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BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719171
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic arthritis in order to select doses for further clinical trials.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: risankizumab Drug: placebo for risankizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Proof-of-concept, Dose-ranging Study of BI 655066/ABBV-066/Risankizumab in Patients With Active Psoriatic Arthritis
Actual Study Start Date : April 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
Drug: placebo for risankizumab
Placebo for risankizumab administered by SC injection

Experimental: Risankizumab 150 mg Every 4 Weeks
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
Drug: risankizumab
Risankizumab administered by SC injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI

Experimental: Risankizumab 150 mg Weeks 0, 4, and 16
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
Drug: risankizumab
Risankizumab administered by SC injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI

Experimental: Risankizumab 150 mg Weeks 0 and 12
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
Drug: risankizumab
Risankizumab administered by SC injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI

Experimental: Risankizumab 75 mg Week 0
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
Drug: risankizumab
Risankizumab administered by SC injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI




Primary Outcome Measures :
  1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16 [ Time Frame: Week 16 ]

    Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Patient assessment of pain
    • Patient global assessment of disease activity
    • Investigator's global assessment of disease activity
    • Health Assessment Questionnaire Disability Index (HAQ-DI)
    • Acute phase reactant value (C-reactive protein).

    Nonresponder imputation (NRI) was used for missing data.



Secondary Outcome Measures :
  1. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16 [ Time Frame: Week 16 ]

    Response defined by ACR50 criteria (improvement from baseline) at Week 16: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Patient assessment of pain
    • Patient global assessment of disease activity
    • Investigator's global assessment of disease activity
    • HAQ-DI
    • Acute phase reactant value (C-reactive protein).

    NRI was used for missing data.


  2. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16 [ Time Frame: Week 16 ]

    Response defined by ACR70 criteria (improvement from baseline) at Week 16: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters:

    • Patient assessment of pain
    • Patient global assessment of disease activity
    • Investigator's global assessment of disease activity
    • HAQ-DI
    • Acute phase reactant value (C-reactive protein).

    NRI was used for missing data.


  3. Tender Joint Count (TJC68): Change From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
    Sixty-eight joints were assessed and classified as either tender (1) or not tender (0). A negative change represents a decrease in the number of tender joints.

  4. Swollen Joint Count (SJC): Change From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
    Sixty-six joints were assessed and classified as either swollen (1) or not swollen (0). A negative change represents a decrease in the number of tender joints.

  5. Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
    The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. A negative change from Baseline indicates improvement.

  6. Short Form-36 Health Status Survey (SF-36) Physical Component: Change From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
    The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.

  7. SF-36 Mental Component: Change From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
    The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.

  8. Dactylitis Count: Change From Baseline to Week 16 in Participants With Dactylitis at Baseline [ Time Frame: Baseline, Week 16 ]
    The number of fingers and toes with dactylitis (ranging from 0 to 20). A negative change represents a decrease in the number of fingers and toes affected by dactylitis.

  9. Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change From Baseline to Week 16 in Participants With Enthesitis at Baseline [ Time Frame: Baseline, Week 16 ]
    Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was classified as either absent (0) or present (1) to yield total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (16 sites with tenderness). A negative change from Baseline indicates improvement.

  10. Modified Nail Psoriasis Severity Index (mNAPSI): Change From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
    mNAPSI grades each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail); pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (>50 pits present); nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling); and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. mNAPSI is calculated as the sum of all the components for all of the participants fingernails, for a minimal - maximal total score of 0 to 130. A negative change from Baseline indicates improvement.

  11. Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 [ Time Frame: Week 16 ]
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. The percentage of participants achieving PASI90 at Week 16 are provided. NRI was used for missing data.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  • Have psoriatic arthritis (PsA) symptoms for ≥ 6 months prior to screening, as assessed by the investigator
  • Have PsA on the basis of the Classification Criteria for Psoriatic Arthritis (CASPAR) with peripheral symptoms at screening visit, as assessed by the investigator
  • Have ≥ 5 tender joints and ≥ 5 swollen joints at screening and randomisation visits, as assessed by the investigator
  • At least one psoriasis (PsO) lesion or a documented personal history of PsO at screening, as assessed by the investigator
  • If patients receive concurrent PsA treatments, these need to be on stable doses
  • Active PsA that has been inadequately controlled by standard doses of non-steroidal anti-inflammatory drugs (NSAIDs) administered for ≥ 4 weeks, or traditional disease-modifying anti-rheumatic drugs (DMARDs) (including sulfasalazine) administered for ≥ 3 months, or tumor necrosis factor inhibitor (TNFi) agents, or subjects are intolerant to NSAIDs or DMARDs or tumor necrosis factor inhibitor (TNFi) agents, as assessed by the investigator

Exclusion criteria:

  • Major chronic inflammatory or connective tissue disease other than PsA (e.g. rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Lyme disease, gout) and fibromyalgia, as assessed by the investigator
  • Has received any therapeutic agent directly targeted to interleukin 12/23 (IL-12/23) (including ustekinumab), IL-23 or IL-17 (including secukinumab)
  • Prior use of more than two different TNFi agents
  • Use of the following treatments: TNFi agents within 12 weeks, etanercept within 8 weeks, leflunomide without cholestyramine wash-out within 8 weeks, systemic non-biologic medications for psoriatic arthritis or psoriasis and photochemotherapy within 4 weeks, intraarticular injections (including steroids) and intramuscular or intravenous corticosteroid treatment within 4 weeks, topical psoriasis medications and phototherapy within 2 weeks, low and high potency opioid analgesics within 2 weeks prior to randomisation
  • Plans for administration of live vaccines during the study period or within 6 weeks prior to randomisation
  • History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
  • Active systemic infections during the last 2 weeks (exception: common cold) prior to randomisation, as assessed by the investigator
  • Chronic or relevant acute infections including HIV, viral hepatitis and (or) active tuberculosis (TB). Patients with a positive QuantiFERON TB or purified protein derivate (PPD) test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB.
  • 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
  • Major surgery performed within 12 weeks prior to randomisation or planned within 32 weeks after randomisation (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator
  • Total white blood count (WBC) < 3,000/µL, or platelets < 100,000/µL or neutrophils < 1,500/µL, or hemoglobin < 8.5 g/dL at screening
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x the upper limit of normal, or serum direct bilirubin ≥ 1.5 mg/dL at screening
  • Positive rheumatoid factor or anti-cyclic-citrullinated peptide (anti-CCP) antibodies at screening

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): NCT02719171


Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] October 12, 2016
Statistical Analysis Plan  [PDF] October 16, 2017

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02719171    
Other Study ID Numbers: M16-002
2015-003625-34 ( EudraCT Number )
1311.5 ( Other Identifier: Boehringer Ingelheim )
First Posted: March 25, 2016    Key Record Dates
Results First Posted: May 30, 2019
Last Update Posted: May 30, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs