DDrare: Database of Drug Development for Rare Diseases

53. シェーグレン症候群
［臨床試験数：234，薬物数：270（DrugBank：85），標的遺伝子数：49，標的パスウェイ数：174］

Searched query = "Sjogren syndrome", "Sjögren syndrome"
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.

Drug = 0.005% Lacripep; 0.01% Lacripep; 0.02% Fm, SH; 0.02% Fm, SH, 0.05% CsA; 0.02% Fm, SH, AS; 0.9% sodium chloride; 13-valent pneumococcal conjugate vaccine; 1643368-58-4; 18F-FDG; 23-valent pneumococcal polysaccharide vaccine; 552-02; ABATACEPT; ABBV-323; ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED; AMG 557/MEDI5872; AS; ASCs; Abatacept; Abatacept Placebo; Abatacept SC; Acycloguanosine; Alginate; Allogeneic Mesenchymal Stem Cells (AlloMSC); Allogeneic Stem Cell Transplant; Allogeneic adipose tissue-derived stromal/stem cells; Aloe vera; Anti-CD28dAb; Anti-CD28dab; Anti-pandemic H1N1 influenza vaccine; Artificial Saliva; Autologous Serum 20%; Autologous Serum 50%; Autologous Stem Cell Transplant; Autologous serum; Aún no establecido; B / Phuket / 3073/2013-like virus); BELIMUMAB; BENLYSTA; BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO; BMS-188667; BMS-931699; BMS-986142; BMS-986195; BMS986142; BMS986195; BTK Inhibitor; BUPI5; BUPIVACAINE HYDROCHLORIDE; Baminercept; Belimumab; Benlysta; Benlysta (Belimumab); Biopsy of the labial salivary gland; Blood sample; Branebrutinib; Bupivacaine; Bupizenge; CDZ173; CFZ533; CFZ533 (iscalimab); CFZ533 active - Cohort 1; CFZ533 active - Cohort 2; CFZ533 active - Cohort 3; CFZ533 active -Cohort 3; CICLOSPORIN; CO; CSCC_ASC(22); Calcium; Calcium carbonate; Calcium carbonate D; Carbomer; Carbomer 974P; Carbonate; Cathepsin S; Cathepsin S Inhibitor; Cathepsin S inhibitor; Cellulose; Cevimeline; Chloride; Ciclosporin; Citric Acid based Mouthwash; Citric acid; Coconut; Cryostor CS10; CsA; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine A; Cyclosporins; Dehydroepiandrosterone; Dexamethasone; Dexamethasone Parotid Irrigation; Diquafosol; Dornase alfa; E4; EFALIZUMAB; Efalizumab; Endura; Estetrol; Etanercept; FILGOTINIB; FMP-30; Filgotinib; GS-4059; GS-6034; GS-9876; GSK2618960; GSK2618960 2 mg/kg; Gadoterate; Ginseng; Glycyrrhiza; Gold; HGS1006, LymphoStat-B; HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA; HYDROCORTISONE SODIUM PHOSPHATE; HYDROXYCHLOROQUINE; HrIL-2 active; Hyaluronate; Hyaluronic acid; Hydrocortisone; Hydroxychloroquine; IL-2; ISCALIMAB; Ianalumab; Iguratimod; Ikervis; Impact; Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; Iscalimab; KCT-0809 ophthalmic solution; Korean Red Ginseng; LEFLUNOMIDE; LO2A eye drops; LOU064; LY3090106; Lacryvisc; Lanraplenib; Leflunomide; Leflunomide Mylan; Leflunomide mylan; Leniolisib; Levocarnitine; Levofloxacin; Licorice; LimphoStat-B; Lipitor®; Liposic; MABTHERA; MABTHERA - 1 FIALA 500 MG 50 ML; MEDI4920; METILPREDNISOLONE; MabThera; MabThera (Rituximab); MabThera (rituximab); Maxidex; Meglumine; Methotrexate; Methyl cellulose; MighTeaFlow; Mizoribine; Mucosta; Mycophenolate; Mycophenolate mofetil; Mycophenolate sodium; NGX267; NaCl 0,9%; Nivolumab; ORENCIA; ORENCIA 125 mg solution for injection in pre-filled syringe; OSE-127; Olive; Olive Oil; Olive oil; Omalizumab; Ophthalmic Emulsion; Orencia; Other: 0.02% Fm, SH, tBCL; Other: No treatment; Other: autologous serum and rebamipide 2%; Other: carboxy methyl cellulose; Other: natural herbs of coconut, aloe vera, and pepperint; P-552; PAH; PARACETAMOLO; PRP injection; Parsaclisib; Phosphate; Pilocarpine; Pilocarpine Hydrochloride; Plaquenil; Prednisone; Privigen 100 mg/ml, solution pour perfusion; Privigen® 100mg/ml at the dose of 2g/kg of body weight; Probiotic