Deucravacitinib for Cutaneous Lupus Erythematosus

Recruiting at 102 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Must be taking: Oral corticosteroids, antimalarials, immunosuppressants

Disqualifiers: Pregnancy, Acute cutaneous lupus, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 56 weeks

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify that you need to stop your current medications. In fact, you need to be on a stable treatment for your condition, such as oral corticosteroids, antimalarials, or immunosuppressants, to participate.

What data supports the effectiveness of the drug Deucravacitinib for treating cutaneous lupus erythematosus?

Deucravacitinib has shown effectiveness in a phase II trial for systemic lupus erythematosus (SLE), a related condition, by acting as a selective inhibitor of TYK2, which is involved in immune system regulation. ^{1 2 3 4 5}

What safety data exists for Deucravacitinib in humans?

A study on Deucravacitinib for systemic lupus erythematosus (a condition affecting the immune system) evaluated its safety and found it to be generally safe for human use. ^{1 2 5 6 7}

How is the drug deucravacitinib different from other treatments for cutaneous lupus erythematosus?

Deucravacitinib is unique because it is an oral medication that selectively inhibits tyrosine kinase 2 (TYK2), a protein involved in immune system signaling, through an allosteric mechanism (binding in a way that changes the protein's shape). This makes it different from other treatments that may not target this specific pathway or use this method of action. ^{1 8 9 10 11}

What is the purpose of this trial?

This trial is testing a new medication called deucravacitinib to help people with certain types of lupus that aren't well managed by current treatments. The medication works by calming the immune system to reduce skin damage.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with active discoid or subacute cutaneous lupus erythematosus (DLE/SCLE) who have been diagnosed at least 3 months prior and are on a stable treatment regimen. It includes those with or without systemic lupus erythematosus (SLE), but excludes pregnant women, those with certain other autoimmune diseases, drug-induced CLE/SLE, severe neuropsychiatric SLE, or a history of multiple unexplained pregnancy losses.

Inclusion Criteria

I may or may not have lupus along with my current condition.

I have been diagnosed with DLE/SCLE for at least 3 months.

I am on a stable treatment plan for my skin condition with medication like corticosteroids, antimalarials, or immunosuppressants.

Exclusion Criteria

I have a specific type of skin lupus.

You have experienced three or more unexplained miscarriages in a row.

I have lupus caused by medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deucravacitinib or placebo to assess safety, efficacy, and tolerability

56 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Deucravacitinib
• Placebo

Trial Overview The study tests the safety and effectiveness of Deucravacitinib compared to a placebo in participants with moderate to severe DLE/SCLE that's not well-managed by current treatments. The goal is to see if Deucravacitinib can improve skin conditions in these patients.

Participant Groups

Group I: Active Treatment: Deucravacitinib Dose 2 Experimental Treatment 1 Intervention

Group II: Active Treatment: Deucravacitinib Dose 1 Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

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?

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

In a phase II trial involving 363 adults with active systemic lupus erythematosus (SLE), deucravacitinib significantly improved response rates compared to placebo, with 58% of patients on the 3 mg twice daily dose achieving the SLE Responder Index 4 (SRI-4) response at week 32.

The safety profile of deucravacitinib was generally acceptable, with similar rates of serious adverse events compared to placebo, although there were higher incidences of infections and skin-related issues like rash and acne in the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Morand, E., Pike, M., Merrill, JT., et al.[2023]

A new core outcome set (COS) for cutaneous lupus erythematosus (CLE) has been proposed, which includes essential domains like skin-specific disease activity, symptoms, and health-related quality of life, aimed at standardizing clinical trials and observational studies.

Recommended physician-reported measures for assessing disease activity include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and the Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA), although no single instrument was identified as superior for patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need. Guo, LN., Perez-Chada, LM., Borucki, R., et al.[2022]

In a study of 66 patients with cutaneous lupus erythematosus (CLE), the effectiveness of treatment outcomes varied significantly based on the thresholds used to measure improvement, highlighting the importance of selecting appropriate response criteria.

Factors influencing improvement in CLE activity and skin damage were identified, with older age at disease onset linked to better activity improvement, while certain demographics, like African-American race, were associated with poorer outcomes, emphasizing the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robust measurement of clinical improvement in patients with cutaneous lupus erythematosus. Nanes, BA., Zhu, JL., Chong, BF.[2022]

The EUSCLE Core Set Questionnaire was developed to standardize the evaluation of patients with cutaneous lupus erythematosus (CLE) across different European centers, facilitating consistent data collection and comparison.

This comprehensive tool includes six sections covering patient data, diagnosis, skin involvement, disease activity and damage, laboratory analysis, and treatment, which will help establish evidence-based clinical standards and guidelines for managing CLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Core Set Questionnaire by the European Society of Cutaneous Lupus Erythematosus (EUSCLE). Kuhn, A., Kuehn, E., Meuth, AM., et al.[2019]

Epratuzumab was found to be well-tolerated in a 12-week study involving 20 Japanese patients with moderate-to-severe systemic lupus erythematosus, with no new safety concerns identified and only two serious adverse events reported.

The treatment led to a decrease in CD22 expression on B cells and small-to-moderate reductions in total B cell counts, indicating its potential mechanism of action in modulating the immune response in lupus patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. Tsuru, T., Tanaka, Y., Kishimoto, M., et al.[2018]

In a study involving 38 patients with cutaneous lupus erythematosus (CLE), topical calcineurin inhibitors (tacrolimus and pimecrolimus) significantly improved clinical symptoms like erythema, desquamation, and edema over 60 days, whether used alone or with hydroxychloroquine.

The combination treatment with hydroxychloroquine led to a 100% improvement in edema among patients, while monotherapy with calcineurin inhibitors resulted in a 75% improvement, highlighting their effectiveness in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of topical calcineurin inhibitors as monotherapy or in combination with hydroxychloroquine in cutaneous lupus erythematosus. Avgerinou, G., Papafragkaki, DK., Nasiopoulou, A., et al.[2014]

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]

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 medication for moderate to severe plaque psoriasis, demonstrated higher PASI 75 response rates compared to apremilast and methotrexate across all time points in a network meta-analysis of 47 randomized controlled trials.

Long-term efficacy of deucravacitinib was comparable to first-generation biologics like adalimumab and ustekinumab, making it a viable oral treatment option for patients seeking effective psoriasis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. Armstrong, AW., Warren, RB., Zhong, Y., et al.[2023]

References

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

Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Robust measurement of clinical improvement in patients with cutaneous lupus erythematosus. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a Core Set Questionnaire by the European Society of Cutaneous Lupus Erythematosus (EUSCLE). [2019]

5. England pubmed.ncbi.nlm.nih.gov

Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. [2018]

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

Effectiveness of topical calcineurin inhibitors as monotherapy or in combination with hydroxychloroquine in cutaneous lupus erythematosus. [2014]

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

Deucravacitinib: First Approval. [2022]

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

Baricitinib for recalcitrant subacute cutaneous lupus erythematosus with concomitant frontal fibrosing alopecia. [2022]

11. 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]