Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativ… (NCT05997277) | Clinical Trial Compass
TerminatedPhase 2
Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).
Stopped: Funding withdrawn by sponsor due to funding priorities, study cannot continue without funding
United States7 participantsStarted 2023-11-30
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median Change From Baseline in Number of Inflammatory Lesion Counts (Including Combined Counts of Inflammatory Nodules (N) and Abscesses (A)/AN Count) at Week 16.