Deucravacitinib for Cutaneous Lupus Erythematosus

Not currently recruiting at 106 trial locations
Rs
Fl
BS
Overseen ByBMS 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
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of deucravacitinib for individuals with cutaneous lupus erythematosus (CLE). The focus is on moderate to severe forms of this condition, specifically discoid and subacute types, which may not respond well to standard treatments. Participants will receive either the new medication or a placebo (a harmless pill with no active drug) to compare results. Suitable candidates have managed CLE for over three months and are on stable doses of medications like steroids or immunosuppressants. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that deucravacitinib is likely to be safe for humans?

Research has shown that deucravacitinib is generally well-tolerated by patients. In a study on its use for skin conditions like cutaneous lupus erythematosus, the most common side effects were mild to moderate, including colds, headaches, and acne. Another study found that deucravacitinib was safer compared to other treatments. These findings suggest that while some side effects may occur, they are usually manageable. Ongoing research aims to better understand its safety.12345

Why do researchers think this study treatment might be promising for lupus?

Deucravacitinib is unique because it targets a novel pathway in the immune system, specifically inhibiting the TYK2 enzyme. This is different from standard treatments for cutaneous lupus erythematosus, which often involve broad immunosuppressants like corticosteroids or antimalarials. By focusing on a specific part of the immune response, deucravacitinib has the potential to effectively reduce symptoms with potentially fewer side effects. Researchers are excited about this treatment because it represents a more targeted approach, which could lead to better outcomes for patients managing this challenging condition.

What evidence suggests that deucravacitinib might be an effective treatment for cutaneous lupus erythematosus?

Research has shown that deucravacitinib may help treat cutaneous lupus erythematosus (CLE), including discoid and subacute types. A review found it more effective and safer than many other CLE treatments. In some studies, patients experienced major improvements or even a clearing of their skin symptoms. Additionally, trials for related conditions like systemic lupus erythematosus (SLE) demonstrated that deucravacitinib can work well. This trial will test deucravacitinib at two different doses against a placebo to evaluate its effectiveness for people with moderate to severe CLE.12346

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 am on a stable treatment plan for my skin condition with medication like corticosteroids, antimalarials, or immunosuppressants.
I have been diagnosed with DLE/SCLE for at least 3 months.
See 2 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment: Deucravacitinib Dose 2Experimental Treatment1 Intervention
Group II: Active Treatment: Deucravacitinib Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

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

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Approved in United States as Sotyktu for:
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Approved in European Union as Sotyktu for:
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Approved in Canada as Sotyktu for:

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Published Research Related to This Trial

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

Citations

Corporate news detailsNew data from the pivotal Phase 3 POETYK PsA-1 trial demonstrated that Sotyktu improved and maintained meaningful clinical responses, ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39694128/
A systematic review and meta-analysisDeucravacitinib shows superior efficacy and safety in cutaneous lupus erythematosus compared to various biologics and small molecules - A ...
NCT05620407 | A Study to Evaluate Effectiveness and ...The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus ...
61462 Efficacy and Safety of Deucravacitinib for ...Deucravacitinib led to significant improvement or remission of CLE in all studies, with 1 case report and one RCT reporting objective Cutaneous Lupus ...
A Study to Evaluate Efficacy and Safety of Deucravacitinib in ...The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in ...
Deucravacitinib shows superior efficacy and safety in ...The primary outcomes assessed were the proportion of patients achieving the Cutaneous Lupus Erythematosus Disease Area and Severity Index-50 ( ...
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