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

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AbbVie

Status and phase

Completed
Phase 2

Conditions

Arthritis, Psoriatic

Treatments

Drug: risankizumab
Drug: placebo for risankizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02719171
2015-003625-34 (EudraCT Number)
1311.5 (Other Identifier)
M16-002

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

185 participants in 5 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
Treatment:
Drug: placebo for risankizumab
Risankizumab 150 mg Every 4 Weeks
Experimental group
Description:
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
Treatment:
Drug: risankizumab
Risankizumab 150 mg Weeks 0, 4, and 16
Experimental group
Description:
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
Treatment:
Drug: risankizumab
Risankizumab 150 mg Weeks 0 and 12
Experimental group
Description:
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
Treatment:
Drug: risankizumab
Risankizumab 75 mg Week 0
Experimental group
Description:
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
Treatment:
Drug: risankizumab

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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