Trial studying safety and effects for Hidradenitis Suppurativa (HS)
Official title A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT06932003
What this study is testing
What is LT-002-158 Tablets?
LT-002-158 Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hidradenitis suppurativa (hs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join if
- Presence of \>20 fistulas or deeply extensive coalescing lesions;
- Other significant dermatological conditions that may interfere with how well it works evaluation or require concomitant treatment (e.g., seborrheic...
- 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...
See the full eligibility criteria
- 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.
- Presence of \>20 fistulas or deeply extensive coalescing lesions;
- Other significant dermatological conditions that may interfere with how well it works evaluation or require concomitant treatment (e.g., seborrheic dermatitis), or any skin conditions deemed by investigators as...
- 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...
- Immunodeficiency or immune-related disorders (organ/bone marrow transplantation, splenectomy, IgG4-related disease, vasculitis, etc.) or active autoimmune diseases requiring treatment (psoriasis, atopic dermatitis...
- 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...
- 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;
- Serum potassium, magnesium, or calcium below lower limit of normal;
- QTcF \>450 ms or QRS \>110 ms on screening ECG;
- Blood pressure ≥150/90 mmHg despite antihypertensive treatment;
- Use of adalimumab or other biologics within 8 weeks or 5 half-lives prior to first dose (whichever longer) (≤20% of enrolled people may have prior biologic exposure without treatment failure);
- Systemic antibiotic therapy within 2 weeks or systemic retinoid therapy within 4 weeks prior to first dose.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.