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

Phase 2CompletedNCT02719171

AbbVie185 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

185

Conditions

Arthritis, Psoriatic

Interventions

risankizumabDRUG

Risankizumab administered by SC injection

placebo for risankizumabDRUG

Placebo for risankizumab administered by SC injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 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.

Time frame: Week 16

Secondary Outcomes

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at 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.

Time frame: Week 16

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at 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.

Time frame: Week 16

Tender Joint Count (TJC68): Change From Baseline to 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.

Data from ClinicalTrials.gov

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