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

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ClinicalTrials.gov Identifier: NCT02684357
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE February 16, 2016
First Posted Date  ICMJE February 18, 2016
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index score (PASI 90) 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.
  • Achievement of a 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index 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 ]
Change History Complete list of historical versions of study NCT02684357 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Achievement of a static Physician Global Assessment (sPGA) score of clear at Week 16 (Risankizumab and Placebo) [ Time Frame: week 16 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  • Achievement of 100% reduction from baseline Psoriasis Area and Severity Index score (PASI 100) at Week 16 (Risankizumab and Placebo) [ 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.
  • Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 (Risankizumab and Placebo) [ Time Frame: week 16 ]
    The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.
  • Achievement of total score on the Psoriasis Symptom Diary (PSS) of 0 at week 16 (Risankizumab and Placebo) [ Time Frame: week 16 ]
    The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. Scores range from 0 (none) to 4 (very severe).
  • Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index score (PASI 90) at Week 16 (Risankizumab and Ustekinumab) [ 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.
  • Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16 (Risankizumab and Ustekinumab) [ Time Frame: week 16 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  • Achievement of 100% reduction from baseline Psoriasis Area and Severity Index score (PASI 100) at Week 16 (Risankizumab and Ustekinumab) [ 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.
  • Achievement of a static Physician Global Assessment (sPGA) score of clear at Week 16 (Risankizumab and Ustekinumab) [ Time Frame: week 16 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  • Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index score (PASI 90) at Week 52 (Risankizumab and Ustekinumab) [ 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.
  • Achievement of 100% reduction from baseline Psoriasis Area and Severity Index score (PASI 100) at Week 52 (Risankizumab and Ustekinumab) [ 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.
  • Achievement of a static Physician Global Assessment (sPGA) score of clear at Week 52 (Risankizumab and Ustekinumab) [ Time Frame: week 52 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  • Achievement of Psoriasis Area and Severity Index score 75% (PASI 75) at Week 12 (Risankizumab and Ustekinumab) [ Time Frame: week 12 ]
    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.
  • Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 12 (Risankizumab and Ustekinumab) [ Time Frame: week 12 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  • Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 (Risankizumab and Ustekinumab) [ Time Frame: week 16 ]
    The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.
  • Change from baseline in psoriasis symptoms evaluated using the total score on the Psoriasis Symptom Diary (PSS) at week 16 (Risankizumab and Ustekinumab) [ Time Frame: week 16 ]
    The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. Scores range from 0 (none) to 4 (very severe).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • 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 score (PASI 75) at Week 16 [ Time Frame: week 16 ]
  • Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 52 [ Time Frame: week 52 ]
  • Achievement of Psoriasis Area and Severity Index score 75% (PASI 75) at Week 52 [ Time Frame: week 52 ]
  • Achievement of >= 75% reduction from baseline Psoriasis Area and Severity Index 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 score (PASI 100) at Week 16 [ Time Frame: week 16 ]
  • Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index score (PASI 90) at Week 52 [ Time Frame: week 52 ]
  • Achievement of 100% reduction from baseline Psoriasis Area and Severity Index score (PASI 100) at Week 52 [ Time Frame: week 52 ]
  • Change from baseline in psoriasis symptoms evaluated using the total score on the Psoriasis Symptom Diary (PSS) at week 16 [ Time Frame: week 16 ]
  • Achievement of total score on the Psoriasis Symptom Diary (PSS) of 0 at week 16 [ Time Frame: week 16 ]
Current Other Pre-specified Outcome Measures
 (submitted: May 2, 2018)
  • Achievement of >= 75% reduction from baseline Psoriasis Area and Severity Index 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.
  • Achievement of a 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.
  • Achievement of Psoriasis Area and Severity Index score 75% (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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BI 655066 Compared to Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Official Title  ICMJE BI 655066 Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2 (UltIMMa-2)
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 to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: ABBV-066
    Other Names:
    • BI 655066
    • risankizumab
  • Drug: ustekinumab
  • Drug: placebo for ABBV-066
  • Drug: placebo for ustekinumab
Study Arms  ICMJE
  • Experimental: ABBV-066
    Interventions:
    • Drug: ABBV-066
    • Drug: placebo for ustekinumab
  • Active Comparator: Ustekinumab
    Interventions:
    • Drug: ustekinumab
    • Drug: placebo for ABBV-066
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: placebo for ABBV-066
    • Drug: placebo for ustekinumab
Publications * Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp KA, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes JM, Thompson EHZ, Bachelez H. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018 Aug 25;392(10148):650-661. doi: 10.1016/S0140-6736(18)31713-6. Epub 2018 Aug 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 16, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 are
    • not postmenopausal (12 months with no menses without an alternative medical cause) and are
    • 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):

    1. Have an involved body surface area (BSA) >= 10% and
    2. Have a Psoriasis Area and Severity Index (PASI) score >= 12 and
    3. 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.
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

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,
  • Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted),
  • Previous exposure to ustekinumab (Stelara®),
  • 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, aneurysm removal, stomach ligation),
  • Known chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis; QuantiFERON® TB test or PPD skin test will be performed according to local labelling for comparator products. 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 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 is 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 is pregnant, nursing, or who plans to become pregnant while in the trial,
  • Previous enrolment in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   France,   Germany,   Mexico,   Poland,   Portugal,   Spain,   United States
Removed Location Countries Italy,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT02684357
Other Study ID Numbers  ICMJE M15-995
2015-003622-13 ( EudraCT Number )
1311.28 ( Other Identifier: Boehringer Ingelheim )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Boehringer Ingelheim
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account AbbVie
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP