New pill aims to calm painful skin flares

NCT ID NCT07828860

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

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

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.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Clinical Site 1

    Bowling Green, Kentucky, 42104, United States

  • Clinical Site 10

    Mayfield Heights, Ohio, 44124, United States

  • Clinical Site 11

    Fargo, North Dakota, 58103, United States

  • Clinical Site 2

    Owensboro, Kentucky, 42303, United States

  • Clinical Site 3

    Boston, Massachusetts, 02215, United States

  • Clinical Site 4

    The Bronx, New York, 10455, United States

  • Clinical Site 5

    New York, New York, 10023, United States

  • Clinical Site 6

    Camp Hill, Pennsylvania, 17011, United States

  • Clinical Site 7

    Nashville, Tennessee, 37211, United States

  • Clinical Site 8

    Philadelphia, Pennsylvania, 19103, United States

  • Clinical Site 9

    West Lafayette, Indiana, 47906, United States

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