New pill aims to calm painful skin flares
NCT ID NCT07828860
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing an experimental oral drug called soquelitinib in adults with moderate-to-severe hidradenitis suppurativa, a chronic skin condition that causes painful lumps and tunnels. The trial aims to see if the drug is safe and can reduce the number of inflammatory lesions. About 25 adults will take soquelitinib tablets, and researchers will track side effects and changes in skin symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental oral drug called soquelitinib
- What this could lead to
- If it works, this could offer a new oral treatment option for people with hidradenitis suppurativa, a painful skin condition with few effective therapies.
- What could go wrong
- This is a small, early-stage trial with 25 participants, so it may not show a clear benefit or may reveal side effects that stop further testing. Results in this small group may not apply to everyone with the condition.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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.
Key Inclusion Criteria: * Adult male or female, ≥18 years of age at the time of signing the informed consent form (ICF) * A diagnosis of moderate-to-severe HS for at least 1 year prior to the Screening visit from review of medical history and/or participant interview. * A total AN count of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) including at least 2 palpable inflammatory nodules at both the Screening and Baseline (Day 1) visits. * Draining tunnel count of ≤20 at the Screening or Baseline (Day 1) visit. * HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline (Day 1) visits. * History of inadequate response, intolerance, or contraindication to a course of systemic antibiotics for treatment of HS or exhibited recurrence after discontinuation of antibiotics through study participant interview and/or review of medical history. * Willing and able to undergo the required skin biopsies. Key Exclusion Criteria: * Currently experiencing, or previous history of, other concomitant skin conditions (eg, psoriasis, cutaneous lupus, previous burns, or extensive tattoos) that would interfere with evaluations of the effect of study intervention on HS. * Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit (Day 1) or that could interfere with the appropriate assessment of HS lesions. * Known immunodeficiency syndrome, history of an invasive infection (eg, sepsis, severe pneumonia, osteomyelitis), or active non-skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline (Day 1). * History of immunosuppression not related to medication (such as common variable hypogammaglobulinemia), history of clinically significant medical conditions (such as anemia, neutropenia, thrombocytopenia, abnormal renal function, or abnormal liver function), planned surgical procedures, or any other reason which in the opinion of the investigator or sponsor would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study intervention, or would put the participant at risk by participating in the study; or permanently wheelchair-bound or bedridden or very poor functional status which prevents the ability to perform self-care. * Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular (eg, unstable angina, unstable arterial hypertension, moderate to severe heart failure \[New York Heart Association Class III/IV\]), respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant safety within the study or confound efficacy and safety assessments.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinical Site 1
Bowling Green, Kentucky, 42104, United States
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Clinical Site 10
Mayfield Heights, Ohio, 44124, United States
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Clinical Site 11
Fargo, North Dakota, 58103, United States
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Clinical Site 2
Owensboro, Kentucky, 42303, United States
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Clinical Site 3
Boston, Massachusetts, 02215, United States
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Clinical Site 4
The Bronx, New York, 10455, United States
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Clinical Site 5
New York, New York, 10023, United States
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Clinical Site 6
Camp Hill, Pennsylvania, 17011, United States
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Clinical Site 7
Nashville, Tennessee, 37211, United States
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Clinical Site 8
Philadelphia, Pennsylvania, 19103, United States
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Clinical Site 9
West Lafayette, Indiana, 47906, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can monthly selfies and symptom logs reveal how chronic skin diseases flare and settle?
- Can a Bladder-Derived patch improve wound healing in daily practice?
- Can a daily pill tame the painful lesions of hidradenitis suppurativa?
- Can a new injection quiet the painful lumps of hidradenitis suppurativa?
- Can a new injection tame the painful lumps of hidradenitis suppurativa?
- Can brain scans reveal the hidden toll of hidradenitis suppurativa?