Overview

This trial is active, not recruiting.

Condition psoriasis
Treatments abbv-066, ustekinumab, placebo to abbv-066, placebo to ustekinumab
Phase phase 3
Target IL-12
Sponsor AbbVie
Collaborator Boehringer Ingelheim
Start date February 2016
End date December 2016
Trial size 500 participants
Trial identifier NCT02684370, 1311.3, 2014-005117-23, M16-008

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 BI 655066/ABBV-066 (risankizumab) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
abbv-066 BI 655066, risankizumab
placebo to ustekinumab
(Active Comparator)
ustekinumab
placebo to abbv-066
(Placebo Comparator)
placebo to abbv-066
placebo to ustekinumab

Primary Outcomes

Measure
Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at Week 16
time frame: week 16
Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16
time frame: week 16

Secondary Outcomes

Measure
Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16
time frame: week 16
Achievement of >= 75% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 75) at Week 12
time frame: week 12
Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 12
time frame: week 12
Achievement of 100% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 100) at Week 16
time frame: week 16
Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at Week 52
time frame: week 52
Achievement of 100% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 100) at Week 52
time frame: week 52
Change from baseline in psoriasis symptoms evaluated using the total score on the Psoriasis Symptoms Scale (PSS) at week 16
time frame: week 16
Achievement of total score on the Psoriasis Symptoms Scale (PSS) of 0 at week 16
time frame: week 16

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Male or female patients with age >= 18 years at screening. - Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. - Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation): - Have an involved body surface area (BSA) >= 10% and - Have a Psoriasis Area and Severity Index (PASI) score >= 12 and - Have a static Physician Global Assessment (sPGA) score of >= 3. - Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator. - Must be a candidate for treatment with Stelara® (ustekinumab) according to local label. Exclusion criteria: - Patients with: 1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular) 2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) 3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment - Previous exposure to BI 655066. - Previous exposure to ustekinumab (Stelara®).

Additional Information

Official title BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis (UltIMMa-1)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.