Trials / Completed
CompletedNCT02647866
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
A 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 UC
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Kyowa Kirin, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.
Detailed description
A Phase 2, double-blind clinical study of multiple ascending doses of KHK4083 (or placebo) with an Long-term Extension Therapy (LTE) phase will be conducted in approximately 60 randomized adult subjects with moderately active UC who have a documented unsuccessful previous treatment. The Treatment Period includes double-blind Induction Therapy (12 weeks) and Open-label Therapy (OLE) phase (40 weeks) for eligible subjects at Week 12. Subjects already enrolled in the double-blind, long-term extension (LTE) under preceding versions of the protocol who worsen may be eligible to transition to the OLE up to Week 28. The Follow Up Period after the last administration will be for up to 16 weeks.
Conditions
- Ulcerative Colitis
- Digestive System Diseases
- Colitis, Ulcerative
- Colitis
- Gastrointestinal Diseases
- Inflammatory Bowel Diseases
- Intestinal Diseases
- Colonic Diseases
- Autoimmune Disease
- Abdominal Pain
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KHK4083 | IV Infusion |
| DRUG | Placebo | IV Infusion |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2018-09-01
- Completion
- 2018-10-01
- First posted
- 2016-01-06
- Last updated
- 2024-04-26
- Results posted
- 2020-03-05
Locations
23 sites across 7 countries: United States, Czechia, Hungary, Poland, Romania, Russia, Serbia
Source: ClinicalTrials.gov record NCT02647866. Inclusion in this directory is not an endorsement.