S95011 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
53シェーグレン症候群4

53. シェーグレン症候群


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT04605978
(ClinicalTrials.gov)
August 3, 202119/10/2020Efficacy and Safety of S95011 in Primary Sjögren's Syndrome PatientsA Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled StudyPrimary Sjögren's SyndromeDrug: S95011 concentrate for solution for infusion;Drug: Placebo concentrate for solution for infusionInstitut de Recherches Internationales ServierADIR, a Servier Group companyActive, not recruiting18 Years75 YearsAll48Phase 2United States;Australia;France;Germany;Hungary;Spain;United Kingdom;Canada
2EUCTR2020-001526-59-DE
(EUCTR)
21/01/202103/08/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary 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: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2France;United States;Hungary;Canada;Spain;Australia;Germany;United Kingdom
3EUCTR2020-001526-59-GB
(EUCTR)
20/10/202014/07/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary 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: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom
4EUCTR2020-001526-59-HU
(EUCTR)
06/10/202028/07/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary 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: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2France;United States;Hungary;Canada;Spain;Australia;Germany;United Kingdom