Recruiting studies for Crohn’s disease

The IBD clinical trial unit currently has several sponsor studies available for patients with Crohn’s disease.

The following studies are open for recruitment:

Sponsor: AbbVie Inc.
Protocol: M20-259
IP: risankizumab (iv/sc)

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is a Phase 3b, multicenter, randomized, efficacy assessor-blinded, parallel-group study to compare the efficacy and safety of risankizumab (IL23 p19 antibody) versus ustekinumab for the treatment of adult subjects with moderate to severe CD who have failed anti-TNF therapy.

The duration of the study will be approximately 73 weeks and will include a 35-day screening period, a 48-week treatment period, and a 140-day follow up visit/call after the last dose of study drug.

Subjects who meet eligibility criteria will be randomized 1:1 to 1200 mg induction dose of risankizumab intravenous (IV) administered at Baseline, Weeks 4 and 8.
At Week 12, all risankizumab subjects will be randomized in a 1:1 ratio to receive a risankizumab maintenance dose of 180 mg or 360 mg SC every 8 weeks, until the maintenance dose selection has been determined from the risankizumab CD maintenance study (Study M16-000).

Or subjects who meet eligibility criteria will be randomized 1:1 to ustekinumab weight-based IV induction dose at Baseline, then at Week 8 a 90 mg subcutaneous (SC) maintenance dose every 8 weeks as per the ustekinumab label.

Yellowstone
Sponsor: Celgene (BMS)
Protocol: celgene RPC01-3202
IP: Ozanimod (oral)

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is a Phase 3, randomized, double-blind, placebo-controlled study to determine the effect of oral ozanimod (S1P receptor modulator) as an induction treatment for subjects with moderately to severely active CD.

Subjects with active clinical symptoms and mucosal inflammation will be randomized in a 2:1 ratio to receive either ozanimod or placebo.

50% of subjects with a history of treatment with marketed biologic agents (eg, TNF antagonists, anti-IL-12/23 and anti-integrin therapy) will be recruited. And a similar proportion of subjects who have failed or been intolerant to corticosteroids or immunomodulators but never failed a biologic.

There is a 12 week Induction Study. Followed by either a Maintenance Study and/or Open-Label Extension Study.

U-Excel
Sponsor: AbbVie Inc.
Protocol: M14-433
IP: upadacitinib (oral)

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is a Phase 3, randomized, double-blind, placebo-controlled induction study to evaluate the efficacy and safety of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult subjects with moderately to severely active CD.

Subjects who consent and meet all of the inclusion criteria and none of the exclusion criteria will be enrolled into this study, which encompasses 2 parts: (Part 1) a randomized, double-blind, placebocontrolled induction; and (Part 2) an Extended Treatment Period for non-responders from Part 1.

Subjects will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily (QD) or matching placebo for 12 weeks.
Visits during the study will occur at Baseline and Weeks 2, 4, 8, and 12/Premature Discontinuation to collect clinical, endoscopic and laboratory assessments of disease activity.

At Week 12, subjects achieving clinical response may be eligible to enter the 52-week, double-blind, maintenance portion of Study M14-430.
All subjects who do not achieve clinical response at Week 12 will be eligible to participate in Part 2 (Extended Treatment Period) to receive double-blind upadacitinib until Week 24/PD.

GALAXI
Sponsor: Janssen Research & Development
Protocol: CNTO1959CRD3001
IP: Guselkumab (iv/sc)

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is phase 2/3 double-blind, placebo-controlled, multicenter RCT to evaluate the efficacy and safety of guselkumab (IL23 p19 antibody) in subjects with moderate to severe active Crohn’s disease.

Under this protocol, there are 3 separate studies:
a 48-week Phase 2 dose-ranging study (ie, GALAXI 1) and two identical 48-week Phase 3 confirmatory studies (ie, GALAXI 2 and GALAXI 3).

Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long-term extension (LTE [Week 48 to Week 156]) and receive approximately 2 additional years of treatment.

DIVERSITY
Sponsor: Gilead Sciences, Inc.
Protocol: GS-US-419-3895
IP: filgotinib (oral)

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is a Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib (JAK1) in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

Subjects are randomized in a 1:1:1 ratio to one of three treatment options: 200mg filgotinib, 100mg filgotinib or placebo.

The 10-week induction period, may be followed up to 58 weeks in the maintenance period. After week 58 a Long Term Extension study (GS-US-419-3896) is also available at our site.

Sponsor: Boehringer Ingelheim
Protocol: 1368-0008
IP: spesolimab (iv)

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is phase 2a multi-center, randomized, double-blind and placebo-controlled study testing the mechanism of action and clinical effect of BI 655130 (IL36R antibody) in patients with fistulizing Crohn’s diseas

Patients with previously treatment-resistant perianal fistulizing CD with clinical indication for seton drainage may opt for inclusion.

The Screening Cohort (4 weeks) will consist of:
– Screening period
– Fistula preparation and seton placement visit
– Follow-up period phase 2a

The Study Cohort will consist of:
– Screening period, including fistula preparation visits
– Period 1: 12-week blinded intravenous therapy period
– Period 2: 12-week blinded intravenous therapy period (treatment assignment depends on randomized treatment and achievement of combined perianal fistula remission after treatment period 1)
– Roll over into open label long-term extension study 1368-0007
OR 12-week safety follow up period for patients not rolling-over into open label longterm extension study.