Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis

NCT ID: NCT05326659

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-08-31

Brief Summary

This is a retreatment, multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the retreatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 390 participants with mild to moderate stable psoriasis vulgaris 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 psoriasis vulgaris for 12 weeks.

Detailed Description

This is a retreatment, multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the retreatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 390 participants with mild to moderate stable psoriasis vulgaris 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 psoriasis vulgaris for 12 weeks.

The primary objective is to evaluate the efficacy and safety of Benvitimod cream in the long-term (intermittent) treatment of mild to moderate psoriasis vulgaris. The primary endpoint is proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo.

The study is anticipated to last from April 2022 to August 2023 with 390 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

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Benvitimod Cream

Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.

Group Type: EXPERIMENTAL

Benvitimod Cream

Intervention Type: DRUG

Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.

Placebo

Placebo, applied twice daily for 12 weeks after enrolment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, applied twice daily for 12 weeks after enrolment.

Interventions

Benvitimod Cream

Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.

Intervention Type: DRUG

Placebo

Placebo, applied twice daily for 12 weeks after enrolment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18~65 years.
• Patients who were treated with Benvitimod cream and have discontinued medication were again diagnosed as suitable for treatment with Benvitimod cream.
• The participant with diagnosis of mild to moderate stable psoriasis vulgaris:
• BSA < 10%.
• PGA ≥ 2.
• Capable of giving written informed consent.

Exclusion Criteria

• ALT/AST > 3 ULN, BUN/Cr > 1.5 ULN.
• Skin lesions were limited to head，face and skin folds.
• Women who are pregnant, breast-feeding, or planning to become pregnant.
• Known to be allergic to active ingredients or any of the components of the drug.
• Alcoholic, or regular use of Chinese herbs or sedatives, sleeping pills, tranquilizers and other addictive drugs.
• Subjects who have other conditions that may interfere with the evaluation of the efficacy of psoriasis and/or other serious skin diseases other than psoriasis.
• Subjects who have serious diseases of the central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system.
• Subjects who were considered unsuitable to participate in the study by the investigators.
• Received uv phototherapy, photochemotherapy, or systemic therapy (e.g., systemic glucocorticoid, methotrexate, retinoic acid, or cyclosporine) within 4 weeks prior to baseline visit.
• Received topical anti-psoriasis therapy (including topical glucocorticoids, retinoids, vitamin D analogues, or calcineurin inhibitors) within 2 weeks prior to baseline visit, except where the site of administration was not the target lesion after enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhonghao Pharmaceutical

UNKNOWN

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang jianzhong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianzhong Zhang

Role: CONTACT

rmzjz@126.com

010-88325472

Lin Cai

Role: CONTACT

scailin66@hotmail.com

13611236310

Facility Contacts

Lin Cai

Role: primary

scailin66@hotmail.com

13611236310

Other Identifiers

TJ201808BWMD

Identifier Type: -

Identifier Source: org_study_id