A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR0302 Tablets as Single Therapy or in Combination With SHR0302 Base Gel in the Treatment of Patients With Non-segmental Vitiligo

Overview

The study is being conducted to evaluate the efficacy, and safety of SHR0302 tablets as single therapy or in combination with SHR0302 Base gel for patients with non-segmental vitiligo.

Interventions

• Drug SHR0302 Tablets
  SHR0302 tablets.
• Drug SHR0302 Base Gel
  SHR0302 Base gel.
• Drug SHR0302 Placebo Tablets
  SHR0302 placebo tablets.
• Drug SHR0302 Base Placebo Gel
  SHR0302 Base placebo gel.

Primary outcome measures

• The percentage change in the facial vitiligo area score index (F-VASI) from the baseline. [Time frame: At Week 24.]

Secondary outcome measures (12)

• The percentage change in F-VASI compared to the baseline. [Time frame: Up to 48 weeks.]
• The percentage change in the total body vitiligo area score index (T-VASI) compared to the baseline. [Time frame: Up to 48 weeks.]
• The proportion of subjects who achieved an improvement of at least 50%/75%/90% compared to the baseline on the F-VASI (F-VASI 50/75/90 response). [Time frame: Up to 48 weeks.]
• The proportion of subjects who achieved at least a 50%/75%/90% improvement in T-VASI compared to the baseline (T-VASI 50/75/90 response). [Time frame: Up to 48 weeks.]
• The absolute change in facial vitiligo area (F-BSA) compared to the baseline. [Time frame: Up to 48 weeks.]
• The percentage change in facial vitiligo area (F-BSA) compared to the baseline. [Time frame: Up to 48 weeks.]
• The percentage change the total body vitiligo area (T-BSA) compared to the baseline. [Time frame: Up to 48 weeks.]
• The absolute change the total body vitiligo area (T-BSA) compared to the baseline. [Time frame: Up to 48 weeks.]
• The proportion of subjects who achieved a significant improvement (4) on the Vitiligo Visual Scale (VNS). [Time frame: Up to 48 weeks.]
• The proportion of subjects who achieved a complete improvement (5) on the Vitiligo Visual Scale (VNS). [Time frame: Up to 48 weeks.]
• The absolute values of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline. [Time frame: Up to 48 weeks.]
• The percentages of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline. [Time frame: Up to 48 weeks.]

Eligibility criteria

Inclusion criteria

• Sign the informed consent form before the clinical trial.
• On the day of signing the informed consent form, the age must be between 18 and 75 years old (inclusive), and it can be either male or female.
• The subjects and their partners had no intention of having children during the study period and within one month after the administration of the drug, did not donate sperm or eggs, and voluntarily adopted effective contraceptive measures. The serum pregnancy test results of the female subjects must be negative and they must not be in the lactation period.
• During the screening process, it was clinically diagnosed as non-segmental vitiligo.
• Throughout the entire research process, the participants agreed to stop using all treatments related to vitiligo as well as any cosmetic products with therapeutic effects.

Exclusion criteria

• Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjects previously diagnosed with other skin pigmentation disorders.
• When the facial skin lesions caused by vitiligo cover more than 33% of the area with white hair.
• During the screening period or at the baseline, there were other active skin lesions or skin infections that might interfere with the use of the study drug or the evaluation of the drug's efficacy.
• Subjects with a history of related infections/communicable diseases or infection/contagion history.
• Known or suspected history of immunosuppression.
• Tuberculosis (TB) or latent tuberculosis infection.
• Positive for human immunodeficiency virus antibody HIV-Ab, positive for syphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, or hepatitis B virus (HBV) infection.
• Subjects who have malignant tumors or have a history of malignant tumors.
• Abnormal thyroid function, with a history of thrombotic diseases within the previous 12 months, and having experienced a cardiovascular or cerebrovascular event that required hospitalization within the previous 12 months.
• There are serious abnormalities in the cardiovascular, mental, renal, liver, immune, gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrine or hematological systems.
• Pregnant women, lactating women, or female participants who plan to become pregnant during the study period.
• Those who are known to be allergic to the test drug or any component of the test drug.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Dermatology Hospital affiliated to Shandong First Medical University — Jinan

Identifiers

NCT: NCT07251595 · SHR0302-202

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