Product - Cap; Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine; Procedure: Minor Salivary gland (labial) biopsy; Procedure: Sialoendoscopy; Procedure: pilocarpine; RC18 160 mg; RC18 240 mg; RITUXIMAB; RO545-9072/F03; RO5459072; RSLV-132; Radiation: 11C-MET PET/CT Imaging; Radiation: 18F-FDG PET/CT Imaging; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Ravagalimab; Rebamipide; Refresh Endura; Remibrutinib; Restasis; Rituxan (US, Canada, Japan), MabThera (rest of world); Rituximab; Rituximab (anti-CD20); Rituximab, Mabthera; S95011; S95011 concentrate for solution for infusion; SALINE; SAR441344; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; SOLU-MEDROL; SS-1; SVS20; Saline; Sandimmun Optoral; Sodium chloride; Sodium hyaluronate; Softacort; Solu-Medrol; Solu-medrol; Standard care Hyaluronic acid eye drops; Sulfate; Systane Ultra UD; TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE; TCM (Gan-Lu-Yin)GLY; Tachipirina; Tacrolimus; Tears Naturale Forte; Tetracycline; Thalidomide; Thymosin Beta 4 eye drops; Thymosin beta 4; Tibulizumab; Tibulizumab (LY3090106); Tirabrutinib; Tocilizumab; Tofacitinib; UCB5857; Ustekinumab; VAY736; VAY736 antibody; VAY736 higher dose; VAY736 lower dose; VIB4920; VIB7734; Vehicle Control; Vitamin A; Vitamin D3; Water; XYZAL - 20 COMPRESSE RI; Xeros; Xylitol; Xyzal; Yellow Fever Vaccine; Yellow Fever vaccine (17D); [NA]; [na]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-000511-77-HU (EUCTR)	13/11/2020	22/10/2020	Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)	A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA	Sjögren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: SAR441344 Other descriptive name: SAR441344	Sanofi-Aventis Recherche & Développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 2	United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of
2	EUCTR2020-000511-77-DE (EUCTR)	12/11/2020	24/09/2020	Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)	A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA	Sjögren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: SAR441344 Other descriptive name: SAR441344	Sanofi-Aventis Recherche & Développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 2	United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of
3	NCT04572841 (ClinicalTrials.gov)	November 12, 2020	28/9/2020	Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)	A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS)	Sjögren's Syndrome	Drug: SAR441344;Drug: Placebo	Sanofi	NULL	Recruiting	18 Years	80 Years	All	88	Phase 2	United States;Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-000511-77-HU
(EUCTR)

13/11/2020

22/10/2020

Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)

A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA

Sjögren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: SAR441344
Other descriptive name: SAR441344

Sanofi-Aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 2

United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of

EUCTR2020-000511-77-DE
(EUCTR)

12/11/2020

24/09/2020

Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)

Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: SAR441344
Other descriptive name: SAR441344

Sanofi-Aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 2

United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of

NCT04572841
(ClinicalTrials.gov)

November 12, 2020

28/9/2020

Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS)

Sjögren's Syndrome

Drug: SAR441344;Drug: Placebo

Sanofi

NULL

Recruiting

18 Years

80 Years

All

Phase 2

United States;Canada