Clinical trial NCT02719171: BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Psoriatic
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2016-03-25
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16
timeFrame: Week 16
measure: Tender Joint Count (TJC68): Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Swollen Joint Count (SJC): Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Short Form-36 Health Status Survey (SF-36) Physical Component: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: SF-36 Mental Component: Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Dactylitis Count: Change From Baseline to Week 16 in Participants With Dactylitis at Baseline
timeFrame: Baseline, Week 16
measure: Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change From Baseline to Week 16 in Participants With Enthesitis at Baseline
timeFrame: Baseline, Week 16
measure: Modified Nail Psoriasis Severity Index (mNAPSI): Change From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.
citation: Mease PJ, Kellner H, Morita A, Kivitz AJ, Aslanyan S, Padula SJ, Topp AS, Eldred A, Behrens F, Papp KA. Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial. Rheumatol Ther. 2022 Oct;9(5):1361-1375. doi: 10.1007/s40744-022-00474-5. Epub 2022 Aug 5.