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ClinicalTrial.gov Identifier : NCT02719171

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

    Status Completed
    Related Conditions
    Psoriatic Arthritis

Enrollment Details

185 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M16-002

Brief summary

Top

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.

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older

Canada: 4

0
Surrey, BC
1
St. John's, NL
2
Peterborough, ON
3
Waterloo, ON
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Double Blind (Subject, Investigator)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • 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

     

    • 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

     

More on this trial

ClinicalTrials.gov