Risankizumab vs Deucravacitinib for Psoriasis

(IMMpactful Trial)

Not currently recruiting at 87 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: AbbVie

Must not be taking: Biologics, Immunomodulators

Disqualifiers: Other psoriasis, Severe renal insufficiency, Recent stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, risankizumab and deucravacitinib, for managing moderate chronic plaque psoriasis, a skin condition causing red, itchy patches. Participants will receive either injections of risankizumab or daily tablets of deucravacitinib (also known as Sotyktu) to determine which is more effective. It is open to individuals diagnosed with moderate chronic plaque psoriasis for at least six months who have not previously used biologic treatments. Regular visits to a clinic or hospital will monitor the effects and safety of the treatments. As a Phase 4 trial, this research focuses on understanding how these FDA-approved treatments can benefit more patients.

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 is the safety track record for these treatments?

Research shows that risankizumab is generally well-tolerated. Studies have found it effective for up to six years. Common side effects are usually mild, such as headaches, fatigue, and injection site reactions. Long-term use has not revealed any new safety concerns.

For deucravacitinib, studies indicate it remains safe over four to five years. Most people experience stable and predictable effects. No new safety issues have emerged, which is reassuring for long-term use. While specific common side effects weren't detailed in the sources, the absence of new concerns is a positive sign.

Both treatments have approval for psoriasis, which adds confidence in their safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Risankizumab and Deucravacitinib for psoriasis because they offer unique mechanisms of action compared to traditional treatments. Risankizumab is a biologic that targets the interleukin-23 (IL-23) pathway, which plays a crucial role in the inflammatory process of psoriasis, potentially offering more targeted relief. On the other hand, Deucravacitinib is an oral medication that inhibits TYK2, a protein involved in the signaling pathways of inflammatory processes, representing a novel approach to managing the condition. These treatments may offer new hope for patients who haven't responded well to standard options like topical therapies, phototherapy, or older biologics.

What evidence suggests that this trial's treatments could be effective for psoriasis?

In this trial, participants will receive either risankizumab or deucravacitinib to treat moderate to severe plaque psoriasis. Research has shown that risankizumab is highly effective, with most patients achieving 90% clearer skin after a year, and many achieving completely clear skin. Long-term studies also demonstrate its effectiveness for up to six years. Deucravacitinib has proven effective as well, with most patients seeing 75% clearer skin by Week 16. Its benefits persist over the long term, with consistent results for up to five years. Both treatments are well-researched and have demonstrated strong effectiveness in managing psoriasis symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib
• Risankizumab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Period B: Arm 2b Deucravacitinib Dose A Experimental Treatment 1 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 Treatment 1 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 A Experimental Treatment 1 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 A Experimental Treatment 1 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 A Experimental Treatment 1 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

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

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Risankizumab-rzaa (Skyrizi®) is an effective treatment for moderate-to-severe psoriasis, as demonstrated in four pivotal Phase III trials involving adult patients, showing both efficacy and safety.

The drug works by targeting interleukin-23p19 (IL-23p19), a key player in the inflammatory process of psoriasis, which helps reduce the symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. Reddy, V., Yang, EJ., Myers, B., et al.[2020]

In a phase 3 trial involving 66 Japanese patients with moderate to severe plaque psoriasis, deucravacitinib showed significantly higher efficacy compared to placebo and apremilast, with 78.1% of patients achieving a ≥75% reduction in PASI score at Week 16.

The safety profile of deucravacitinib was comparable to that of placebo and apremilast, with similar incidence rates of adverse events, and the most common side effect being nasopharyngitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Imafuku, S., Tada, Y., Hippeli, L., et al.[2023]

In a study involving 100 healthy volunteers, deucravacitinib was found to be rapidly absorbed with a half-life of 8-15 hours, showing a favorable pharmacokinetic profile and no serious adverse events, indicating good safety.

