Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
This is a phase2, randomized, double-blind, multi-center, multi-dose and placebo parallel controlled design. The subjects in the study group were given double-blind drugs, and they were taken (orally) after dinner every day according to the requirements of clinical trial scheme.

Official Title
-----------------
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Multi-dose Study to Evaluate Safety and Efficacy of ASC40 Tablets in Subjects With Moderate to Severe Acne Vulgaris.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: ASC40 25mg
* Drug: ASC40 50mg
* Drug: ASC40 75mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: 18-40 years old (including 18 and 40 years old); Investigator's Global Assessment of subject at baseline period was at 3-4. Facial skin lesions of subject need counting as follows: 30   75 inflammatory lesions (the total number of papules, pustules and nodules is 30   75, including no more than 2 nodules), 30   100 non-inflammatory lesions (the total number of open and closed comedones is 30   100); Key Exclusion Criteria: Known to be allergic or hypersensitive to ASC40 tablets; Facial nodules of subject is more than 2 facial nodules The subject with cystic acne Subject with secondary acne such as occupational acne (e.g., chloroacne) and acne caused by corticosteroids (e.g., chloroacne or acne caused by drugs); Serum AST, ALT≥3ULN and Cr exceeded the upper limit of normal range

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group 1<br>ASC40 25mg for 12 weeks | Drug: ASC40 25mg<br>* 25mg of ASC40 orally once daily for 12 weeks.<br>|
| Experimental: Experimental group 2<br>ASC40 50mg for 12 weeks | Drug: ASC40 50mg<br>* 50mg of ASC40 orally once daily for 12 weeks.<br>|
| Experimental: Experimental group 3<br>ASC40 75mg for 12 weeks | Drug: ASC40 75mg<br>* 75mg of ASC40 orally once daily for 12 weeks.<br>|
| Placebo Comparator: Placebo group<br>Placebo for 12 weeks | Drug: Placebo<br>* Placebo orally once daily for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of total lesion count compared with baseline and week 12. |  | Baseline to week 12 | 
| Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12. |  | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes status and changes of average percentage of inflammatory skin lesions count, non-inflammatory skin lesions count and total skin lesions count compared with baseline. |  | Baseline to week 2, 4, 8 and 12 | 
| Ratio of subjects, whose GA grades was 1 or 0, or GA grades was decreased y ≥2 grades compared with baseline and Improvements in classification |  | Baseline to week 2, 4, 8 and 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne vulgaris, ASC40