NCT05326672

Phase III Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks.

Detailed description

This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks. Participants who had completed the 8-week clinical trial and were well tolerant to the drug were followed up in one-arm, long-term intermittent administration (up to 52 weeks period). In the long-term medication phase, at each visit point: ① When IGA ≥ 2, Benvitimod cream was continued to be used, twice daily. ② When IGA \< 2, the drug was stopped. In the long-term follow-up, the interval of visits was 4 weeks during the medication phase and 8 weeks during the discontinuation phase. The primary objective is to evaluate the efficacy and safety of Benvitimod cream in the treatment of mild to moderate atopic dermatitis. The primary endpoint is the proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from baseline to week 8. The study is anticipated to last from April 2022 to August 2023 with 240 participants recruited form about 20 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. The study has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Peking University People's Hospital.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Benvitimod Cream	Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.
DRUG	Placebo	Placebo, applied twice daily for 8 weeks after enrolment.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2022-04-13
• Last updated: 2022-05-02

Locations

1 site across 1 country: China