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IMMvent

BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis 

    Status Active, not recruiting
    Related Conditions
    Psoriasis

Enrollment Details

605 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M16-010 (BI study 1311.30)

Brief summary

Top

This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

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

    • Male or female patients. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
    • Women of childbearing potential are defined as:
      • having experienced menarche and
      • not postmenopausal (12 months with no menses without an alternative medical cause) and
      • not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
    • Age >= 18 years at screening
    • Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
    • Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization):
    • Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
    • Must be candidates for treatment with adalimumab (Humira®) according to local label as confirmed by the investigator.
    • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
    • Patients with
      • non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
      • current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
      • active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment
    • Previous exposure to ABBV-066
    • Previous exposure to adalimumab (Humira®)
    • Currently enrolled in another investigational study or less than 30 days or more from screening since completing another investigational drug or device study.
    • Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study.
    • Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation).
    • Known chronic or relevant acute infections, such as active tuberculosis, HIV or viral hepatitis; QuantiFERON® TB test or PPD skin test will be performed according to local labelling for Humira®. If the result is positive, patients 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. If presence of latent tuberculosis is established, then treatment should have been initiated and maintained according to local country guidelines.
    • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
    • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value at the Screening Visit outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
    • History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
    • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
    • Previous enrolment in this trial