Deucravacitinib for Lupus

No longer recruiting at 225 trial locations

Overseen By Norman Gaylis, Site 0115

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Active tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: Long-term

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986165 (also known as Deucravacitinib) for individuals with Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks the body. The main goal is to assess the treatment's safety and tolerability over an extended period. Participants will receive one of three different doses to determine which is most effective. Individuals who have completed a previous SLE study and are already on the study drug might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that deucravacitinib, also known as BMS-986165, demonstrates promising safety results from earlier studies. In trials for conditions such as psoriatic arthritis and systemic lupus erythematosus (SLE), most patients tolerated deucravacitinib well. Reports of side effects were fewer compared to other treatments like anifrolumab and litifilimab, which are used for similar conditions.

While some side effects occurred, they were generally mild and manageable. This suggests that deucravacitinib could be a safe option for people with SLE. However, each person's experience can differ, so discussing any concerns with a healthcare provider is crucial. ^{1 2 3 4 5}

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

Researchers are excited about deucravacitinib for lupus because it works differently from current treatments. While standard lupus therapies often include corticosteroids or immunosuppressants that broadly dampen the immune system, deucravacitinib specifically targets the TYK2 enzyme, which plays a crucial role in the inflammatory pathways involved in lupus. This targeted approach could potentially offer more effective control of symptoms with fewer side effects. Additionally, the precision of deucravacitinib's mechanism may lead to improved outcomes for patients who do not respond well to existing treatments.

What evidence suggests that BMS-986165 might be an effective treatment for lupus?

Research has shown that deucravacitinib, also known as BMS-986165, may help treat Systemic Lupus Erythematosus (SLE), a type of lupus. In one study, participants experienced significant symptom improvements by week 32. Another study found that by week 48, patients reported less pain and fatigue, and their overall quality of life improved. Specifically, 64% of patients experienced a major response, meaning their symptoms improved significantly. These findings suggest that deucravacitinib could be an effective treatment option for people with lupus. Participants in this trial will receive one of three different doses of BMS-986165 to evaluate its effectiveness and safety. ^{1 5 6 7 8}

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 people who have completed a previous SLE study (NCT03252587) and are currently on the blinded study drug. Exceptions may be made for those who missed doses due to special circumstances like COVID-19, with approval from the trial physician.

Inclusion Criteria

Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.

Exclusion Criteria

Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason

There are other requirements or restrictions for participating in the study that are defined in the study's protocol.

I have active tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986165 to assess long-term safety and efficacy

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986165

Trial Overview The focus of this study is on BMS-986165's long-term safety and effectiveness in treating Systemic Lupus Erythematosus. Participants will continue using this medication over an extended period to monitor its ongoing impact.

How Is the Trial Designed?

Group I: BMS-986165 Dose 3 Experimental Treatment 1 Intervention

Group II: BMS-986165 Dose 2 Experimental Treatment 1 Intervention

Group III: BMS-986165 Dose 1 Experimental Treatment 1 Intervention

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

Published Research Related to This Trial

In a phase II trial involving 239 adults with systemic lupus erythematosus (SLE), baricitinib at a dose of 4 mg significantly reduced several inflammatory cytokines compared to placebo after 12 weeks, indicating its potential efficacy in managing SLE-related inflammation.

The study suggests that baricitinib may work through a multitargeted mechanism by downregulating key cytokines associated with SLE, which could lead to improved disease activity, although further research is needed to fully understand its clinical relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus. Dörner, T., Tanaka, Y., Dow, ER., et al.[2022]

Baricitinib treatment led to significant reductions in anti-dsDNA antibodies and IgG levels in patients with systemic lupus erythematosus (SLE), indicating its potential efficacy in managing this condition.

The study showed that baricitinib resulted in a rapid decrease in anti-dsDNA levels starting as early as 2 weeks, suggesting it may influence B cell activity, although further research is needed to confirm this mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib decreases anti-dsDNA in patients with systemic lupus erythematosus: results from a phase II double-blind, randomized, placebo-controlled trial. Dörner, T., van Vollenhoven, RF., Doria, A., et al.[2022]

In a 24-week study involving 274 patients with systemic lupus erythematosus (SLE), the JAK1 and JAK2 inhibitor baricitinib significantly reduced the expression of genes associated with the JAK/STAT pathway, which is crucial in SLE pathogenesis.

Baricitinib treatment also led to a significant decrease in serum levels of key cytokines IL-12p40 and IL-6, which are elevated in SLE, indicating its potential efficacy in managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib-associated changes in global gene expression during a 24-week phase II clinical systemic lupus erythematosus trial implicates a mechanism of action through multiple immune-related pathways. Dörner, T., Tanaka, Y., Petri, MA., et al.[2021]

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]

In a safety analysis involving 1655 adult patients with systemic lupus erythematosus (SLE) treated with baricitinib for up to 3.5 years, the incidence of infections was similar across baricitinib (4 mg and 2 mg) and placebo groups, with common infections including urinary tract infections and COVID-19.

The study found no significant increase in serious infections or venous thromboembolic events associated with baricitinib treatment, indicating that its safety profile remains consistent with previous findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of baricitinib in patients with systemic lupus erythematosus: an integrated analysis. Morand, E., Smolen, JS., Petri, M., et al.[2023]

In a 24-week phase 2 study involving 314 patients with systemic lupus erythematosus, the 4 mg dose of baricitinib significantly improved symptoms, with 67% of patients achieving resolution of arthritis or rash compared to placebo.

The safety profile of baricitinib was consistent with previous studies, with serious adverse events occurring in 10% of patients on the 4 mg dose, indicating that while effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Wallace, DJ., Furie, RA., Tanaka, Y., et al.[2021]

Citations

1. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-Two-Late-Breaking-Presentations-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-Psoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/default.aspx

Corporate news details New data showed ACR20 responses (at least a 20 percent improvement in signs and symptoms of disease) achieved at Week 16 (Sotyktu, 54.2%; ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142172/

efficacy on patient-reported outcomes in a phase ... Patients with SLE experienced greater improvements in pain, fatigue and health-related quality-of-life scores at week 48 with deucravacitinib ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03252587

NCT03252587 | An Investigational Study to Evaluate BMS- ... This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

4. news.bms.com news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Encouraging-Data-from-Phase-1-Breakfree-1-Study-of-CD19-NEX-T-CAR-T-Cell-Therapy-in-Three-Chronic-Autoimmune-Diseases-at-ACR-Convergence-2025/default.aspx

Corporate news details Promising initial results showed that of the efficacy-evaluable patients, 64% of patients achieved a major response, and 27% achieved a moderate ...

5. hss.edu hss.edu/research/clinical-trials/lupus-deucravacitinib-sle-systemic-lupus-erythematosus

A Phase 3, Randomized, Double-blind, Placebo-controlled ... In a phase 2 study, deucravacitinib significantly improved SRI-4 at Week 32, as well as SRI-4, BICLA, LLDAS, CLASI-50, and changes in active, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05620407

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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40920289/

Design of Two Randomized, Placebo-Controlled, Phase 3 ... Systemic lupus erythematosus (shortened to SLE) is a long-term autoimmune condition that affects many parts of the body, including the skin, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1568997224002143

Deucravacitinib shows superior efficacy and safety in ... Anifrolumab and litifilimab are effective and safe treatment options in CLE. However, deucravacitinib demonstrated superior efficacy and safety with fewer ...