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

NCT05104125 | Completed Phase 2

• 1 other identifier: ASC40-202
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

Acne vulgaris; ASC40

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (4)

Experimental group 1

EXPERIMENTAL

ASC40 25mg for 12 weeks

Drug: ASC40 25mg

Experimental group 2

EXPERIMENTAL

ASC40 50mg for 12 weeks

Drug: ASC40 50mg

Experimental group 3

EXPERIMENTAL

ASC40 75mg for 12 weeks

Drug: ASC40 75mg

Placebo group

PLACEBO COMPARATOR

Placebo for 12 weeks

Drug: Placebo

Interventions

ASC40 25mg DRUG

25mg of ASC40 orally once daily for 12 weeks.

Experimental group 1

ASC40 50mg DRUG

50mg of ASC40 orally once daily for 12 weeks.

Experimental group 2

ASC40 75mg DRUG

75mg of ASC40 orally once daily for 12 weeks.

Experimental group 3

Placebo DRUG

Placebo orally once daily for 12 weeks.

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• Chen Q, Chen R, Wu L, Xu A, He L, Wang J, Lu Y, Xiao R, Liu L, Feng Y, Zhang C, Dai X, Gao Y, Yan Y, Wu JJ, Xiang L. Denifanstat for moderate-to-severe acne: A Phase 2, randomized, double-blind, placebo-controlled trial. J Eur Acad Dermatol Venereol. 2025 Nov 4. doi: 10.1111/jdv.70119. Online ahead of print.

  PMID: 41186280 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 2, 2021
• Study Start: January 12, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: May 16, 2025

Record last verified: 2023-05

Locations

CN (1)