Status:
TERMINATED
Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 deucravacitini...
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 Deucrava...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05997277
Start Date
November 30 2023
End Date
April 10 2025
Last Update
May 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215