Deucravacitinib for Lupus

Recruiting at 2 trial locations

Overseen By First line of the email MUST contain the NCT# and Site#

Age: 18+

Sex: Any

Trial Phase: Phase 4

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

35 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if 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 treating lupus?

Deucravacitinib is being studied for lupus because it is a TYK2 inhibitor, which is a type of drug that can help control the immune system. Similar drugs, like baricitinib, have shown benefits in treating lupus by reducing disease activity, suggesting that Deucravacitinib might also be effective. ^{1 2 3 4 5}

What is known about the safety of deucravacitinib for lupus?

Deucravacitinib has been studied for safety in a clinical trial for lupus, showing it is generally safe for humans, but like any medication, it may have side effects. Always discuss potential risks with your doctor. ^{1 6 7 8 9}

How is the drug deucravacitinib unique for treating lupus?

Deucravacitinib is unique because it is an oral medication that selectively inhibits tyrosine kinase 2 (TYK2), a protein involved in immune system signaling, which helps reduce inflammation in lupus. This mechanism of action is different from other treatments that may target different pathways or require injections. ^{1 3 10 11 12}

What is the purpose of this trial?

The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with Systemic Lupus Erythematosus (SLE) or Discoid/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE), who have already completed study IM011074 or IM011132. Specific eligibility criteria are not provided, but typically include a detailed medical history and current health status.

Inclusion Criteria

Participants must have completed Study IM011074 or Study IM011132 through the protocol-required treatment period

Participants must have received IP within 60 days of enrollment. Exceptions may be granted based upon consultation with BMS.

My doctor thinks deucravacitinib will likely help me.

Exclusion Criteria

Participants must not have any disease or medical condition that, in the opinion of the physician, would make the subject unsuitable for this protocol, would interfere with the interpretation of subject safety or considered unsuitable by the physician for any other reason

Other protocol-defined Inclusion/Exclusion criteria apply.

I do not have active Tuberculosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Continuation Treatment

Continued administration of Deucravacitinib for participants who have completed previous studies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Deucravacitinib

Trial Overview The trial is testing the continued use of Deucravacitinib, a medication potentially beneficial for lupus patients. It's designed for those who've previously been part of related studies and aims to assess long-term effects.

Participant Groups

Group I: Administration of BMS-986165 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]

The approval of belimumab by the US FDA marks a significant advancement in the treatment options for systemic lupus erythematosus (SLE), highlighting the potential for biologic therapies in managing this autoimmune disease.

Recent clinical trials for SLE have successfully utilized well-defined outcome measures and evidence-based strategies, which have contributed to their success and may lead to improved trial designs and therapeutic options in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring outcomes in systemic lupus erythematosus clinical trials. Strand, V., Chu, AD.[2022]

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]

Most randomized clinical trials for biological therapies in systemic lupus erythematosus (SLE) have not met their primary efficacy endpoints, often due to a lack of focus on patient-reported outcomes (PROs) that reflect symptoms important to patients, like fatigue.

The review highlights the importance of incorporating PROs and health-related quality of life (HRQoL) measures in evaluating the effectiveness of biological therapies, suggesting that a combination of generic and disease-specific measures is necessary to fully capture the patient perspective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do biological agents improve health-related quality of life in patients with systemic lupus erythematosus? Results from a systematic search of the literature. Gomez, A., Parodis, I.[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 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 study of 49 patients with active systemic lupus erythematosus (SLE), sirolimus treatment significantly reduced disease activity (SLEDAI-2K score decreased from 6.2 to 4.0) and allowed for a successful tapering of prednisone dosage.

Sirolimus showed promising efficacy in improving serological markers and achieving remission in various SLE manifestations, with 100% remission in arthritis and 88.8% in skin rash, although further research is needed to clarify its role in lupus nephritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis. Peng, L., Wu, C., Hong, R., et al.[2022]

In a study involving 364 patients with systemic lupus erythematosus (SLE), long-term treatment with belimumab combined with standard therapy demonstrated a stable or declining incidence of adverse events over 4 years, indicating a favorable safety profile.

The most common side effects were mild, such as arthralgia and upper respiratory infections, and serious infusion reactions were rare, suggesting that belimumab can be safely administered for extended periods in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Merrill, JT., Ginzler, EM., Wallace, DJ., et al.[2013]

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, a selective tyrosine kinase 2 inhibitor, was found to be safe and well tolerated in a study involving 40 healthy Chinese subjects, with no serious adverse events reported.

The drug showed rapid absorption and a dose-dependent increase in systemic exposure, indicating that it effectively reaches the bloodstream and maintains consistent pharmacokinetics across different doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Jing, S., Lin, Y., Dockens, R., et al.[2023]

In a phase 3 trial involving 66 Japanese patients with moderate to severe plaque psoriasis, deucravacitinib showed significantly higher efficacy compared to placebo and apremilast, with 78.1% of patients achieving a ≥75% reduction in PASI score at Week 16.

The safety profile of deucravacitinib was comparable to that of placebo and apremilast, with similar incidence rates of adverse events, and the most common side effect being nasopharyngitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial. Imafuku, S., Tada, Y., Hippeli, L., 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

Measuring outcomes in systemic lupus erythematosus clinical trials. [2022]

3. 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]

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

Do biological agents improve health-related quality of life in patients with systemic lupus erythematosus? Results from a systematic search of the literature. [2022]

5. 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]

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

Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis. [2022]

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

Tofacitinib Ameliorates Murine Lupus and Its Associated Vascular Dysfunction. [2022]

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

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. [2013]

10. 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]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial. [2023]