A Trial of SHR0302Base in Patients With Vitiligo

NCT06790862 | Active Not Recruiting Phase 2

• 1 other identifier: SHR0302Base-201
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SHR0302Base in participants with nonsegmental vitiligo.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects who achieved at least a 50% improvement from baseline in the facial-neck vitiligo area score (F-VASI 50 response).

  At week 24.

Secondary Outcomes (5)

• The proportion of subjects who achieved at least a 75% improvement from baseline in the facial-neck vitiligo area score (F-VASI 75 response).

  At week 24.

• The proportion of subjects who achieved at least a 90% improvement from baseline in the facial-neck vitiligo area score (F-VASI 90 response).

  At week 24.

• The proportion of subjects who achieved at least a 50% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 50 response).

  At week 24.

• The proportion of subjects who achieved at least a 75% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 75 response).

  At week 24.

• The proportion of subjects who achieved at least a 90% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 90 response).

  At week 24.

Study Arms (4)

Treatment group 1

EXPERIMENTAL

Drug: SHR0302Base gel

Treatment group 2

EXPERIMENTAL

Drug: SHR0302Base gel

Treatment group 3

EXPERIMENTAL

Drug: SHR0302Base gel

Treatment group 4

PLACEBO COMPARATOR

Drug: SHR0302Base gel placebo

Interventions

SHR0302Base gel DRUG

SHR0302Base gel.

Treatment group 1; Treatment group 2; Treatment group 3

SHR0302Base gel placebo DRUG

SHR0302Base gel placebo.

Treatment group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosis of non-segmental vitiligo.
• The disease has been stable for more than 3 months (90 days) (stable disease is defined as no expansion of the original lesion and no new lesions).
• Subjects and their partners do not plan to have children, do not donate sperm/eggs, and voluntarily use highly effective contraception during the study period until 6 months (female subjects) or 3 months (male subjects) after dosing. Female subjects must have a negative serum pregnancy test and be non-lactating.

You may not qualify if:

• Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; Or previously diagnosed with other skin pigmentation disorders (except nevus halos).
• Conditions at baseline that would interfere with evaluation of vitiligo.
• Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
• Use of protocol-defined treatments within the indicated washout period before baseline.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, 250022, China

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue 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

Model Details: SHR0302Base compared with placebo.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 24, 2025
• Study Start: February 13, 2025
• Primary Completion: March 3, 2026
• Study Completion: April 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)