A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa

NCT06932003 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: LT2158CHN005
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a Phase Ic/II clinical trial conducted in Chinese patients with moderate-to-severe hidradenitis suppurativa (HS), aiming to evaluate the safety and efficacy of LT-002-158 tablets in the treatment of moderate-to-severe HS. The study consists of two parts. The Phase Ic portion employs an open-label, single-arm design to primarily investigate the safety and tolerability of LT-002-158 tablets in patients with moderate-to-severe HS. The Phase II study adopts a randomized, double-blind, placebo-controlled, parallel-group design, with an open-label, single-arm extension phase, to primarily assess the therapeutic efficacy of LT-002-158 tablets in patients with moderate-to-severe HS.

Conditions

Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment emergent Adverse Events

  Including adverse events (TEAEs) and serious adverse events that occurred during the study period; Clinically significant changes observed in laboratory tests, 12 lead electrocardiograms, vital signs, and physical examinations during the study period.

  Day 1-Day 42

Secondary Outcomes (3)

• Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]

  Day 1-Day 42

• Maximum observed plasma concentration (Cmax)

  up to 42 days

• Time to maximum observed plasma concentration (Tmax)

  up to 42 days

Study Arms (1)

LT-002-158 Tablets

EXPERIMENTAL

Drug: LT-002-158 Tablets

Interventions

LT-002-158 Tablets DRUG

The subjects will orally administered LT-002-158 tablets once a day.

LT-002-158 Tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Diagnosis of hidradenitis suppurativa (HS) with disease duration of at least 6 months prior to enrollment;
• Have inadequate response or intolerance to prior HS treatments and are suitable candidates for this study on investigator's judgment;
• Total count of abscesses and inflammatory nodules ≥4 at baseline;
• No pregnancy plans during the study and for 6 months after the last dose, with agreement to use effective contraception methods;
• Understand and voluntarily sign the informed consent form; Willing and able to to complete patient diary entries as required by the protocol;
• The subject is willing and able to comply with all protocol requirements by investigator's judgment.

You may not qualify if:

• Presence of \>20 fistulas or deeply extensive coalescing lesions;
• 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);
• Any of the following comorbidities:
• Active tuberculosis;
• Active hepatitis B/C, syphilis, or human immunodeficiency virus (HIV) infection;
• 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;
• 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.);
• 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);
• Gastrointestinal disorders or surgeries (gastrectomy, gastric bypass, etc.) that may affect oral drug absorption;
• Family history of sudden death or long QT syndrome, or personal history of congenital/medication-induced long QT syndrome;
• Any of the following laboratory abnormalities:
• Estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) \<60 mL/min/1.73m²;
• Total bilirubin ≥1.5×upper limit of normal (ULN);
• ALT ≥1.5×ULN or AST ≥1.5×ULN;
• Hemoglobin \<9.0 g/dL, WBC \<3.0×10⁹/L, neutrophils \<1.5×10⁹/L, lymphocytes \<0.75×10⁹/L, platelets \<100×10⁹/L;

Sponsors & Collaborators

• Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Juan Xu

CONTACT

021-50561622; jxu@leadingtac.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 17, 2025
• Study Start: April 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04