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IMMhance

BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment 

    Status Active, not recruiting
    Related Conditions
    Psoriasis

Enrollment Details

507 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M15-992 (BI study 1311.4)

Brief summary

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This is a confirmatory, multicentre, randomized, double-blind, placebo controlled, 104 week study with a 88 week treatment period and a 16 week follow-up period evaluating the efficacy and safety of BI 655066 / ABBV-066 (risankizumab) to support Registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients. This study will also look at the maintenance of response following randomly withdrawing treatment from those patients responding to treatment at week 28, as well as the response to re-treatment for patients who relapse. This study will also assess PK and emergence of anti-drug antibodies as well as the influence of study treatment on disease specific markers. In a subset of psoriasis patients with concomitant psoriatic arthritis, the signs and symptoms of psoriatic arthritis will be evaluated to assess improvement. 

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

Canada: 9

0
Halifax, NS
1
North Bay, ON
2
Ottawa, ON
3
Peterborough, ON
4
Richmond Hill, ON
5
Toronto, ON
6
Waterloo, ON
7
Windsor, ON
8
Montreal, QC
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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. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly.
    • Age >=18 years at screening
    • Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) 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); Have an involved body surface area (BSA) >= 10% and Have a Psoriasis Area and Severity Index (PASI) >= 12 and Have a static Physician Global Assessment (sPGA) score of > = 3.
    • Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
    • Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with GCP and local legislation
    • Patients with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment.
    • Previous exposure to ABBV-066
    • Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study
    • Use of any restricted medication as noted 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
    • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
    • Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition 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 unable 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 enrollment in this trial