A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

AbbVie

Status and phase: Completed; Phase 3; Phase 2

Conditions: Ulcerative Colitis (UC)

Treatments: Drug: risankizumab IV; Drug: placebo for risankizumab; Drug: risankizumab SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03398148

M16-067

2016-004677-40 (EudraCT Number)

Details and patient eligibility

About

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Enrollment: 1,558 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
• Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
• Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
• Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
• Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Exclusion criteria

• Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
• Participant receiving prohibited medications and treatment.
• Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
• Participant with currently known complications of UC (e.g., megacolon).
• No known active Coronavirus Disease - 2019 (COVID-19) infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,558 participants in 15 patient groups, including a placebo group

Substudy 1, Induction Period 1: Double-blind Placebo IV

Placebo Comparator group

Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Treatment:

Drug: placebo for risankizumab

Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV

Experimental group

Description:

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

Treatment:

Drug: risankizumab IV

Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV

Experimental group

Description:

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

Treatment:

Drug: risankizumab IV

Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV

Experimental group

Description:

Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.

Treatment:

Drug: risankizumab IV

Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV

Experimental group

Description:

Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.

Treatment:

Drug: risankizumab IV

Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC

Experimental group

Description:

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.

Treatment:

Drug: risankizumab SC

Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC

Experimental group

Description:

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.

Treatment:

Drug: risankizumab SC

Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV

Experimental group

Description:

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.

Treatment:

Drug: risankizumab IV

Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo

Experimental group

Description:

Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.

Treatment:

Drug: risankizumab IV

Substudy 2, Induction Period 1: Double-blind Placebo IV

Placebo Comparator group

Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Treatment:

Drug: placebo for risankizumab

Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV

Experimental group

Description:

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

Treatment:

Drug: risankizumab IV

Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC

Experimental group

Description:

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.

Treatment:

Drug: risankizumab SC

Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC

Experimental group

Description:

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.

Treatment:

Drug: risankizumab SC

Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV

Experimental group

Description:

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.

Treatment:

Drug: risankizumab IV

Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo

Experimental group

Description:

Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.

Treatment:

Drug: risankizumab IV