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About
This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.
Full description
Participants were randomized to receive either placebo, ustekinumab, or risankizumab in Part A. All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab or risankizumab in Part A continued to receive the same treatment (ustekinumab or risankizumab) in 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 International Council on Harmonisation (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 a candidate for treatment with Stelara® (ustekinumab) according to local label.
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practices (GCP) and local legislation
Exclusion criteria
Patients with:
Previous exposure to BI 655066,
Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted),
Previous exposure to ustekinumab (Stelara®),
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, aneurysm removal, stomach ligation),
Known chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis; QuantiFERON® tuberculosis (TB) test or purified protein derivative (PPD) skin test will be performed according to local labelling for comparator products. 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 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 is 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 is pregnant, nursing, or who plans to become pregnant while in the trial,
Previous enrolment in this trial.
Primary purpose
Allocation
Interventional model
Masking
577 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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