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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LT-002-158 Tablets | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LT-002-158 Tablets | Drug | The subjects will orally administered LT-002-158 tablets once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Xu | Contact | 021-50561622 | jxu@leadingtac.com |
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| Time to maximum observed plasma concentration (Tmax) |
| up to 42 days |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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