BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: ABBV-066 Drug: ustekinumab Drug: placebo to ABBV-066 Drug: placebo to ustekinumab	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator, Outcomes Assessor Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Ustekinumab

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

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 Outcome Measures:

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 ]


Estimated Enrollment:	500
Actual Study Start Date:	February 2016
Estimated Study Completion Date:	September 2017
Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ABBV-066	Drug: ABBV-066 Other Name: BI 655066, risankizumab Drug: placebo to ustekinumab
Active Comparator: Ustekinumab	Drug: ustekinumab Drug: placebo to ABBV-066
Placebo Comparator: Placebo	Drug: placebo to ABBV-066 Drug: placebo to ustekinumab

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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®).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02684370

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Sponsors and Collaborators

AbbVie

Boehringer Ingelheim

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information


Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT02684370 History of Changes
Other Study ID Numbers:	M16-008 2014-005117-23 ( EudraCT Number ) 1311.3 ( Other Identifier: Boehringer Ingelheim )
Study First Received:	February 16, 2016
Last Updated:	April 17, 2017

Keywords provided by AbbVie:


Psoriasis Skin Diseases Skin Diseases, Papulosquamous ustekinumab	Dermatologic Agents ABBV-066 BI 655066 risankizumab

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases Ustekinumab Dermatologic Agents

ClinicalTrials.gov processed this record on July 17, 2017