Deucravacitinib for Cutaneous Lupus Erythematosus
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive deucravacitinib or placebo to assess safety, efficacy, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Deucravacitinib
- Placebo
Deucravacitinib is already approved in United States, European Union, Canada for the following indications:
- Moderate to severe plaque psoriasis
- Moderate to severe plaque psoriasis
- Moderate to severe plaque psoriasis
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Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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