ST-0529 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎9

97. 潰瘍性大腸炎


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
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
1EUCTR2018-003349-41-DE
(EUCTR)
30/10/201919/12/2018Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLNot RecruitingFemale: yes
Male: yes
380Phase 2Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany;Belarus;Serbia;United States;Ukraine
2EUCTR2018-003349-41-IT
(EUCTR)
16/07/201917/06/2021Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis - CYC-202 Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: [FP-CYA-050]
INN or Proposed INN: CICLOSPORIN
Product Name: ST-0529
Product Code: [FP-CYA-053]
INN or Proposed INN: CICLOSPORIN
Sublimity Therapeutics HoldCo LimitedNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
3EUCTR2018-003349-41-FR
(EUCTR)
11/07/201927/05/2019Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Product Name: ST-0529
Product Code: FP-CYA-053
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Belarus;Serbia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
4EUCTR2018-003349-41-RO
(EUCTR)
01/07/201909/05/2022Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Product Name: ST-0529
Product Code: FP-CYA-053
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Belarus;Serbia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
5EUCTR2018-003349-41-BG
(EUCTR)
29/05/201927/02/2019Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLNot RecruitingFemale: yes
Male: yes
380Phase 2Spain;Belarus;Serbia;United States;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
6EUCTR2018-003349-41-GB
(EUCTR)
28/03/201921/12/2018Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 2Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
7EUCTR2018-003349-41-PL
(EUCTR)
27/02/201915/01/2019Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Product Name: ST-0529
Product Code: FP-CYA-053
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLNot RecruitingFemale: yes
Male: yes
280Phase 2Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
8EUCTR2018-003349-41-HU
(EUCTR)
19/02/201908/01/2019Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLNot RecruitingFemale: yes
Male: yes
380Phase 2Belarus;Serbia;United States;Spain;Ukraine;Ireland;Turkey;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany
9NCT03844932
(ClinicalTrials.gov)
January 24, 201931/1/2019A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: ST-0529Sublimity Therapeutics Holdco LimitedDr. Falk Pharma GmbHTerminated18 Years75 YearsAll235Phase 2United States;Belarus;Bulgaria;Canada;France;Germany;Hungary;Ireland;Israel;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom