KHK4083 ( 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5

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_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT02985593
(ClinicalTrials.gov)
December 201628/11/2016A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative ColitisA Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative ColitisHealthy Men and Subjects With Ulcerative ColitisDrug: KHK4083;Drug: PlaceboKyowa Kirin Co., Ltd.NULLCompleted20 YearsN/AAll155Phase 1Japan
2NCT02647866
(ClinicalTrials.gov)
June 20168/12/2015Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) & Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderately Active UCUlcerative Colitis;Digestive System Diseases;Colitis, Ulcerative;Colitis;Gastrointestinal Diseases;Inflammatory Bowel Diseases;Intestinal Diseases;Colonic Diseases;Autoimmune Disease;Abdominal PainDrug: KHK4083;Drug: PlaceboKyowa Kirin Pharmaceutical Development, Inc.NULLCompleted18 YearsN/AAll66Phase 2United States;Czechia;Hungary;Poland;Romania;Russian Federation;Serbia;Czech Republic;Puerto Rico
3EUCTR2015-001555-69-PL
(EUCTR)
28/04/201622/12/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation
4EUCTR2015-001555-69-CZ
(EUCTR)
07/03/201614/12/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation
5EUCTR2015-001555-69-HU
(EUCTR)
15/01/201617/11/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation