Deucravacitinib for Hidradenitis Suppurativa

Overseen By Prerna Salian, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: TNF agents, Biologics, Opioids, others

Disqualifiers: Active skin disease, Malignancy, Infectious disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called deucravacitinib for hidradenitis suppurativa (HS), a skin condition that causes painful lumps and abscesses. Researchers aim to determine if this medication effectively reduces HS symptoms over 16 weeks. Participants will receive either the actual medication or a placebo (a pill with no active ingredient) to compare results. This trial may suit someone who has experienced at least five painful lumps or abscesses and HS lesions in two different body areas. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before starting, such as non-biologic treatments for HS, TNF agents, new hormonal therapy, oral antibiotics, intralesional kenalog injections, and topical steroids or antibiotics. However, you may continue stable doses of some antibiotics and non-opioid pain relievers. The protocol does not specify all medications, so check with the trial team for your specific situation.

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

Research has shown that deucravacitinib is generally safe for people. Long-term studies on moderate-to-severe plaque psoriasis found no new safety concerns even after five years of use. These studies demonstrated that the treatment remained consistently safe and well-tolerated over time. For hidradenitis suppurativa (HS), a skin condition, early studies are promising and suggest that JAK inhibitors like deucravacitinib can be effective and safe. However, since the current trial for HS is still in an early stage, some unknowns remain about its complete safety for this specific condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for hidradenitis suppurativa, like antibiotics, corticosteroids, or biologics such as adalimumab, focus on reducing inflammation or suppressing the immune system. Deucravacitinib is unique because it acts differently, targeting the TYK2 enzyme, which plays a specific role in the signaling pathways involved in the inflammatory processes of the skin. This targeted mechanism could potentially offer more precise control over the disease with fewer side effects. Researchers are excited about deucravacitinib because it represents a new class of treatment that might provide relief for patients who do not respond well to existing therapies.

What evidence suggests that deucravacitinib might be an effective treatment for hidradenitis suppurativa?

In this trial, participants will receive either deucravacitinib or a placebo. Research has shown that deucravacitinib might help treat hidradenitis suppurativa (HS) by calming the immune system, reducing inflammation and painful lumps. Studies on similar treatments, known as JAK inhibitors, have shown promising results and good safety for people with HS. Deucravacitinib targets specific parts of the immune system involved in HS. While more research is needed, early findings suggest it might effectively reduce symptoms in people with this condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Alexandra Kimball, MD, MPH

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

Adults aged 18-70 with Hidradenitis Suppurativa (HS), having at least 5 abscesses or nodules and lesions in two areas. Women must test negative for pregnancy and use birth control; men cannot be trying to conceive. Excludes those with uncontrolled conditions, recent certain treatments, allergies to tetracycline antibiotics, active skin diseases that could affect HS assessment, current malignancy or history of one within the past five years (except specific treated cancers), chronic infections including HIV/Hepatitis B/C, and those on opioid analgesics.

Inclusion Criteria

I have HS lesions in two different body areas.

Women of Childbearing potential must have a negative serum urine pregnancy test at screening and a negative urine pregnancy test at baseline prior to administration of the first dose of study medication

Able to provide informed consent

Exclusion Criteria

You have a medical condition that weakens your immune system and makes it risky for you to receive immunotherapy.

I haven't taken TNF inhibitors or other biologic drugs in the last 6 weeks.

I have not taken any oral antibiotics in the last 3 weeks, or I have been on a stable dose for 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive either Deucravacitinib or placebo for 16 weeks with assessments at Baseline and weeks 4, 8, 12, and 16

16 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with a follow-up phone call 4 weeks after the last study drug dose

4 weeks

1 visit (phone call)

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The trial is testing Deucravacitinib's safety and effectiveness against a placebo in treating HS. Participants will randomly receive either Deucravacitinib (6 mg twice daily) or a placebo for 16 weeks. The study includes a screening period before treatment starts and follows up four weeks after the last dose via phone call.

How Is the Trial Designed?

Group I: Deucravacitinib - Study Drug Experimental Treatment 1 Intervention

Deucravacitinib group: 6 mg po bid x 16 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo group: 1 tablet po bid x 16 weeks

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

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Bristol-Myers Squibb

Industry 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

Sorafenib, a multi-kinase inhibitor used for treating renal cell and hepatocellular carcinoma, can cause adverse cutaneous reactions, including hidradenitis suppurativa (HS).

This case report highlights the novel occurrence of HS in the axillary and inguinal areas following sorafenib treatment, which has not been previously documented in medical literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa associated with sorafenib initiation. Morse, DC., Chockalingam, R., Pye, A., et al.[2020]

Deucravacitinib (SOTYKTUTM) is an effective oral treatment for moderate to severe plaque psoriasis, with up to 58.4% of patients showing symptom improvement by week 16 in phase 3 trials involving 840 participants.

