Recruiting studies for Crohn’s disease

The IBD Trial Unit currently has several sponsor studies available for patients with Crohn’s disease.
The following studies are open for recruitment:

U-exceed / U-excel
Sponsor: Abbvie
Protocol: M14-431 / M14-433
IP: upadacitinib (oral)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

To be continued

MOTIVATE / ADVANCE
Sponsor: Abbvie
Protocol: M15-991 / M16-006
IP: risankizumab (iv/sc)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

To be continued

DIVERSITY
Sponsor: Gilead
Protocol: GS-US-419-3895
IP: filgotinib (oral)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Combined Phase III, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

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

STARDUST
Sponsor: Janssen
Protocol: CNTO1275CRD3005
IP: ustekinemab (intravenous, subcutaneous)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Phase IIIb study of treat to target versus routine care maintenance strategies in Crohn’s disease patients treated with ustekinemab.

The study includes a 5-week screening period, a 8-week induction period, and a maintenance period up to week 48. Non-responder at week 8 leave the study. Responders are randomized to either the routine care arm or the treat to target arm where their treatment intervals can be shortened to 8-weekly or 4-weekly dosing.

Main inclusion criteria
– Active moderate to severe Crohn’s disease defined by CDAI between 220-450.
– Have received treatment with conventional therapy or one previous biologic agent approved for the treatment of Crohn’s disease

Main exclusion criteria
– Crohn’s disease complications such as strictures, stenoses, fistulizing disease or abdominal/perianal abscesses
– Previous exposure to IL-23 or IL-12

BERGAMOT
Sponsor: Roche
Protocol: GA29144
IP: etrolizumab (subcutaneous)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Phase III multicenter, randomized, double-blind, placebo-controlled trial, investigating the safety and efficacy of etrolizumab as an induction and maintenance treatment for patients with moderate to severe active Crohn’s disease.

The study design contains a 28-day screening period, a 14-week induction phase followed by a 60-week maintenance phase, and a 12-week follow up period unless patients enroll in the open-label extension protocol JUNIPER GA29145. Eligible patients will be randomized into one of three cohorts. Patients receiving etrolizumab in the induction phase who achieve a CDAI-70 response at week 14 will be randomized into the maintenance phase. Eligibility  to enroll into OLE involves completing the induction phase without clinical response, patients that experience disease worsening, patients with clinical relapse during maintenance phase and patients completing the maintenance phase.

Main inclusion criteria
– Crohn’s disease diagnosis 3 or more months before screening
– CDAI score between 220 and 480
– SES-score of 7 or higher (4 or higher when disease is only  limited to the ileum)
– Inadequate response or intolerance within 5 years of screening for corticosteroids, or immunosuppresants, or anti-TNF therapy

Main exclusion criteria
– Previous exposure to etrolizumab, vedolizumab, natalizumab and efalizumab
– Biologic therapy use within 12 weeks prior to baseline
– Stable doses for ongoing treatment with immunosuppresants
– Corticosteroid use higher than 20mg/day prednisone
– Subject who has had a surgical bowel resections, subjects with ostomy, pouch or bowel strictures, abcesses or fistulizing disease