Phase IV Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults

NCT05064748 | Unknown Phase 4

• 1 other identifier: TJ202105BWMD
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will use the Benvitimod cream at the skin with psoriasis for 12 weeks.

Conditions

Psoriasis

Keywords

Benvitimod Cream; Psoriasis; Topical Treatment

Outcome Measures

Primary Outcomes (2)

• Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12

  The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.

  Week 12

• Percentage decline in Physician Global Assessment (PGA) score at Week 12

  The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.

  Week 12

Secondary Outcomes (12)

• Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 8

  Week 8

• Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8

  Week 8

• Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8

  Week 8

• Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8

  Week 8

• Change in percent of total body surface area (%BSA) affected from Baseline to Week 8

  Week 8

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

Drug: Benvitimod

Interventions

Benvitimod DRUG

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

Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants ages at least 18 years.
• The participant with diagnosis of mild to moderate stable psoriasis vulgaris.
• BSA involvement \<10%.
• Capable of giving written informed consent.

You may not qualify if:

• Planned Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation during the study period.
• Known allergies to the active ingredient or excipients of the drug.
• Pregnant females, lactating females.
• The patients who were considered unsuitable to participate in the study by the investigators.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Zhonghao Pharmaceutical: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: June 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: September 30, 2024
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

CN (1)