The drug has a favorable safety profile, with common side effects like upper respiratory infections and herpes simplex infections occurring at manageable rates, and its selectivity may enhance long-term safety compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. Gupta, AK., Wang, T., Vincent, K., 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]

Deucravacitinib, an oral tyrosine kinase 2 inhibitor, showed significant improvements in psoriasis symptoms and quality of life as early as Week 4 in a 12-week Phase 2 trial involving adults with moderate to severe plaque psoriasis.

Patients experienced better quality of life alongside clinical improvements, indicating that as psoriasis symptoms improved, so did their overall well-being, suggesting that deucravacitinib could be a promising new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Thaçi, D., Strober, B., Gordon, KB., et al.[2022]

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]

In a review of 12 randomized controlled trials involving 2915 patients, adalimumab and bimekizumab were found to be effective treatments for moderate-to-severe hidradenitis suppurativa, showing significant improvement in clinical response compared to placebo at 12-16 weeks.

All evaluated biologics, including adalimumab, bimekizumab, and secukinumab, demonstrated similar safety profiles with no increased risk of adverse effects compared to placebo, making them viable options for patients with refractory hidradenitis suppurativa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. Tsai, YC., Hung, CY., Tsai, TF.[2023]

Fostamatinib, a spleen tyrosine kinase inhibitor, was well tolerated in a study of 20 participants with moderate-to-severe hidradenitis suppurativa (HS), showing no serious adverse events and significant improvements in clinical outcomes by week 12.

85% of participants achieved a clinical response (HiSCR) at both week 4 and week 12, indicating that targeting B cells and plasma cells may be an effective treatment strategy for HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proof-of-concept open-label clinical trial of spleen tyrosine kinase antagonism using fostamatinib in moderate-to-severe hidradenitis suppurativa. Jepsen, R., Edwards, C., Flora, A., et al.[2023]

Adalimumab, a treatment for Crohn's disease, has recently been approved for hidradenitis suppurativa, but in this case, it paradoxically triggered the onset of hidradenitis suppurativa in a 40-year-old woman.

This case highlights the potential for unexpected side effects of medications, even those that are effective for other conditions, emphasizing the need for careful monitoring in patients receiving adalimumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa in Crohn's disease during adalimumab therapy: a paradox? Martina, E., Campanati, A., Giuliodori, K., et al.[2019]

In a pooled analysis of two phase 3 clinical trials involving 629 patients, 39% achieved the Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12, indicating the efficacy of adalimumab in treating this condition.

Patients who achieved HiSCR reported significantly better improvements in quality of life and pain levels compared to those who did not respond, highlighting the clinical relevance of HiSCR as a meaningful treatment goal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving Hidradenitis Suppurativa Response Score is Associated with Significant Improvement in Clinical and Patient-reported Outcomes: Post Hoc Analysis of Pooled Data From PIONEER I and II. Kimball, AB., Tzellos, T., Calimlim, BM., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05997277

Study Details | NCT05997277 | Evaluating the Safety and ... A Pilot Study Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo in the Treatment of Moderate-to-severe Hidradenitis Suppurativa (HS).

2. withpower.com withpower.com/trial/phase-2-hidradenitis-suppurativa-11-2023-4a8b8

Deucravacitinib for Hidradenitis Suppurativa This trial tests if Deucravacitinib can help adults with Hidradenitis Suppurativa by reducing inflammation and painful lumps through calming the immune system.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10146646/

Hidradenitis Suppurativa and JAK Inhibitors: A Review of ... Results to date in the literature show promising levels of efficacy and the safety of JAK inhibitors in HS. Several clinical trials are underway.

4. alicantobidmc.org alicantobidmc.org/resources/evaluating-safety-and-efficacy-deucravacitinib-compared-placebo-hidradenitis-suppurativa

Evaluating the Safety and Efficacy of Deucravacitinib ... The objective of this study is to investigate the efficacy of Deucravacitinib (BMS- 986165) in the treatment of Hidradenitis Suppurativa.

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/deucravacitinib-bristol-myers-squibb-hidradenitis-suppurativa-likelihood-of-approval/

Deucravacitinib by Bristol-Myers Squibb for Hidradenitis ... Deucravacitinib is under clinical development by Bristol-Myers Squibb and currently in Phase II for Hidradenitis Suppurativa.

6. investors.bms.com investors.bms.com/iframes/press-releases/press-release-details/2025/New-Five-Year-Sotyktu-deucravacitinib-Data-Show-Consistent-Safety-and-Durable-Response-Rates-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

New Five-Year Sotyktu (deucravacitinib) Data Show ... No new safety signals observed at Year 5 in the POETYK PSO long-term extension trial, consistent with the established Sotyktu safety profile.

7. thedermdigest.com thedermdigest.com/four-year-data-sotyktu-demonstrates-durable-response-rates-consistent-safety-in-moderate-to-severe-plaque-pso/

Four-Year Data: Sotyktu Demonstrates Durable Response ... Deucravacitinib (Sotyktu, Bristol Myers Squibb) showed durable response rates and consistent safety in patients with moderate-to-severe plaque psoriasis ...