06/200707/02/2007A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab
Cerimon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
135Czech Republic;United Kingdom;Belgium
23EUCTR2006-004303-19-CZ
(EUCTR)
09/05/200720/02/2007A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab
Cerimon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
181United Kingdom;Czech Republic;Belgium
24EUCTR2006-004303-19-SK
(EUCTR)
04/05/200708/03/2007A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab
Cerimon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
181Phase 2Czech Republic;Slovakia;Belgium;United Kingdom
25EUCTR2006-004303-19-GB
(EUCTR)
25/04/200706/12/2006A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab
Cerimon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
135Phase 2Czech Republic;Slovakia;Belgium;United Kingdom
26NCT00430898
(ClinicalTrials.gov)
January 200731/1/2007Basiliximab in Moderate to Severe Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative ColitisUlcerative ColitisDrug: BasiliximabCerimon PharmaceuticalsNULLCompleted18 Years75 YearsBoth181Phase 2United States;Belgium;Czech Republic;India;Poland;Russian Federation;Slovakia;Ukraine;United Kingdom
27NCT00269438
(ClinicalTrials.gov)
December 200522/12/2005New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative ColitisPhase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of TherapyUlcerative ColitisDrug: 5 ASA, enemas, suppositories, corticosteroidsBausch Health Americas, Inc.NULLCompleted18 Years80 YearsAll225Phase 3United States
28NCT00267306
(ClinicalTrials.gov)
January 200416/12/2005Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative ColitisA Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous CorticosteroidsSevere Ulcerative ColitisDrug: VisilizumabFacet BiotechPDL BioPharma, Inc.Completed16 Years70 YearsBoth144Phase 1/Phase 2United States
29NCT00032305
(ClinicalTrials.gov)
March 200214/3/2002Research Study in Patients With Severe Ulcerative ColitisA Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to CorticosteroidsUlcerative ColitisDrug: VisilizumabFacet BiotechNULLCompleted18 Years70 YearsBoth20Phase 2/Phase 3United States