393 Participants Needed

Risankizumab vs Deucravacitinib for Psoriasis

(IMMpactful Trial)

Recruiting at 69 trial locations
AC
Overseen ByABBVIE CALL CENTER
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

AI

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

I am considered suitable for drug treatment for my condition.
My psoriasis is not well-managed with current treatments.
I have been diagnosed with chronic plaque psoriasis for at least 6 months.
See 1 more

Exclusion Criteria

Participants who received any live viral or bacterial vaccine within 4 weeks prior to the first dose of study drug, or expect the need for live vaccination during study participation
Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO)
Participants with a history of current drug-induced PsO or a drug-induced exacerbation of preexisting PsO
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

16 weeks
Weekly and monthly visits

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.

36 weeks
Regular visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Deucravacitinib
  • Risankizumab
Trial OverviewThe study compares Risankizumab, given as an injection every 12 weeks, against Deucravacitinib taken orally daily in patients with plaque psoriasis. This Phase 4 trial is open-label and assesses the safety and effectiveness of these approved treatments through regular medical assessments.
Participant Groups
5Treatment groups
Experimental Treatment
Group I: Period B: Arm 2b Deucravacitinib Dose AExperimental Treatment1 Intervention
Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Deucravacitinib orally once per day up to Week 52
Group II: Period B: Arm 2a Risankizumab Dose A (Continued)Experimental Treatment1 Intervention
Participants initially randomized to risankizumab (Arm 1) will continue to receive risankizumab as a single SC injection at Weeks 16, 28, and 40
Group III: Period B: Arm 2a Risankizumab Dose AExperimental Treatment1 Intervention
Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Risankizumab as a single SC injection at Weeks 16, 20, 32, and 44
Group IV: Period A: Arm 2 Deucravacitinib Dose AExperimental Treatment1 Intervention
Participants will be centrally randomized at the Baseline (Day 1) visit to receive Deucravacitinib orally once per day until the day prior to Week 16
Group V: Period A: Arm 1 Risankizumab Dose AExperimental Treatment1 Intervention
Participants will be centrally randomized at the Baseline (Day 1) visit to receive Risankizumab as a single SC injection

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Sotyktu for:
  • Moderate to severe plaque psoriasis
🇪🇺
Approved in European Union as Sotyktu for:
  • Moderate to severe plaque psoriasis
🇨🇦
Approved in Canada as Sotyktu for:
  • Moderate to severe plaque psoriasis

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

Deucravacitinib, a selective tyrosine kinase 2 inhibitor, was found to be safe and well tolerated in a study involving 40 healthy Chinese subjects, with no serious adverse events reported.
The drug showed rapid absorption and a dose-dependent increase in systemic exposure, indicating that it effectively reaches the bloodstream and maintains consistent pharmacokinetics across different doses.
Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects.Jing, S., Lin, Y., Dockens, R., et al.[2023]
Deucravacitinib, an oral tyrosine kinase 2 inhibitor, showed significant improvements in psoriasis symptoms and quality of life as early as Week 4 in a 12-week Phase 2 trial involving adults with moderate to severe plaque psoriasis.
Patients experienced better quality of life alongside clinical improvements, indicating that as psoriasis symptoms improved, so did their overall well-being, suggesting that deucravacitinib could be a promising new treatment option.
Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial.Thaçi, D., Strober, B., Gordon, KB., et al.[2022]
Deucravacitinib is a first-in-class oral TYK2 inhibitor that works by stabilizing an inhibitory interaction within the TYK2 enzyme, which is important for treating various immune-mediated diseases.
It received its first approval in the USA on September 9, 2022, for adults with moderate-to-severe plaque psoriasis, and has since been approved in Japan for multiple forms of psoriasis, indicating its efficacy and safety in managing these conditions.
Deucravacitinib: First Approval.Hoy, SM.[2022]

References

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]
Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. [2022]
Deucravacitinib: First Approval. [2022]
Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis. [2023]
Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial. [2023]
SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]
First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. [2023]
Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis. [2023]
Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. [2020]
Risankizumab: A Review in Moderate to Severe Plaque Psoriasis. [2021]