At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 66 enrolled
Drug / intervention
KHK4083 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating KHK4083 and Placebo for Ulcerative Colitis and 9 related conditions. Completed, enrolled 66 participants across 23 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases, Colonic Diseases, Autoimmune Disease, Abdominal Pain
CountriesCzechia, Hungary, Poland, Romania, Russia, Serbia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartJun 2016
Primary CompletionSep 2018
Study CompletionOct 2018
TodayJul 2026
First PostedJan 6, 2016
Enrollment StartJun 1, 2016
Primary CompletionSep 1, 2018
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.5 years ago
Interventions
KHK4083drug
IV Infusion
Placebodrug
IV Infusion