BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: risankizumab; adalimumab; placebo for risankizumab; placebo for adalimumab
Intervention description: Risankizumab administered by subcutaneous (SC) injection; Adalimumab pre-filled syringe, administered by subcutaneous (SC) injection; Placebo risankizumab administered by subcutaneous (SC) injection; Placebo for adalimumab pre-filled syringe, administered by subcutaneous (SC) injection
Intervention MeSH terms: Adalimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 684.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Skin Diseases; Skin Diseases, Papulosquamous; Adalimumab; Anti-Inflammatory Agents; ABBV-066; BI 655066; Risankizumab

Summary:

      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.
    

Eligibility criteria:

        Inclusion criteria:

          -  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):

               -  Have an involved body surface area (BSA) ≥ 10% and

               -  Have a Psoriasis Area and Severity Index (PASI) score ≥ 12 and

               -  Have a static Physician Global Assessment (sPGA) score of ≥ 3.

          -  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

        Exclusion criteria:

          -  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 (TB), human
             immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON® TB test or purified
             protein derivative (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 TB. If presence of latent TB 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 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 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