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:

Sponsor: Boehringer Ingelheim
Protocol: 1368.0005
IP: spesolimab (IL36 iv/sc)

Contact: ibdstudies@amc.uva.nl

Status: CLOSED FOR RECRUITMENT

Study Acronym: BI1368.0005
Phase: 2/3
Design: double-blind, placebo-controlled, multicenter RCT
Aim: efficacy and safety study with BI 655130 in subjects with moderate to severe ulcerative colitis who have failed previous biologics therapy

Induction: 12 weeks iv treatment (300mg, 450mg, 1200mg, placebo 1:1:1:1 ratio)
Extension: roll over to open-label long-term extension study (BI1368.17) with either re-induction 1200mg q4w iv, or 300mg q12w or qq6w s.c. for approx. 7 years

Sponsor: Shire
Protocol: SHP-647-301
IP: ontamalimab (aMAbCAM subcutaneous)

Contact: ibdstudies@amc.uva.nl

Status: CLOSED FOR RECRUITMENT

Study Acronym: FIGARO
Phase: 3
Design: double-blind, placebo-controlled, parallel RCT
Aim: efficacy and safety study in subjects with moderate to severe ulcerative colitis.

Induction: 12 weeks treatment (25mg, 75mg, placebo 2:2:1 ratio)
Maintenance: 52 weeks after roll over to maintenance study (SHP647-303)
Extension: roll over to double-blind 25mg/75mg long-term extension study (SHP647-304)

Sponsor: Lilly
Protocol: I6T-MC-AMAN
IP: mirikizumab (IL23p19 iv/sc)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: LUCENT
Phase: 3
Design: multicenter, double-blind, parallel, placebo-controlled RCT
Aim: study of mirikizumab in conventional-failed and biologic-failed patients with moderately to severely active ulcerative colitis.

Induction: 12 weeks of mirikizumab 300mg versus placebo iv, ratio 3:1
Maintenance: roll over to 40-week maintenance study I6T-MC-AMBG 300mg mirikizumab sc
Extension: roll over to undefined long-term extension study I6T-MC-AMAP 300mg mirikizumab sc

Sponsor: AbbVie
Protocol: M16-067
IP: risankizumab (IL23p19 iv/sc)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITMENT on hold due to COVID-19

Study Acronym: INSPIRE
Phase: 2b/3
Design: double-blind, placebo-controlled, multicenter RCT
Aim: efficacy and safety of risankizumab 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

Sponsor: GSK
Protocol: 204869/01
IP: aLAG3 (GSK2831781)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: GSK204869
Phase: 2
Design: double-blind (sponser open) placebo-controlled RCT
Aim: safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis

Induction: 10 or 22 weeks (extended induction). Placebo, 45mg, 150mg, 300mg, 450mg IV
Maintenance phase: until week 30 (responders) of week 42 (non-responders). Placebo or 300mg SC Q4W
Open-label arm: Non-responders at week 10 receive GSK2831781 450mg IV

Follow up: 12 weeks

Sponsor: Immunic AG
Protocol: P2-IMU-838-UC
IP: IMU-838 (oral vidofludimus calcium)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: CALDOSE-1
Phase: 2
Design: double-blind placebo-controlled RCT
Aim: safety and efficacy of IMU-838 in moderate to severe UC

Induction: 10 or 22 weeks (extended induction). Placebo, 10mg, 30mg or 45mg.
Maintenance phase: until week 50 or UC relapse. Placebo, 10mg or 30mg.
Open-label arm: 30mg IMU-838

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

Contact: ibdstudies@amc.uva.nl

Status: CLOSED FOR RECRUITMENT

Study Acronym: BI1368.10
Phase: 2a
Design: multicenter, double-blind, parallel-group, placebo-controlled RCT.
Aim: add-on proof of concept study in patients with mild or moderate ulcerative colitis, who take a TNF inhibitor.

Treatment: 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.
Follow up: 3 months

Sponsor: Takeda
Protocol: Vedolizumab-4004
IP: vedolizumab iv

Contact: ibdstudies@amc.uva.nl

Status: Recruitment on hold

Study Acronym: EARNEST
Phase: 4
Design: double-blind, placebo-controlled RCT
Aim: efficacy and safety of entyvio (vedolizumab IV) in the treatment of chronic pouchitis

Treatment: 34 weeks (infusions at wk 0, 2, 6, 14, 22 and 30)
Follow up: 18 weeks
Total duration approximately 52 weeks

Sponsor: AbbVie
Protocol: M14-234
IP: upadacitinib (oral jak inhibitor)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: ACHIEVE
Phase: 2b/3
Design: multicenter, double-blind, placebo-controlled RCT.
Aim: study to evaluate the safety and efficacy of ABT-494 (upadacitinib) for induction and maintenance therapy in subjects with moderately to severely active ulcerative colitis.

Induction: 8 weeks (dose finding related substudies)
Maintenance: 44 weeks
Extension/open-label: subjects who do not achieve clinical response at week 8 will have the option to enroll into a separate AbbVie study (study M14-533) and receive open-label ABT-494 therapy

Sponsor: Celgene
Protocol: RPC01-3101
IP: ozanimod (oral S1P receptor)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

Study Acronym: TrueNorth
Phase: 3
Design: multicenter, double-blind, placebo-controlled RCT
Aim: oral RPC1063 as therapy for moderate to severe ulcerative colitis

Induction: 10-weeks
Maintenance:  42-week maintenance period
Extension/open-label: 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 (RPC01-3102).

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

Contact: ibdstudies@amc.uva.nl

Status: CLOSED

Study Acronym: SELECTION
Phase: 2a/3
Design: double-blind, placebo-controlled RCT
Aim: efficacy and safety of filgotinib in subjects with moderately to severely active ulcerative colitis

Induction: 10 weeks
Maintenance: 58 weeks
Extension: Long Term Extension study GS-US-418-3899
Dosing is 2:2:1 ratio to 1 of 3 treatments

Recruitment completed

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

Contact: ibdstudies@amc.uva.nl

Status: CLOSED

Study Acronym: GARDENIA
Phase: 3
Design: double-blind, placebo-controlled (4:1), multicenter RCT
Aim: 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

Recruitment completed.