Deucravacitinib effectively inhibited key immune pathways (IL-12/IL-23 and type I IFN) in a dose-dependent manner, suggesting its potential as a therapeutic option for various immune-mediated diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. Catlett, IM., Aras, U., Hansen, L., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. Hoy, SM.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Jing, S., Lin, Y., Dockens, R., et al.[2023]

Deucravacitinib (SOTYKTUTM) is an effective oral treatment for moderate to severe plaque psoriasis, with up to 58.4% of patients showing symptom improvement by week 16 in phase 3 trials involving 840 participants.

The drug has a favorable safety profile, with common side effects like upper respiratory infections and herpes simplex infections occurring at manageable rates, and its selectivity may enhance long-term safety compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. Gupta, AK., Wang, T., Vincent, K., et al.[2023]

Deucravacitinib, an oral TYK2 inhibitor, demonstrated significant efficacy in treating moderate to severe plaque psoriasis, with 65.1% of patients achieving a PASI 75 response at week 16 across 6 clinical trials involving 2248 subjects.

The safety profile of deucravacitinib is favorable, with mild adverse events like nasopharyngitis being common, and serious adverse events occurring in only 1.35% to 9.5% of patients, making it a potentially less burdensome treatment option compared to injectable therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis. Truong, TM., Pathak, GN., Singal, A., et al.[2023]

Risankizumab is a monoclonal antibody that effectively targets IL-23, showing superior efficacy compared to placebo and other treatments like ustekinumab and adalimumab in pivotal phase III trials involving adults with moderate to severe plaque psoriasis.

In long-term studies, risankizumab demonstrated durable efficacy and improved quality of life for patients, with a favorable safety profile over more than 2.5 years of continuous treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: A Review in Moderate to Severe Plaque Psoriasis. Blair, HA.[2021]

In a long-term study involving 674 patients, deucravacitinib showed significantly higher efficacy than adalimumab, with 67.2% of patients achieving a 75% reduction in psoriasis severity (PASI 75) at 112 weeks compared to 54.0% for adalimumab.

Deucravacitinib maintained stable response rates over two years, while adalimumab's effectiveness declined, suggesting that deucravacitinib may offer a more consistent long-term treatment option for moderate-to-severe plaque psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis. Armstrong, AW., Park, SH., Patel, V., et al.[2023]

Citations

1. news.bms.com news.bms.com/news/details/2025/New-Five-Year-Sotyktu-deucravacitinib-Data-Show-Consistent-Safety-and-Durable-Response-Rates-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

New Five-Year Sotyktu (deucravacitinib) Data Show ... Clinical efficacy outcomes were sustained in patients who were continuously treated with Sotyktu for PASI 75 (72.1%, Year 1; 67.3%, Year 5) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40045918/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1l1vNBYu_ed6RIBx4yjiYJ-tnJX2DEnfLu2bT3RUcVLTGoG9AU&fc=None&ff=20250329043238&v=2.18.0.post9+e462414

Deucravacitinib in plaque psoriasis: Four-year safety and ... Deucravacitinib demonstrated a consistent safety profile and durable efficacy through 4 years of treatment in patients with moderate to severe plaque psoriasis.

3. sotyktu.com sotyktu.com/about-sotyktu/sotyktu-study-results

Moderate to Severe Plaque Psoriasis Study Results In one study, a majority of people taking SOTYKTU saw 75% CLEARER SKIN at Week 16 vs those taking placebo (53% vs 9%).

4. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2827130

Safety and Efficacy of Deucravacitinib in Moderate to ... The results of this analysis further support the long-term safety and efficacy of deucravacitinib for patients with moderate to severe plaque psoriasis.

5. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-Two-Late-Breaking-Presentations-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-Psoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/default.aspx

Corporate news details New data showed ACR20 responses (at least a 20 percent improvement in signs and symptoms of disease) achieved at Week 16 (Sotyktu, 54.2%; ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39602111/

An Open-Label Extension of Randomized Clinical Trials Efficacy outcomes included 75% or greater or 90% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static ...