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BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

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ClinicalTrials.gov Identifier: NCT02672852
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a confirmatory, multicentre, randomized, double-blind, placebo controlled, 104 week study with a 88 week treatment period and a 16 week follow-up period evaluating the efficacy and safety of BI 655066 / ABBV-066 (risankizumab) to support Registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients. This study will also look at the maintenance of response following randomly withdrawing treatment from those patients responding to treatment at week 28, as well as the response to re-treatment for patients who relapse. This study will also assess PK and emergence of anti-drug antibodies as well as the influence of study treatment on disease specific markers. In a subset of psoriasis patients with concomitant psoriatic arthritis, the signs and symptoms of psoriatic arthritis will be evaluated to assess improvement.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: ABBV-066 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
Actual Study Start Date : February 29, 2016
Actual Primary Completion Date : August 2, 2017
Actual Study Completion Date : July 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: ABBV-066 Drug: ABBV-066
ABBV-066 administered by subcutaneous injection
Other Names:
  • BI 655066
  • risankizumab

Placebo Comparator: Placebo Drug: Placebo
Placebo for ABBV-066 administered by subcutaneous injection




Primary Outcome Measures :
  1. Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI90) at week 16 [ Time Frame: week 16 ]
    PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  2. Achievement of an static Physician Global Assessment (sPGA) score of clear or almost clear at week 16 [ Time Frame: Week 16 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  3. Achievement of an static Physician Global Assessment (sPGA) score of clear or almost clear at week 52 [ Time Frame: Week 52 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.


Secondary Outcome Measures :
  1. Achievement of a 75% reduction from baseline PASI score (PASI 75) at week 16 [ Time Frame: Week 16 ]
    PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  2. Achievement of 100% reduction from baseline PASI score (PASI100) at week 16 [ Time Frame: Week 16 ]
    PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  3. Achievement of an sPGA score of clear(0) at Week 16 [ Time Frame: Week 16 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  4. Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 [ Time Frame: Week 16 ]
    The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.

  5. Achievement of an sPGA score of clear (0) or almost clear (1) at Week 104 [ Time Frame: Week 52 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.


Other Outcome Measures:
  1. Achievement of PASI 75 at Week 52 [ Time Frame: Week 52 ]
    PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  2. Achievement of PASI 90 at Week 52 [ Time Frame: Week 52 ]
    PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  3. Achievement of PASI 100 at Week 52 [ Time Frame: Week 52 ]
    PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.



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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. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly.
  • Age >=18 years at screening
  • Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
  • Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) >= 10% and Have a Psoriasis Area and Severity Index (PASI) >= 12 and Have a static Physician Global Assessment (sPGA) score of > = 3.
  • Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
  • Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with GCP and local legislation

Exclusion criteria:

  • Patients with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment.
  • Previous exposure to ABBV-066
  • Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study
  • Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study.
  • Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation,).
  • Known chronic or relevant acute infections such as active tuberculosis, HIV, or viral hepatitis
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
  • Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value at the screening visit outside the reference range that in the opinion of the Investigator, is clinically significant and would make the study participant unable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
  • History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Previous enrolment in this trial

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): NCT02672852


  Show 63 Study Locations
Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02672852     History of Changes
Other Study ID Numbers: M15-992
2014-005102-38 ( EudraCT Number )
1311.4 ( Other Identifier: Boehringer Ingelheim )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Keywords provided by AbbVie:
ABBV-066
BI 655066
risankizumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases