A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in Chevy Chase, Maryland.

Sponsor
AbbVie
Study ID
NCT02513459
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Risankizumab 600 mg IV — DRUG
    Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained
  • Risankizumab 180 mg SC — DRUG
    Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.

Study Details

The primary objective of the study was to investigate long-term safety of risankizumab (BI 655066/ABBV-066) in participants with moderately to severely active Crohn's disease who showed a clinical response or remission on previous treatment with risankizumab in Study NCT02031276 (BI trial 1311.6/ AbbVie M15-993) and were now receiving long-term treatment. Additional objectives of this study were to further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of risankizumab.

Key Dates

Start date
Sep 16, 2015
Status verified
Apr 2020
Primary completion
Jun 19, 2019
Completion
Jun 19, 2019

Study Design

Enrollment
65 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Risankizumab
    Maintenance treatment with risankizumab 180 mg administered subcutaneously (SC) every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From the time of study drug administration until 140 days after the last dose of study drug in the current study or until the first dose of study drug in NCT03105102 (AbbVie M16-000 Sub-study 3), up to 4 years for participants who rolled-over ]

Locations (2)

FacilityCityStateZIPSite coordinators
MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068Chevy ChaseMaryland20815-
Clin Res Inst of Michigan, LLC /ID# 155066ChesterfieldMichigan48047-

Find similar trials in Chevy Chase, MD

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
MGG Group, Inc.Chevy Chase Clinical Research· Chevy Chase, MDClin Res Inst of Michigan, LLC· Chesterfield, MI

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