Recruiting studies for ulcerative colitis

The IBD clinical trial unit currently has several sponsor studies available for patients with ulcerative colitis.

The following studies are open for recruitment:

Sponsor: Bristol-Myers Squibb Research and Development
Protocol: IM011127
IP: BMS-986165 (0ral)

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

Study IM011127 is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 12 mg twice daily (BID) orally (PO) in subjects with moderate to severe ulcerative colitis (UC).

The duration of study participation is approximately 60 weeks (420 days) in 4 periods, as follows:
• Screening period: up to 4 weeks
• Double-blind treatment period: 12 wee
• OLE period: up to 40 weeks
• Posttreatment follow-up period: 4 weeks

INSPIRE
Sponsor: AbbVie Inc.
Protocol: M16-067
IP: risankizumab ( iv/sc)

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is a phase 2b/3 double-blind, placebo-controlled, multicenter RCT to evaluate the efficacy and safety of risankizumab (IL23 p19 antibody) in subjects with moderate to severe active ulcerative colitis.

Induction: 12 weeks risankizumab 1800mg, 1200mg, 600mg or placebo iv, ratio 1:1:1:1
Maintenance: roll over to study M16-066 for 52 weeks risankizumab or placebo sc, ratio 1:1:1
Extension/open-label: open-label 180mg or 360mg risankizumab sc. Continuation in M16-066 study up to 300 weeks or until discontinuation

CALDOSE-1
Sponsor: Immunic AG
Protocol: P2-IMU-838-UC
IP: IMU-838 (oral )

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 (vidofludimus calcium) for induction and maintenance therapy in moderate-to-severe ulcerative colitis.

After eligibility patients are randomized 1:1:1:1 to oral 10 mg/day, 30 mg/day, 45 mg/day IMU-838, or placebo in the induction period (10 weeks).
Thereafter is either the maintenance phase, or an extended induction phase or the open-label extension phase.