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

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ClinicalTrials.gov Identifier: NCT02684370
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: ABBV-066 Drug: ustekinumab Drug: placebo to ABBV-066 Drug: placebo to ustekinumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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)
Actual Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at Week 16 [ Time Frame: week 16 ]
  2. Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16 [ Time Frame: week 16 ]

Secondary Outcome Measures :
  1. Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 [ Time Frame: week 16 ]
  2. Achievement of >= 75% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 75) at Week 12 [ Time Frame: week 12 ]
  3. Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 12 [ Time Frame: week 12 ]
  4. Achievement of 100% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 100) at Week 16 [ Time Frame: week 16 ]
  5. Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at Week 52 [ Time Frame: week 52 ]
  6. Achievement of 100% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 100) at Week 52 [ Time Frame: week 52 ]
  7. Change from baseline in psoriasis symptoms evaluated using the total score on the Psoriasis Symptoms Scale (PSS) at week 16 [ Time Frame: week 16 ]
  8. Achievement of total score on the Psoriasis Symptoms Scale (PSS) of 0 at week 16 [ Time Frame: week 16 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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®).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684370


  Show 81 Study Locations
Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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 )
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: September 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