Subcutaneous Risankizumab for Psoriasis
(UnlIMMited Trial)
Trial Summary
What is the purpose of this trial?
Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored. Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally. The study will be broken up into 2 sub-studies by disease location, participants with moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study S). In both sub-studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Risankizumab for treating psoriasis?
Research shows that Risankizumab is effective for moderate to severe plaque psoriasis, with many patients experiencing significant improvement in their skin condition. It was more effective than other treatments like placebo, ustekinumab, and adalimumab in clinical trials, and it helped improve patients' quality of life.12345
Is risankizumab safe for humans?
How does the drug risankizumab differ from other treatments for psoriasis?
Risankizumab is unique because it specifically targets the p19 subunit of interleukin-23 (IL-23), a protein involved in inflammation, and is administered as a subcutaneous injection every 12 weeks after initial doses. This makes it different from other treatments that may target different proteins or require more frequent dosing.356710
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
Adults with a 6-month history of chronic plaque psoriasis, including those with psoriatic arthritis, can join. They must have moderate to severe genital or scalp psoriasis that hasn't responded well to other treatments and are candidates for systemic therapy or phototherapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous injections of risankizumab or placebo during the treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo for Risankizumab
- Risankizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois