Hidradenitis Suppurativa (HS)Phase 1/2NCT06932003
A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa
A Phase 1/2 study testing LT-002-158 Tablets in people with Hidradenitis Suppurativa (HS), run by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- LT-002-158 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2025to 30 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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 subjects 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Hang Li, 010-83572350, drlihang@126.com
About this study
Official title: A Phase Ic/II Clinical Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of Multiple Oral Doses of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa
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)
- Being tested
- LT-002-158 Tablets
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-002-158 TabletsDrug
The subjects will orally administered LT-002-158 tablets once a day.
| Study group | Role | What they receive |
|---|---|---|
| LT-002-158 Tablets | Experimental | Not described Receives: Drug: LT-002-158 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1-Day 42
Secondary outcomes (3)
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Measured: Day 1-Day 42
Maximum observed plasma concentration (Cmax)
Measured: up to 42 days
Time to maximum observed plasma concentration (Tmax)
Measured: up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start8 Jul 2025
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932003
- Sponsor's protocol ID
- LT2158CHN005
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ic/II Clinical Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of Multiple Oral Doses of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT06932003
- Acronym / sponsor ID
- LT2158CHN005
- Conditions
- Hidradenitis Suppurativa (HS)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LT-002-158 Tablets | Experimental | Drug: LT-002-158 Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (20 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LT-002-158 TabletsThe subjects will orally administered LT-002-158 tablets once a day. | Drug | LT-002-158 Tablets |
Primary outcome
Incidence and severity of treatment emergent Adverse Events
Time frame: Day 1-Day 42
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.
3 secondary outcomes
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Time frame: Day 1-Day 42
Maximum observed plasma concentration (Cmax)
Time frame: up to 42 days
Time to maximum observed plasma concentration (Tmax)
Time frame: up to 42 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LT-002-158 Tablets in people with Hidradenitis Suppurativa (HS), run by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Xu (021-50561622, jxu@leadingtac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent Adverse Events (time frame: Day 1-Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.