Clinical trial

Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Name
2021-04-373
Description
Vitiligo is a common acquired depigmentation disorder affecting approximately 2% of the world population. The purpose of this pilot study is to evaluate the effect and the safety of Tildrakizumab in adult participants with vitiligo.
Trial arms
Trial start
2021-09-16
Estimated PCD
2024-04-01
Trial end
2024-04-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Tildrakizumab
2 100mg subcutaneous injections Q4W
Arms:
Vitiligo Patients on Tildrakizumab
Size
12
Primary endpoint
Percentage repigmentation: Vitiligo Area Scoring Index (VASI)
Week 24
Percentage repigmentation: Vitiligo Extent Score (VES)
Week 24
Percentage repigmentation: Photographs
Week 24
Eligibility criteria
Inclusion Criteria: * 18 years of age or older * Diagnosis of vitiligo * Clinically stable vitiligo: defined as no new vitiligo patches and no enlargement of existing patches in previous 3 months. * Able to provide voluntary, written, informed consent Exclusion Criteria: * Clinically active vitiligo: defined as new vitiligo patches or enlargement of existing patches in previous 3 months * Concurrent skin disease in the study area * Immunocompromise * Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2023-10-06

1 organization

1 product

6 indications

Indication
Skin Diseases
Indication
Vitiligo