Experimental pill shows early promise for painful skin condition
NCT ID NCT05997277
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This pilot study tested the drug deucravacitinib against a placebo in people with moderate-to-severe hidradenitis suppurativa, a chronic skin condition causing painful lumps. Only 7 people enrolled before the study was stopped early. The goal was to see if the drug could reduce inflammatory lesions over 16 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Deucravacitinib (a targeted oral medication that blocks a specific immune pathway)
- What this could lead to
- If it works, this could point toward a new oral treatment option for hidradenitis suppurativa, a painful skin condition.
- What could go wrong
- This is a very small, early pilot study that was terminated early with only 7 participants, so results are limited and may not be reliable. The drug may not prove effective or safe in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
7 people
The number who actually took part.
- Started
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Nov 2023
- Finished
-
Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a mediterranean diet tame hidradenitis suppurativa?
- Can we predict the path of chronic skin disease?
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- Could childhood trauma fuel skin inflammation?