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This is a Phase II clinical study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of QLS12010 capsules in the treatment of moderate to severe Hidradenitis Suppurativa (HS). The study is comprised of two parts: Part A is a multi-center, open-label, single-dose group proof-of-concept study; Part B is a randomized, double-blind, placebo-controlled dose-ranging study. The overall duration of this study is up to 32 weeks, inclusive of the Screening Period, Treatment Period of up to 24 weeks, and the 4-Week Follow-Up Period for safety assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS12010 Capsule Dose 1 Group | Experimental |
| |
| QLS12010 Capsule Dose 2 Group | Experimental |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS12010 | Drug | QLS12010 oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B] | Week 16 | |
| Incidence and severity of treatment emergent Adverse Events [Part A] | up to approximately 24 weeks |
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Inclusion Criteria:
At screening, the diagnosis of Hidradenitis suppurativa (HS), with a duration of HS ≥ 6 months;
Have moderately to severely active HS at Screening and baseline
According to the assessment of the Investigators, one of the following medical histories exists:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hang Li, M.D. | Contact | 86 136 9305 8190 | drlihang@126.com | |
| Panpan Shang, M.D. | Contact | 86 13810529592 | pans_s@163.com |
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| Placebo | Drug | Matching placebo oral capsules |
|