Risankizumab vs Deucravacitinib for Psoriasis
(IMMpactful Trial)
Trial Summary
What is the purpose of this trial?
Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly. This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participants Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) 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.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop certain medications. You must stop systemic immunomodulating treatments, systemic psoriasis treatments, and phototherapy at least 30 days before the trial. Topical treatments for psoriasis or other skin conditions must be stopped 14 days before the trial. Additionally, you cannot have taken strong cytochrome P450 enzyme inducers within 30 days or 5 half-lives before starting deucravacitinib.
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications before starting. You must not have taken systemic treatments like methotrexate or corticosteroids within 30 days before the trial, and topical treatments for psoriasis within 14 days before the trial.
What data supports the idea that Risankizumab vs Deucravacitinib for Psoriasis is an effective drug?
The available research shows that Deucravacitinib is effective for treating moderate to severe plaque psoriasis. In a study, 78.1% of Japanese patients taking Deucravacitinib achieved significant improvement in their condition compared to only 11.8% with a placebo and 23.5% with another drug called apremilast. This suggests that Deucravacitinib is more effective than some other treatments for psoriasis. However, there is no direct comparison with Risankizumab in the provided data.12345
What data supports the effectiveness of the drug Deucravacitinib for treating psoriasis?
Deucravacitinib has shown positive results in treating moderate to severe plaque psoriasis, with a significant number of patients achieving clear or almost clear skin in clinical trials. It has been approved in the USA and Japan for this condition, demonstrating its effectiveness in improving skin symptoms and quality of life for patients.12345
What safety data is available for Risankizumab and Deucravacitinib in treating psoriasis?
Deucravacitinib, also known as Sotyktu or BMS-986165, is a selective tyrosine kinase 2 inhibitor used for moderate to severe plaque psoriasis. Safety data from multiple studies indicate that common adverse reactions include upper respiratory infections, increased blood creatine phosphokinase, herpes simplex infections, mouth ulcers, folliculitis, and acne. No serious adverse events were reported, and the frequency of adverse events was similar to placebo in initial studies. Long-term safety appears favorable, with no increase in adverse reactions up to 52 weeks. Risankizumab, marketed as Skyrizi, is not specifically mentioned in the provided research, so no safety data is available from these sources.13678
What safety information is available for Deucravacitinib and Risankizumab in humans?
Deucravacitinib has been studied in healthy volunteers and patients with psoriasis, showing a favorable safety profile with no serious adverse events reported. Common side effects include upper respiratory infections, increased blood creatine phosphokinase, herpes simplex infections, mouth ulcers, folliculitis, and acne. Risankizumab's safety data is not provided in the available research articles.13678
Is the drug Deucravacitinib a promising treatment for psoriasis?
Yes, Deucravacitinib is a promising drug for treating psoriasis. It is a new, selective oral medication that has shown significant effectiveness in reducing psoriasis symptoms in clinical trials. Many patients experienced a noticeable improvement in their condition, and the drug has been approved for use in several countries. Its targeted approach may also offer a better long-term safety profile compared to other treatments.356910
How does the drug Risankizumab differ from Deucravacitinib for treating psoriasis?
Deucravacitinib is a unique oral medication that works by selectively inhibiting a specific enzyme (TYK2) involved in immune responses, while Risankizumab is an injectable drug that targets a different part of the immune system (IL-23) to reduce inflammation. This makes Deucravacitinib distinct as it offers an oral option with a novel mechanism compared to other treatments for psoriasis.356910
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for adults over 18 with moderate chronic plaque psoriasis for at least 6 months, who haven't tried biologic treatments. They should have a Psoriasis Area and Severity Index (PASI) score of ≥12, Body Surface Area (BSA) affected by psoriasis between 10% to 15%, and a moderate rating on the Static Physician Global Assessment (sPGA). It's not suitable for those well-managed by topicals or other therapies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period A
Participants receive either Risankizumab or Deucravacitinib. Risankizumab is administered as a single SC injection, and Deucravacitinib is taken orally once per day until Week 16.
Treatment Period B
Participants initially on Deucravacitinib may be re-randomized to receive Risankizumab or continue with Deucravacitinib. Risankizumab is administered at Weeks 16, 28, and 40, and Deucravacitinib is taken daily up to Week 52.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Deucravacitinib
- Risankizumab
Deucravacitinib is already approved in United States, European Union, Canada for the following indications:
- Moderate to severe plaque psoriasis
- Moderate to severe plaque psoriasis
- Moderate to severe plaque psoriasis
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