CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 577 enrolled
Drug / intervention
risankizumab +3 moredrug
Likely dose
Not stated in 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/NCT02684357
NCT02684357Phase 3Completed
CompareCT.gov

BI 655066 Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2 (UltIMMa-2)

AbbVie·interventional·Posted Feb 18, 2016·Updated Aug 23, 2021

In Brief

A Phase 3 clinical trial evaluating risankizumab, ustekinumab, and 2 other interventions for Psoriasis. Completed, enrolled 577 participants.

Detailed Summary

This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
Countries--
CollaboratorsBoehringer Ingelheim

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 18, 2016
Enrollment StartMar 1, 2016
Primary CompletionDec 1, 2016
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago

Interventions

risankizumabdrug

Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

ustekinumabdrug

Ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection

placebo for risankizumabdrug

Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

placebo for ustekinumabdrug

Placebo for ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection