Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

NCT05997277 | Terminated Phase 2 FDA Drug

• 1 other identifier: 2023P000400
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized, proof of concept study. 30 patients aged 18 and over with HS will be included in this single center, randomized, double-blind, parallel-group study. Dosage of deucravacitinib will be given according to the investigational regimen as follows: 6 mg po bid for 16 weeks. The study compromises a 4-week screening period, a 16-week study period, and a 4-week follow-up period. The follow-up period consists of a follow-up phone call 4 weeks after the last study drug dose.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Inflammatory lesion counts (including combined counts of inflammatory nodules (N) and abscesses (A)/AN count) at week 16.

  We will assess the average change in inflammatory lesion count per subject following 16 weeks of treatment as compared to baseline. Inflammatory lesions are defined as inflammatory nodules or abscesses.

  Baseline and Week 16

Secondary Outcomes (5)

• The population treatment effect on proportion of participants with Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16 for the active treatment group relative to placebo without regard to IP compliance

  Baseline and Week 16

• Changes in IHS4 scores at weeks 4, 8, 12, and 16 compared to baseline.

  Baseline, weeks 4, 8, 12, and 16

• Changes in Hurley Stage scores at weeks 4, 8, 12, and 16 compared to baseline.

  Baseline, weeks 4, 8, 12, and 16

• Changes in Dermatology Life Quality Index (DLQI) scores at weeks 4, 8, 12, and 16 compared to baseline.

  Baseline, weeks 4, 8, 12, and 16

• Changes in Visual Analogue Scale (VAS) pain scores at weeks 4, 8, 12, and 16 compared to baseline.

  Baseline, weeks 4, 8, 12, and 16

Other Outcomes (4)

• Change from baseline in draining fistula counts at week 16.

  Baseline and Week 16

• Changes in lesion counts (A, N, AN) at weeks 4, 8, and 12 compared to baseline.

  Baseline and weeks 4, 8, and 12

• Changes in ulceration at weeks 4, 8, 12, and 16 compared to baseline.

  Baseline and weeks 4, 8, 12 and 16

Study Arms (2)

Deucravacitinib - Study Drug

EXPERIMENTAL

Deucravacitinib group: 6 mg po bid x 16 weeks

Drug: Deucravacitinib

Placebo

PLACEBO COMPARATOR

Placebo group: 1 tablet po bid x 16 weeks

Drug: Placebo

Interventions

Deucravacitinib DRUG

Deucravacitinib is a stable deuterium-containing compound (where deuterium is a stable, nonradioactive isotope of hydrogen) and a potent, highly selective small molecule inhibitor of TYK2. Deucravacitinib has a unique mode of binding that provides the high selectivity over the other members of the JAK family of nonreceptor tyrosine kinases. 1 active oral tablet (6mg) in the morning and evening for 16weeks.

Also known as: BMS-986165, SOTYKTU

Deucravacitinib - Study Drug

Placebo DRUG

Placebo will consist of a tablet (0mg) and will be administered orally BID for 16weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female at least 18 -70 years of age
• Able to provide informed consent
• Have at least 5 abscesses and/or inflammatory nodule (AN) count at baseline visits
• Have HS lesions in 2 distinct anatomical 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
• Women of childbearing potential must be willing to continue a highly effective method of birth control throughout the study (oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant).
• Tuberculosis Screening
• Negative IGRA screening for tuberculosis within 3 months prior to screening, OR
• If a positive history of latent tuberculosis:
• Currently receiving treatment for latent TB per standard of care (with at least 4 weeks of treatment prior to baseline visit)
• Have documentation of having completed treatment within 5 years prior to baseline • Agree not to have a live vaccination during the study

You may not qualify if:

• Any other active skin disease that in the opinion of the investigator would interfere with the assessment of HS
• Have greater than 20 draining fistula at baseline
• Receipt of non-biologic treatments for HS within 4 weeks prior to baseline other than antibiotics or hormonal therapy
• Receipt of TNF agents (i.e. Infliximab, adalimumab) or other biologics within 6 weeks prior to baseline
• Receipt of new hormonal therapy for HS within 3 weeks prior to baseline
• Receipt of oral antibiotics within 3 weeks prior to baseline.
• o NOTE: subjects on concomitant antibiotics with a stable dose for 4 weeks prior to baseline visit may be included in the study. Only 25% of total enrollment may be on concomitant antibiotics.
• Receipt of intralesional kenalog injections within 2 weeks prior to baseline
• Receipt of topical steroids or topical antibiotics for HS for 2 weeks prior to baseline
• o NOTE: subjects may continue topical washes (benzoyl peroxide, chlorhexidine, zinc pyrithione, dilute bleach)
• Receipt of opioid analgesics or other concomitant analgesics for HS pain within 72 hours prior to the baseline visit
• o Concomitant use of non-opioid analgesics for treatment of chronic non-HS pain is allowed as long as the dose has been stable for 14 days prior to baseline and expected to remain constant throughout the study
• Any uncontrolled diagnosis or condition that in the opinion of the investigator will interfere with the assessments or the study.
• Currently has a malignancy or a history of a malignancy within 5 years before screen (except successfully treated non-melanoma skin cancer or cervical carcinoma in situ)
• History of an ongoing, chronic or recurrent infectious disease

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Alexandra Kimball, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: November 30, 2023
• Primary Completion: February 25, 2025
• Study Completion: April 10, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)