Can a daily pill tame the painful lesions of hidradenitis suppurativa?

NCT ID NCT06932003

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests an experimental oral drug called LT-002-158 in adults with moderate-to-severe hidradenitis suppurativa, a chronic skin condition causing painful abscesses and nodules. The study first checks the drug's safety and tolerability, then compares its effectiveness against a placebo in a randomized, double-blind design. Participants take the tablet once daily, and researchers monitor side effects, drug levels in the blood, and changes in skin lesions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LT-002-158 tablets, an oral drug taken once daily
What this could lead to
If it works, this could offer a new daily pill to reduce painful flare-ups and lesions in people with hidradenitis suppurativa.
What could go wrong
This is an early-stage trial with only 12 participants, so the drug may not prove effective or safe in larger groups. Possible side effects are still being studied.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

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

Started

Jul 2025

Expected to finish

Dec 2028

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 to 75 years

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.

Inclusion Criteria: 1. Male or female aged 18 to 75 years (inclusive), with body mass index (BMI) between 17.5 and 40.0 kg/m² (inclusive) and body weight ≥45.0 kg; 2. Diagnosis of hidradenitis suppurativa (HS) with disease duration of at least 6 months prior to enrollment; 3. Have inadequate response or intolerance to prior HS treatments and are suitable candidates for this study on investigator's judgment; 4. Total count of abscesses and inflammatory nodules ≥4 at baseline; 5. No pregnancy plans during the study and for 6 months after the last dose, with agreement to use effective contraception methods; 6. Understand and voluntarily sign the informed consent form; Willing and able to to complete patient diary entries as required by the protocol; 7. The subject is willing and able to comply with all protocol requirements by investigator's judgment. Exclusion Criteria: 1. Presence of \>20 fistulas or deeply extensive coalescing lesions; 2. Other significant dermatological conditions that may interfere with efficacy evaluation or require concomitant treatment (e.g., seborrheic dermatitis), or any skin conditions deemed by investigators as potentially affecting study assessments (e.g., tattoos, scars); 3. Any of the following comorbidities: 1. Active tuberculosis; 2. Active hepatitis B/C, syphilis, or human immunodeficiency virus (HIV) infection; 3. Severe cardiovascular diseases including: Congestive heart failure (NYHA class ≥II); Angina pectoris \>grade 1; Known structural heart disease; Major cardiovascular events within screening period (myocardial infarction, unstable angina, acute coronary syndrome, stroke or transient ischemic attack, etc.); Ventricular fibrillation; TDP; atrial fibrillation; Unexplained syncope of non-cardiac origin; 4. Immunodeficiency or immune-related disorders (organ/bone marrow transplantation, splenectomy, IgG4-related disease, vasculitis, etc.) or active autoimmune diseases requiring treatment (psoriasis, atopic dermatitis, rheumatoid arthritis, etc.); 5. History or symptoms of malignancy in any organ system within 5 years prior to screening, regardless of treatment status or evidence of recurrence/metastasis (except appropriately treated non-metastatic cutaneous carcinoma in situ or cervical basal/squamous cell carcinoma in situ); 6. Gastrointestinal disorders or surgeries (gastrectomy, gastric bypass, etc.) that may affect oral drug absorption; 4. Family history of sudden death or long QT syndrome, or personal history of congenital/medication-induced long QT syndrome; 5. Any of the following laboratory abnormalities: 1. Estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) \<60 mL/min/1.73m²; 2. Total bilirubin ≥1.5×upper limit of normal (ULN); 3. ALT ≥1.5×ULN or AST ≥1.5×ULN; 4. Hemoglobin \<9.0 g/dL, WBC \<3.0×10⁹/L, neutrophils \<1.5×10⁹/L, lymphocytes \<0.75×10⁹/L, platelets \<100×10⁹/L; 5. Serum potassium, magnesium, or calcium below lower limit of normal; 6. QTcF \>450 ms or QRS \>110 ms on screening ECG; 7. Blood pressure ≥150/90 mmHg despite antihypertensive treatment; 6. Use of adalimumab or other biologics within 8 weeks or 5 half-lives prior to first dose (whichever longer) (≤20% of enrolled subjects may have prior biologic exposure without treatment failure); 7. Systemic antibiotic therapy within 2 weeks or systemic retinoid therapy within 4 weeks prior to first dose.

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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

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  1. The places running it

    1 site. 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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

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