Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.

Sponsor
AbbVie
Study ID
NCT02031276
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • risankizumab IV — DRUG
    risankizumab administered by IV infusion
  • risankizumab SC — DRUG
    risankizumab administered by SC injection
  • Placebo — DRUG
    Placebo for risankizumab administered by IV infusion

Study Details

This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease.

Key Dates

Start date
Feb 28, 2014
Status verified
Oct 2018
Primary completion
Dec 31, 2015
Completion
Nov 30, 2016

Study Design

Enrollment
121 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Double-blind Placebo IV
    Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
  • Experimental: Double-blind Risankizumab 200 mg IV
    Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
  • Experimental: Double-blind Risankizumab 600 mg IV
    Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission at Week 12 [ Time Frame: Week 12 ]

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