Deucravacitinib for Lupus

Recruiting at 194 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

261 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug deucravacitinib for lupus?

Deucravacitinib, a drug that targets specific proteins involved in immune responses, has shown promise in a phase II trial for treating lupus, suggesting it may help manage the disease by reducing its activity. ^{1 2 3 4 5}

What is known about the safety of deucravacitinib for lupus?

Deucravacitinib has been studied for safety in a phase II trial for systemic lupus erythematosus (SLE), which is a type of lupus. This trial was designed to evaluate both how well the drug works and its safety in humans. ^{1 2 5 6 7}

How is the drug deucravacitinib different from other lupus treatments?

Deucravacitinib is unique because it is an oral medication that specifically inhibits TYK2, a protein involved in the immune response, which is different from other lupus treatments like baricitinib that target JAK1 and JAK2 proteins. ^{1 2 5 8 9}

What is the purpose of this trial?

This trial is testing a new medication called BMS-986165 to see if it is safe and can be tolerated by people with Systemic Lupus Erythematosus (SLE).

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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]

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]

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 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]

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 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]

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

Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus. [2022]

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

Real-world efficacy of belimumab in achieving remission or low-disease activity in systemic lupus erythematosus: A retrospective study. [2023]

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

Effect of long-term belimumab treatment on B cells in systemic lupus erythematosus: extension of a phase II, double-blind, placebo-controlled, dose-ranging study. [2022]

5. England 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. [2021]

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

Safety profile of baricitinib in patients with systemic lupus erythematosus: an integrated analysis. [2023]

7. 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]

8. England 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. [2021]