High Dose Risankizumab for Psoriasis
(KNOCKOUT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests higher doses of the drug risankizumab (also known as Skyrizi) to determine if it can more effectively clear plaque psoriasis, a skin condition that causes itchy, red patches. Researchers aim to discover how these doses affect specific immune cells in the skin. Participants will receive risankizumab injections at varying strengths to compare results. The trial seeks individuals who have had chronic plaque psoriasis for at least six months and have not found success with other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop taking topical medications for psoriasis 2 weeks before, oral medications for psoriasis 4 weeks before, and biologic medications for psoriasis (other than Risankizumab) 4 months before joining the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that risankizumab is generally safe for treating psoriasis. Studies have monitored patients using risankizumab for up to five years and found it well-tolerated, with no new safety issues. Common side effects include mild upper respiratory infections, headaches, tiredness, and injection site reactions, occurring in less than 1% of users. This study examines higher doses, but current evidence suggests risankizumab is safe for long-term use.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatments for psoriasis, which often involve topical applications or systemic therapies like methotrexate and cyclosporine, risankizumab targets a specific part of the immune system known as interleukin-23 (IL-23). This targeted approach can potentially lead to better control of the inflammatory process that causes psoriasis, with fewer side effects. Researchers are particularly excited about the high doses being tested — 300 mg and 600 mg — as they may offer more robust and quicker results compared to existing options. This could mean more effective relief for patients with moderate to severe psoriasis.
What evidence suggests that high-dose risankizumab might be an effective treatment for psoriasis?
Research shows that risankizumab effectively treats plaque psoriasis. Studies have found that a standard dose of 150 mg can significantly improve skin and reduce symptoms for many people. In this trial, participants will receive either a 300 mg or 600 mg dose of risankizumab. Previous studies demonstrated that these higher doses quickly reduce certain immune cells contributing to psoriasis. Additionally, risankizumab has kept skin clearer for longer periods. Overall, evidence supports its effectiveness, especially with higher doses.36789
Who Is on the Research Team?
Benjamin D Ehst, MD, PhD
Principal Investigator
Oregon Medical Research Center
Are You a Good Fit for This Trial?
This trial is for adults with chronic stable plaque psoriasis, having a body surface area (BSA) involvement of at least 10% and a Psoriasis Area Severity Index (PASI) score of 12 or more. Participants must be able to follow the study plan and women should use birth control if they can have children. People who've had certain treatments recently, those with other serious illnesses, drug or alcohol abuse history, suicidal behavior in the past six months, active infections like HIV or tuberculosis, pregnant or breastfeeding women cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive risankizumab subcutaneous injections at Weeks 0, 4, and 16 with either 300 mg or 600 mg doses
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at Weeks 28, 40, and 52
What Are the Treatments Tested in This Trial?
Interventions
- Risankizumab
Trial Overview
The study tests whether higher initial doses of risankizumab (300 mg and 600 mg) are more effective than standard doses at clearing skin by targeting immune cells called resident memory T cells in psoriatic lesions. The goal is to see if this leads to completely clear skin that lasts longer after stopping treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Risankizumab is already approved in Canada, United States, European Union for the following indications:
- Moderate-to-severe Crohn's disease
- Moderate-to-severe Crohn's disease
- Moderate-to-severe plaque psoriasis
- Moderate-to-severe Crohn's disease
- Moderate-to-severe plaque psoriasis
- Psoriatic arthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Medical Research Center
Lead Sponsor
AbbVie
Industry 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
Published Research Related to This Trial
Citations
NCT05283135 | High Dose Risankizumab for Psoriasis
This is a pilot study that explores whether higher initial doses of risankizumab (300 mg and 600 mg, 2 times and 4 times the standard initial doses for plaque ...
SKYRIZI® Efficacy In Moderate to Severe Plaque Psoriasis ...
The efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks.
Final LIMMitless Phase 3, Open-Label Extension Trial Results
In previous interim analyses of patients after 3 and 5 years of treatment, risankizumab 150 mg was well tolerated and demonstrated sustained and ...
Efficacy Data - SKYRIZI® (risankizumab-rzaa) for Crohn's
Results at 52 weeks are among 382 patients who achieved clinical response‡ after 12 weeks of treatment with SKYRIZI in induction trials. bContinuous placebo ...
High Risankizumab Induction Dose Rapidly Clears ...
Data from the phase 2 KNOCKOUT study show risankizumab's sustained benefit in reducing memory cells over 52 weeks in psoriasis patients.
Long-Term Safety of Risankizumab in Patients with ...
The results support the favourable safety profile of risankizumab for long-term treatment of psoriatic disease with no new safety concerns.
SAFETY PROFILE ESTABLISHED IN Ps AND PsA 1
Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea ...
Long-term safety and efficacy of risankizumab for the ...
Long-term continuous risankizumab treatment for up to 5 years was well tolerated and demonstrated high and durable efficacy.
Jun 12, 2020
Particularly, 66 percent of psoriasis patients receiving SKYRIZI achieved completely clear skin—100 percent clearance in the Psoriasis Area and ...
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