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:

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

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: Yellowstone
Phase: 3
Design: double-blind, placebo-controlled, multicenter RCT
Aim: efficacy and safety of Upadacitinib in subjects with moderate to severe active Crohn’s disease

Induction: 12 weeks Ozanimod or placebo, ratio 2:1
Maintenance:
RPC01-3103 52 weeks maintenace study
RPC01-3104 up to 234 weeks open-label long-term extension study
Follow up: 90 days

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

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: U-EXCEED
Phase: 3
Design: double-blind, placebo-controlled, multicenter RCT
Aim: efficacy and safety of Upadacitinib in subjects with moderate to severe active Crohn’s disease

Induction: 12 weeks Upadacitinib 45 mg or Upadacitinib 30mg or placebo, ratio 1:1:1
Maintenance: roll over to study M14-430 for up tp 240 weeks with Upadacitinib 30mg QD or Upadacitinib 15mg QD or placebo
Follow up: 30 days

MOTIVATE
Sponsor: Abbvie
Protocol: M15-991
IP: risankizumab (IL23p19 iv/sc)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: MOTIVATE
Phase: 3
Design: double-blind, placebo-controlled, multicenter RCT
Aim: efficacy and safety of risankizumab in subjects with moderate to severe active Crohn’s disease

Induction: 12 weeks risankizumab 1200mg,  600mg or placebo IV, ratio 1:1:1
Maintenance: roll over to study M16-000 for up tp 300 weeks with open-label risankizumab 180 mg or 360mg SC every 8 weeks
Follow up: 140 days

GALAXI I
Sponsor: Janssen
Protocol: CNTO1959CRD3001
IP: Guselkumab (IV/SC)

Contact: ibdstudies@amc.uva.nl

Status: RECRUMENT on hold due to COVD-19

Study Acronym: GALAXI 1
Phase: 2/3
Design: double-blind, placebo-controlled, multicenter RCT
Aim: efficacy and safety of guselkumab in subjects with moderate to severe active Crohn’s disease

Induction: 12 weeks of guselkumab or placbo IV
Maintenance: up to 48 weeks guselkumab or placebo SC
Long-term extension: up to 140 weeks (to be followed)
Follow up: 16 weeks

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

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

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: BERGAMOT
Phase: 3
Design: multicenter, double-blind, placebo-controlled RCT
Aim: investigating the safety and efficacy of etrolizumab as an induction and maintenance treatment for patients with moderate to severe active Crohn’s disease

Induction: 14 weeks etrolizumab 210mg sc, 105mg sc or placebo, 1:2:2 ratio
Maintenance: 60 weeks etrolizumab 105mg or placebo sc q4w 1:1 ratio. A 12-week follow up period unless patients enroll in the open-label extension protocol JUNIPER GA29145

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

Contact: ibdstudies@amc.uva.nl

Status: CLOSED FOR RECRUITMENT

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