Recruiting studies for ulcerative colitis

The IBD Trial Unit currently has several sponsor studies available for patients with ulcerative colitis.
The following studies are open for recruitment:

INSPIRE
Sponsor: Abbvie
Protocol: M16-067
IP: risankizumab (iv/sc)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

To be continued

SELECTION
Sponsor: Gilead
Protocol: GS-US-418-3898
IP: Filgotinib (0ral JAK inhibitor)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Combined Phase IIb/III, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib (GS-6034) in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.

Subjects who are biologic-naïve and biologic-experienced will be enrolled in Cohorts A and B respectively.
After screening, the induction period will last 10 weeks, followed by a maintenance period up to 58 weeks. Subject can be enrolled in the Long Term Extension study GS-US-418-3899.
Dosing is 2:2:1 ratio to 1 of 3 treatments.

GSK
Sponsor: GlaxoSmithKline
Protocol: 202152
IP: GSK2982772 (oral RIP1 kinase inhibitor)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

A Phase II, multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects
with active ulcerative colitis.

Each subject will participate in the study for approximately 20 weeks. This includes a screening period up to 30 days, an 84 day (12 week) treatment period, and a 28 day follow-up period after the last dose.
Dosing is 2:1 ratio active GSK2982772 60 mg three times daily (TID) to placebo three times daily (TID).

BI1368.10
Sponsor: Boehringer Ingelheim
Protocol: BI1368.10
IP: BI 655130 (intravenous IL36)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

A Phase IIa multicenter, randomized, double-blind, parallel-group, placebo-controlled proof of concept study in patients with mild or moderate ulcerative colitis, who take a TNF inhibitor.

The study investigates whether bowel inflammation improves when patients take BI 655130 (1200mg  at week 0, 4 and 8) or placebo in addition to their current therapy. Duration of treatment 12 weeks with a follow up period.

ACHIEVE
Sponsor: Abbvie
Protocol: M14-234
IP: ABT-494 (oral jak inhibitor)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

A Phase IIb/III multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ABT-494 for induction and maintenance therapy in subjects with moderately to severely active ulcerative colitis.

TrueNorth
Sponsor: Receptos Inc.
Protocol: RPC01-3101
IP: RPC1063 (oral)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Phase III, multicenter, randomized, double-blind, placebo-controlled trial of oral RPC1063 for patients with moderate to severe ulcerative colitis.

This study contains a 10-week induction period and a 42-week maintenance period. Patients will be entered into the trial in 2 separate cohorts through induction period. Cohort 1 has a 2:1 ratio RPC1063 1mg or placebo. Cohort 2 is open-label RPC1063 1mg once daily.
Patients who complete the induction period without response at week 10 and those who complete the maintenance period and experience relapse, have the option to enter a separate open-label extension trial.

Main inclusion criteria
– UC extending more than 15cm disease activity on endoscopy
– MAYO score 6 to 12 (with endoscopic subscore 2 or more)
– Must receive and continue therapy with either oral aminosalicylates or oral prednisone (max 20mg/day) or budesonide MMX
– Positive VZV

Main exclusion criteria
– DM type 1, or uncontrolled DM type 2
– History of uveitis macular edema
– Cardiovascular conditions

GARDENIA
Sponsor: Roche
Protocol: GA29103
IP: etrolizumab (subcutaneous)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Phase III, double-blind, placebo-controlled (4:1), multicenter study of the efficacy and safety of etrolizumab during induction and maintenance in patients with moderate tom severe active ulcerative colitis who are refractory to or intolerant of TNF inhibitors.

Main inclusion criteria
– Active UC extending a minimum of 20 cm from the anal verge, intolerant or refractory to TNF-inhibitors within previous 5 years and no prior extensive colonic resection.