Clinical trial NCT05997277: Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).
Official title: A Pilot Study Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo in the Treatment of Moderate-to-severe Hidradenitis Suppurativa (HS).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2023-08-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The objective of this study is to investigate the efficacy of Deucravacitinib (BMS- 986165) in the treatment of Hidradenitis Suppurativa.

Subjects will be randomly assigned to receive either Deucravacitinib (6 mg twice daily) or placebo for 16 weeks. Assessments will be performed at Baseline and weeks 4, 8, 12, and 16 by a blinded investigator. During this visits, subjects will also be asked to complete a quality of life questionnaire (DLQI) and Visual Analog Scale (VAS) for pain.

A total enrollment of 30 subjects (20 study drug, 10 placebo) is anticipated in this single- center, randomized, double-blind, parallel-group study. This study powered to show a significant difference in efficacy of treatment using the following assumptions based on other clinical trials: baseline average inflammatory lesion count of 12, improvement of 7 in the treatment group and 3 in the placebo group, with a power of 0.87, SD of 3.25 and alpha level of 0.05. The HiSCR will be a secondary endpoint (reduction of inflammatory lesions by 50% with no increase in fistulas or abscesses).

Eligibility criteria: Inclusion Criteria:

* • 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

Exclusion Criteria:

* • 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
  * Are currently pregnant, breastfeeding, or planning to get pregnant during the study

    o male participants who are actively trying to conceive with their partner are also excluded.
  * Previous hypersensitivity reaction to deucravacitinib or to any of the components
  * Known allergy to tetracycline antibiotics
  * Known infection with HIV, hepatitis B or hepatitis C at screening or randomization. Patients who are Hepatitis B Core antibody and/or Hep B Surface Antigen positive will be excluded from this study. Patients who are Hepatitis C ab positive will also be excluded from this study.
  * Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy

Primary outcomes:
measure: Change from Baseline in Inflammatory lesion counts (including combined counts of inflammatory nodules (N) and abscesses (A)/AN count) at week 16.
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: 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
timeFrame: Baseline and Week 16
measure: Changes in IHS4 scores at weeks 4, 8, 12, and 16 compared to baseline.
timeFrame: Baseline, weeks 4, 8, 12, and 16
measure: Changes in Hurley Stage scores at weeks 4, 8, 12, and 16 compared to baseline.
timeFrame: Baseline, weeks 4, 8, 12, and 16
measure: Changes in Dermatology Life Quality Index (DLQI) scores at weeks 4, 8, 12, and 16 compared to baseline.
timeFrame: Baseline, weeks 4, 8, 12, and 16
measure: Changes in Visual Analogue Scale (VAS) pain scores at weeks 4, 8, 12, and 16 compared to baseline.
timeFrame: Baseline, weeks 4, 8, 12, and 16
Other outcomes:
measure: Change from baseline in draining fistula counts at week 16.
timeFrame: Baseline and Week 16
measure: Changes in lesion counts (A, N, AN) at weeks 4, 8, and 12 compared to baseline.
timeFrame: Baseline and weeks 4, 8, and 12
measure: Changes in ulceration at weeks 4, 8, 12, and 16 compared to baseline.
timeFrame: Baseline and weeks 4, 8, 12 and 16
measure: Change in clinical phenotype at week 16 compared to baseline.
timeFrame: Baseline and week 16
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Alexandra Kimball, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: