Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Abdominal Pain
• Autoimmune Disease
• Autoimmune Diseases
• Colitis
• Colitis, Ulcerative
• Colonic Diseases
• Digestive System Diseases
• Gastrointestinal Diseases
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

• NCT number: NCT02647866
• Study type: Interventional
• Source: Kyowa Kirin Co., Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Completion date: October 2018