Deucravacitinib for Plaque Psoriasis

Recruiting in Palo Alto (17 mi)

+121 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Bristol-Myers Squibb

Disqualifiers: Other psoriasis, Recent infection, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Deucravacitinib safe for humans?

Deucravacitinib has been tested in clinical trials and is generally considered safe for humans. Common side effects include upper respiratory infections, increased blood enzyme levels, herpes simplex infections, mouth ulcers, and acne. No serious adverse events were reported in early studies, and its safety profile is favorable compared to other similar treatments. ^{1 2 3 4 5}

How is the drug Deucravacitinib unique for treating plaque psoriasis?

Deucravacitinib is unique because it is a first-in-class, highly selective oral drug that targets a specific enzyme called tyrosine kinase 2 (TYK2), which plays a role in the immune response involved in psoriasis. Unlike other treatments, it works by binding to a specific part of the enzyme to inhibit its activity, offering a new approach to managing moderate-to-severe plaque psoriasis. ^{1 2 6 7 8}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for kids and teens aged 4 to <18 with moderate to severe plaque psoriasis. They should be candidates for phototherapy or systemic therapy, have had psoriasis for at least 6 months, and not weigh less than the set limits. Those with other psoriasis types, recent infections, TB, or prior deucravacitinib use can't join.

Inclusion Criteria

My condition is moderate to severe.

I am between 12 and 18 years old for Cohort 1, or between 4 and 12 years old for Cohort 2.

I have finished 52 weeks of treatment in either Part A or B for a long-term study.

Exclusion Criteria

I have a type of psoriasis.

I have previously been treated with deucravacitinib.

I have had a recent infection.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A

Evaluation of drug levels of BMS-986165 to enable selection of 2 dose levels

Up to 6 weeks

Multiple visits (in-person)

Part B

Assessment of efficacy and safety of two dose levels in pediatric participants

Up to 16 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 66 weeks

Long-term extension (LTE)

Observation of long-term safety and tolerability of deucravacitinib

Up to 5 years

Treatment Details

Interventions

• Deucravacitinib (Janus Kinase (JAK) Inhibitor)

Trial Overview The study tests Deucravacitinib's levels and effectiveness in young patients with plaque psoriasis. It has two parts: Part A finds the right doses; Part B checks how well these doses work. There's also a long-term part that looks at safety over five years.

Participant Groups

Group I: Active treatment deucravacitinib standard dose Experimental Treatment 1 Intervention

Group II: Active treatment deucravacitinib half-standard dose Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Deucravacitinib is already approved in Canada for the following indications:

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

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.

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]

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]

Deucravacitinib is an oral small molecule that specifically inhibits TYK2, showing promising safety and efficacy for treating moderate to severe plaque psoriasis.

In phase III clinical trials, over 50% of patients taking deucravacitinib 6 mg daily achieved a significant reduction in psoriasis severity (≥75% improvement) at 16 weeks, compared to only 9-13% on placebo and 35-41% on another treatment, apremilast.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in moderate-to-severe psoriasis. Vu, A., Maloney, V., Gordon, KB.[2022]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Deucravacitinib in moderate-to-severe psoriasis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. [2022]