LT-002-158 tablets for hidradenitis suppurativa in Chinese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This two-part study in Chinese adults with moderate-to-severe hidradenitis suppurativa starts with an open-label, single-arm Phase Ic to assess safety and tolerability of LT-002-158 tablets. It continues with a Phase II portion that uses a randomized, double-blind, placebo-controlled design (with an open-label extension) to evaluate efficacy, followed by safety data collection. Eligible participants have HS for at least six months, a baseline abscess and inflammatory nodule count of four or more, and prior inadequate response to HS therapies. The trial excludes individuals with extensive fistulas or other significant skin conditions. The lead sponsor is Leadingtac Pharmaceutical (Shaoxing) Co., Ltd., with the study conducted at Peking University People’s Hospital in Beijing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Juan Xu
• Email: jxu@leadingtac.com
• Phone: 021-50561622

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Soquelitinib in adults with hidradenitis suppurativa

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• ORKA-002 versus placebo for moderate-to-severe hidradenitis suppurativa

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  Recruiting at 25 sites Phase 2 Oruka Therapeutics, Inc. · Birmingham, Alabama and 24 other locations · NCT07783542

• SPY072 in adults with moderate to severe hidradenitis suppurativa

  This study tests whether SPY072 can help adults with moderate to severe hidradenitis suppurativa when added to their current care, compared with a placebo over 16 weeks.

  Recruiting at 7 sites Phase 2 Spyre Therapeutics, Inc. · Birmingham, Alabama and 33 other locations · NCT07766005

• Brain activity patterns in people with hidradenitis suppurativa and how treatments may relate to changes

  This study tests whether adults with hidradenitis suppurativa show different resting brain activity than healthy people and whether these brain patterns relate to symptoms like pain and mood, and whether they change after 3 months of standard biologic or small-molecule treatment.

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• Roflumilast 0.3% Foam for Hidradenitis Suppurativa in Teens and Adults

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  Recruiting Phase 2 Harrison Dermatology · Missouri City, Texas · NCT07689188

• Global health study on hidradenitis suppurativa

  This study tests how people with hidradenitis suppurativa access care and what treatments they receive across different health systems.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.