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Trial record 1 of 1 for:    NCT02694523
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BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02694523
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab 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 Biological: adalimumab Drug: placebo for ABBV-066 Biological: placebo for adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response (IMMvent)
Actual Study Start Date : March 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

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

Biological: placebo for adalimumab
Matching placebo for blinding purposes

Active Comparator: Adalimumab Biological: adalimumab
Other Name: Humira

Drug: placebo for ABBV-066
Matching placebo for blinding purposes




Primary Outcome Measures :
  1. Achievement of >=90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at Week 16 [ Time Frame: 16 weeks ]
    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 a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16 [ Time Frame: 16 weeks ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  3. Achievement of >=90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at Week 44 [ Time Frame: 44 weeks ]
    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.


Secondary Outcome Measures :
  1. Achievement of >=75% reduction from baseline PASI score (PASI 75) at Week 16 [ Time Frame: 16 weeks ]
    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 (PASI 100) at Week 16 [ Time Frame: 16 weeks ]
    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 100% reduction from baseline PASI score (PASI 100) at Week 44 for those patients who were re-randomized at Week 16 [ Time Frame: 44 weeks ]
    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.


Other Outcome Measures:
  1. Achievement of an sPGA score of clear or almost clear (0 or 1) at Week 44 for those patients who were re-randomized at Week 16 [ Time Frame: 44 weeks ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  2. Achievement of sPGA score of clear (0) at Week 44 for those patients who were re-randomized at Week 16 [ Time Frame: 44 weeks ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.



Information from the National Library of Medicine

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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. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

    *Women of childbearing potential are defined as:

    • having experienced menarche and
    • not postmenopausal (12 months with no menses without an alternative medical cause) and
    • not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
  • 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. 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) 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 candidates for treatment with adalimumab (Humira®) according to local label as confirmed by the investigator.
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

  • Patients with

    • non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
    • current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
    • active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment
  • Previous exposure to ABBV-066
  • Previous exposure to adalimumab (Humira®)
  • Currently enrolled in another investigational study or less than 30 days or more from screening since completing another investigational drug or device study.
  • Use of any restricted medication 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; QuantiFERON® TB test or PPD skin test will be performed according to local labelling for Humira®. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment should have been initiated and maintained according to local country guidelines.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) 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 unreliable 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): NCT02694523


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Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02694523     History of Changes
Other Study ID Numbers: M16-010
2015-003623-65 ( EudraCT Number )
1311.30 ( Other Identifier: Boehringer Ingelheim )
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by AbbVie:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
ABBV-066
BI 655066
Risankizumab

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents