CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Risankizumab 600 mg IV +1 moredrug
Likely dose
Risankizumab 600 mg IVfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02513459
NCT02513459Phase 2Completed
CompareCT.gov

An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

AbbVie·interventional·Posted Jul 31, 2015·Updated Apr 24, 2020

In Brief

A Phase 2 clinical trial evaluating Risankizumab 600 mg IV and Risankizumab 180 mg SC for Crohn Disease. Completed, enrolled 65 participants across 28 sites in 9 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesBelgium, Canada, Germany, Netherlands, Poland, South Korea, Spain, United Kingdom, United States
CollaboratorsBoehringer Ingelheim

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 31, 2015
Enrollment StartSep 16, 2015
Primary CompletionJun 19, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.9 years ago

Interventions

Risankizumab 600 mg IVdrug

Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained

Risankizumab 180 mg SCdrug

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.