Can a daily pill tame the painful lesions of hidradenitis suppurativa?
NCT ID NCT06932003
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.
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 1/2
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 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: 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hidradenitis suppurativa (HS) are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, 100044, China
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 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?
- Could botox calm the painful skin flares of hidradenitis suppurativa?