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About
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.
Full description
This study consists of 2 parts (Part A and Part B).
Part A:
Part B:
Enrollment
Sex
Ages
Volunteers
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:
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
Exclusion criteria
Patients with
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
Primary purpose
Allocation
Interventional model
Masking
684 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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