BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Risankizumab; Placebo
Intervention description: Risankizumab administered by subcutaneous injection; Placebo for risankizumab administered by subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 507.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ABBV-066; BI 655066; risankizumab

Summary:

      This was a multinational, multicenter, randomized, double-blind, placebo controlled study
      with randomized withdrawal and retreatment, evaluating the safety and efficacy of
      risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female participants. 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 participant.

          -  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 Good Clinical Practice (GCP)
             and local legislation

        Exclusion criteria:

          -  Participants 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, human
             immunodeficiency virus (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 electrocardiogram [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 enrolment in this trial