Deucravacitinib for Hidradenitis Suppurativa

Overseen By Prerna Salian, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the drug Deucravacitinib for treating Hidradenitis Suppurativa?

Deucravacitinib has shown effectiveness in treating moderate to severe plaque psoriasis, with a significant number of patients experiencing symptom improvement. While this is a different condition, the drug's ability to target similar inflammatory pathways may suggest potential benefits for Hidradenitis Suppurativa. ^{1 2 3 4 5}

How does the drug Deucravacitinib differ from other treatments for hidradenitis suppurativa?

Deucravacitinib is unique because it is a selective tyrosine kinase 2 (TYK2) inhibitor, which works by targeting specific pathways involved in the immune response, unlike other treatments that may target broader immune functions. This specificity could potentially offer a novel approach to managing hidradenitis suppurativa compared to existing treatments like adalimumab, which targets tumor necrosis factor alpha (TNF-alpha). ^{1 6 7 8 9}

Research Team

Alexandra Kimball, MD, MPH

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

I am between 18 and 70 years old.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Deucravacitinib (Janus Kinase (JAK) Inhibitor)

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.

Participant Groups

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 Canada for the following indications:

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

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

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

Hidradenitis suppurativa associated with sorafenib initiation. [2020]

2. 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]

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

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. [2022]

6. Switzerland 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. [2023]

7. Slovenia pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa in Crohn's disease during adalimumab therapy: a paradox? [2019]

8. United States 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. [2023]

9. Sweden 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. [2019]