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

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ClinicalTrials.gov Identifier: NCT02719171
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : September 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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: ABBV-066 Drug: Placebo for ABBV-066 Phase 2

Study Design

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/Risankizumabin Patients With Active Psoriatic Arthritis
Actual Study Start Date : April 2016
Primary Completion Date : May 2017
Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ABBV-066 high dose Drug: ABBV-066
Other Names:
  • BI 655066
  • risankizumab
Experimental: ABBV-066 medium high dose Drug: ABBV-066
Other Names:
  • BI 655066
  • risankizumab
Experimental: ABBV-066 medium dose Drug: ABBV-066
Other Names:
  • BI 655066
  • risankizumab
Experimental: ABBV-066 low dose Drug: ABBV-066
Other Names:
  • BI 655066
  • risankizumab
Placebo Comparator: Placebo Drug: Placebo for ABBV-066


Outcome Measures

Primary Outcome Measures :
  1. American College of Rheumatology (ACR) 20 response at Week 16 [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change in Tender Joint Count at Week 16 as compared to baseline [ Time Frame: 16 weeks ]
  2. Change in Swollen Joint Count at Week 16 as compared to baseline [ Time Frame: 16 weeks ]
  3. Change in Dactylitis Count at Week 16 as compared to baseline (in patients with dactylitis at baseline) [ Time Frame: 16 weeks ]
  4. American College of Rheumatology (ACR) 50 response at Week 16 [ Time Frame: 16 weeks ]
  5. American College of Rheumatology (ACR) 70 response at Week 16 [ Time Frame: 16 weeks ]
  6. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 as compared to baseline [ Time Frame: 16 weeks ]
  7. Change in Short Form-36 Health Survey (SF-36) at Week 16 as compared to baseline [ Time Frame: 16 weeks ]
  8. Change in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 16 as compared to baseline (in patients with enthesitis at baseline) [ Time Frame: 16 weeks ]
  9. Change in modified Nail Psoriasis Severity Index (mNAPSI) at Week 16 as compared to baseline (in patients with nail psoriasis) [ Time Frame: 16 weeks ]
  10. Psoriasis Area and Severity Index (PASI) 90 response at Week 16 assessed in patients with a >/= 3% baseline psoriasis Body Surface Area (BSA) [ Time Frame: 16 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 TNFi agents, as assessed by the investigator
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

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 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. 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 tuberculosis.
  • 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
Contacts and Locations

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


  Show 59 Study Locations
Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02719171     History of Changes
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
Last Update Posted: September 8, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases