Risankizumab vs Deucravacitinib for Psoriasis
(IMMpactful Trial)
Recruiting in Palo Alto (17 mi)
+69 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: AbbVie
No Placebo Group
Prior Safety Data
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.
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.
12345What 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.
13678Is 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.
356910Eligibility 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.
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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
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Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Center for Clinical StudiesHouston, TX
Center for Clinical StudiesWebster, TX
Investigate MD /ID# 263626Scottsdale, AZ
First OC Dermatology /ID# 263003Fountain Valley, CA
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, blocks cytokine signaling involved in psoriasis pathogenesis. This ethnic-bridging study evaluated deucravacitinib pharmacokinetics, tolerability, and safety in healthy Chinese subjects.
Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. [2022]Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis.
Deucravacitinib: First Approval. [2022]Deucravacitinib (SOTYKTU™) is a first-in-class, highly selective, oral tyrosine kinase 2 (TYK2) inhibitor. It acts via an allosteric mechanism, binding to the catalytically inactive pseudokinase regulatory domain of TYK2 and stabilizing an inhibitory interaction between the regulatory and catalytic domains. Deucravacitinib is being developed by Bristol Myers Squibb for the treatment of multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. It received its first approval (in the USA on 9 September 2022) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. On 26 September 2022, it was subsequently approved in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis. The Marketing Authorisation Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis has been validated in the EU, and clinical development of the drug for the treatment of multiple immune-mediated diseases is underway in numerous countries worldwide. This article summarizes the milestones in the development of deucravacitinib leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis. [2023]Deucravacitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, is approved in the United States to treat adults with moderate-to-severe plaque psoriasis (PsO). This study compared the long-term efficacy of deucravacitinib and adalimumab using results from long-term extension (LTE) trials.
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]Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor that demonstrated superior efficacy versus placebo and apremilast in a global phase 3 trial (POETYK PSO-1; NCT03624127) in patients with moderate to severe plaque psoriasis (N = 666). This report describes efficacy and safety in Japanese patients from this study (N = 66) who were randomly assigned to treatment with deucravacitinib 6 mg once daily (n = 32), placebo (n = 17), or apremilast 30 mg twice daily (n = 17). Patients randomized to placebo crossed over to deucravacitinib at Week 16. Patients randomized to apremilast who did not achieve ≥50% reduction from baseline in Psoriasis Area and Severity Index (PASI 50) score at Week 24 switched to deucravacitinib. The proportion of Japanese patients achieving ≥75% reduction from baseline in PASI (PASI 75) score was numerically higher with deucravacitinib versus placebo and apremilast at Week 16 (78.1% vs. 11.8% and 23.5%, respectively) and versus apremilast at Week 24 (78.1% vs. 29.4%). A numerically higher proportion of patients achieved a static Physician's Global Assessment score of 0 or 1 (clear or almost clear) with at least a two-point improvement from baseline (sPGA 0/1) with deucravacitinib versus placebo or apremilast at Week 16 (75.0% vs. 11.8% and 35.3%) and versus apremilast at Week 24 (75.0% vs. 29.4%). Findings for other clinical and patient-reported outcomes also favored deucravacitinib. Response rates were maintained through 52 weeks in the deucravacitinib group. Incidence rates for adverse events per 100 person-years (PY) in the Japanese patients were comparable across treatment groups through Week 52 (deucravacitinib, 336.8/100 PY; placebo, 321.0/100 PY; apremilast, 358.6/100 PY). The most frequently reported adverse event with deucravacitinib was nasopharyngitis. The efficacy and safety of deucravacitinib in Japanese patients was consistent with those in the global population in POETYK PSO-1.
SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]SOTYKTUTM (deucravacitinib) is a newly approved oral agent for managing moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is a highly selective allosteric tyrosine kinase 2 inhibitor targeting dysregulated cytokine responses in psoriasis patients. Its efficacy was demonstrated in two randomized, placebo- and active comparator-controlled phase 3 trials, where a significantly higher proportion of patients, up to 58.4% (194/332), achieved lessening of symptoms at week 16. The recommended dosing regimen of deucravacitinib is 6 mg once daily. More frequent adverse reactions occurring in the deucravacitinib-treated patients include upper respiratory infection (19.2% [161/840]), increase in blood creatine phosphokinase (2.7% [23/840]), herpes simplex infection (2.0% [17/840]), mouth ulcers (1.9% [16/840]), folliculitis (1.7% [14/840]), and acne (1.4% [12/840]). Continuance of treatment for up to week 52 did not increase the exposure-adjusted rates of adverse reactions. The selectivity and specificity of deucravacitinib treatment may improve its long-term safety profile, compared to other Janus kinase inhibitors.
First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. [2023]This randomized, double-blind, single- and multiple-ascending dose study assessed the pharmacokinetics (PKs), pharmacodynamics, and safety of deucravacitinib (Sotyktu™), a selective and potent small-molecule inhibitor of tyrosine kinase 2, in 100 (75 active, 25 placebo) healthy volunteers (NCT02534636). Deucravacitinib was rapidly absorbed, with a half-life of 8-15 h, and 1.4-1.9-fold accumulation after multiple dosing. Deucravacitinib inhibited interleukin (IL)-12/IL-18-induced interferon (IFN)γ production ex vivo in a dose- and concentration-dependent manner. Following in vivo challenge with IFNα-2a, deucravacitinib demonstrated dose-dependent inhibition of lymphocyte count decreases and expression of 53 IFN-regulated genes. There were no serious adverse events (AEs); the overall frequency of AEs was similar in the deucravacitinib (64%) and placebo (68%) groups. In this first-in-human study, deucravacitinib inhibited IL-12/IL-23 and type I IFN pathways in healthy volunteers, with favorable PK and safety profiles. Deucravacitinib is a promising therapeutic option for immune-mediated diseases, including Crohn's disease, psoriasis, psoriatic arthritis, and systemic lupus erythematosus.
Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis. [2023]The objective of this study was to review the safety and efficacy of deucravacitinib, a tyrosine kinase 2 (TYK2) inhibitor for moderate to severe plaque psoriasis.
Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. [2020]Risankizumab-rzaa (Skyrizi®; AbbVie) is a humanized IgG monoclonal antibody directed against interleukin-23p19 (IL-23p19) indicated for the treatment of moderate-to-severe psoriasis in adults who are candidates for systemic therapy or phototherapy. Four pivotal Phase III trials: UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent have demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis. This review highlights important findings from these and other clinical trials that have evaluated risankizumab. In addition, we discuss the mechanism of action, pharmacokinetics/pharmacodynamics, dosing recommendations, drug interactions, other potential indications, and ongoing clinical trials.
Risankizumab: A Review in Moderate to Severe Plaque Psoriasis. [2021]Risankizumab (Skyrizi®; risankizumab-rzaa) is a humanized immunoglobulin (Ig) G1 monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23, thereby inhibiting IL-23-dependent cell signaling. Subcutaneous risankizumab is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy (in the EU), those who are candidates for systemic therapy or phototherapy (in the USA) and those who have an inadequate response to conventional therapies (in Japan). In pivotal phase III trials (UltIMMa-1, UltIMMa-2, IMMvent and IMMhance), risankizumab was more effective than placebo, ustekinumab and adalimumab with regard to the proportion of patients achieving ≥ 90% improvement from baseline in Psoriasis Area and Severity Index score (PASI 90) and a static Physician's Global Assessment score of 0 or 1 at week 16, with these benefits maintained over the longer term. In supportive head-to-head trials, risankizumab was also superior to secukinumab and fumaric acid esters in terms of PASI 90 response rate. In an ongoing open-label extension study (LIMMitless), risankizumab was associated with durable and improved efficacy after switching from ustekinumab or adalimumab, as well as durable maintenance of efficacy through > 2.5 years of continuous exposure. Treatment with risankizumab improved health-related quality of life and was generally well tolerated, both in the short- and longer-term. In conclusion, risankizumab represents a useful new treatment option for patients with moderate to severe plaque psoriasis.