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

NCT02719171 | Completed Phase 2 Results DMC

• 3 other identifiers: M16-0022015-003625-341311.5
• Study Type: interventional
• Target: 185
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 16

Secondary Outcomes (11)

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16

  Week 16

• Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16

  Week 16

• Tender Joint Count (TJC68): Change From Baseline to Week 16

  Baseline, Week 16

• Swollen Joint Count (SJC): Change From Baseline to Week 16

  Baseline, Week 16

• Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change From Baseline to Week 16

  Baseline, Week 16

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.

Drug: placebo for risankizumab

Risankizumab 150 mg Every 4 Weeks

EXPERIMENTAL

Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.

Drug: risankizumab

Risankizumab 150 mg Weeks 0, 4, and 16

EXPERIMENTAL

Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.

Drug: risankizumab

Risankizumab 150 mg Weeks 0 and 12

EXPERIMENTAL

Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.

Drug: risankizumab

Risankizumab 75 mg Week 0

EXPERIMENTAL

Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.

Drug: risankizumab

Interventions

risankizumab DRUG

Risankizumab administered by SC injection

Also known as: BI 655066, ABBV-066, SKYRIZI

Risankizumab 150 mg Every 4 Weeks; Risankizumab 150 mg Weeks 0 and 12; Risankizumab 150 mg Weeks 0, 4, and 16; Risankizumab 75 mg Week 0

placebo for risankizumab DRUG

Placebo for risankizumab administered by SC injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead
• Boehringer Ingelheim: collaborator

Related Publications (2)

• 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.

  PMID: 36178584 DERIVED

• 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.

  PMID: 35931879 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 25, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 30, 2019
• Results First Posted: May 30, 2019

Record last verified: 2019-05