Vitiligo
Conditions
Keywords
IL15
Brief summary
This is a randomized, double-blind, placebo-controlled Phase Ib/II clinical trial of multiple subcutaneous injections of GR2301 in combination with phototherapy to evaluate the tolerability, safety, pharmacokinetics, and preliminary efficacy in trial participants with vitiligo. The trial will be conducted in two stages: a dose-escalation stage (Phase Ib) and an expansion cohort stage (Phase II).
Interventions
BIOLOGICALGR2301 injection
IL15 monoclonal antibody
BIOLOGICALPlacebo
Placebo
Sponsors
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Meet the clinical diagnosis of non-segmental vitiligo at screening visit and baseline visit, and meet the following criteria: clinical diagnosis of non-segmental vitiligo for at least 3 months at screening visit; facial affected BSA ≥0.5% and total body affected BSA ≥3% at screening visit and baseline visit; F-VASI and T-VASI scores meet the criteria at screening visit and baseline visit. 2. Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and provide signed written informed consent by the trial participant or their legally authorized representative. Main
Exclusion criteria
1. Vitiligo-related medical conditions and other dermatologic diseases/conditions. 2. Prior permanent tattooing or grafting within the vitiligo lesions. 3. Have absolute contraindications to phototherapy; or have relative contraindications to phototherapy (as comprehensively judged by the investigator). 4. Are unwilling or unable to comply with the permitted and prohibited concomitant medications/treatment specifications of this trial, and cannot meet the protocol-required washout period for medications/treatments prior to randomization. 5. Have a serious underlying disease that, in the investigator's opinion, may pose a safety risk to the trial participant if enrolled in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs)( Phase Ib） | up to 52weeks | Incidence of adverse events |
| Proportion of subjects achieving F-VASI 75(Phase II) | Week 24 | VASI(vitiligo area scoring index) is a clinician-reported outcome used to assess the affected body surface area and the degree of depigmentation. F-VASI represents the assessment of facial vitiligo lesions. F-VASI75 means percentage of subjects with at least a 75% decrease from baseline in F-VASI. The higher the VASI score, the more severe the skin lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline and percent change from baseline in F-VASI/T-VASI | Week 24、36、48、52 | VASI(vitiligo area scoring index) is a clinician-reported outcome used to assess the affected body surface area and the degree of depigmentation. F-VASI represents the assessment of facial vitiligo lesions, and T-VASI represents the assessment of total body vitiligo lesions. The higher the VASI score, the more severe the skin lesion. |
| Proportion of subjects achieving F/T-VASI 35, 50, and 75 | Week 24、36、48、52 | VASI(vitiligo area scoring index) is a clinician-reported outcome used to assess the affected body surface area and the degree of depigmentation. F-VASI represents the assessment of facial vitiligo lesions, and T-VASI represents the assessment of total body vitiligo lesions. The higher the VASI score, the more severe the skin lesion. F/T-VASI 35, 50, and 75 represent at least a 35%, 50%, or 75% reduction from baseline in either F-VASI or T-VASI. |
| Percent change from baseline in facial body surface area (F-BSA) and total body surface area (T-BSA) affected by vitiligo | Week 24、36、48、52 | — |
| Proportion of subjects achieving a score of 0 or 1 on the Facial Physician's Global Vitiligo Assessment (F-PhGVA) and the Total Physician's Global Vitiligo Assessment (T-PhGVA) | Week 24、36、48、52 | The severity of Facial Physician's Global Vitiligo Assessment (F-PhGVA) and the Total Physician's Global Vitiligo Assessment (T-PhGVA) will be assessed separately by the study physician using the PhGVA, both on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Proportion of subjects achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS) | Week 24、36、48、52 | The Vitiligo Noticeability Scale (VNS) is a patient-reported outcome measure of treatment success for vitiligo, using a 5-point scale, where a score of 4 or 5 can be defined as treatment success. |
| Proportion of subjects achieving a score of 1 or 2 on the Facial Patient Global Impression of Change for Vitiligo (F-PaGIC-V) and the Total Patient Global Impression of Change for Vitiligo (T-PaGIC-V) | Week 24、36、48、52 | The Patient Global Impression of Change-Vitiligo (PaGIC-V) is a self-assessment by trial participants of the improvement in facial vitiligo (F-PaGIC-V) and total body vitiligo (T-PaGIC-V), using a 7-point scale, where a PaGIC-V score of 1 or 2 can be defined as treatment success. |
| Incidence of Anti-Drug Antibodys (ADAs) | up to 52weeks | — |
| drug concentration | up to 52 weeks | — |
Contacts
CONTACTliaison officer
PRINCIPAL_INVESTIGATORYong Cui, Ph.D
China-Japan Friendship Hospital
Outcome results
None listed