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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GR2301 injection dose1/Placebo | Experimental |
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| GR2301 injection dose2/Placebo | Experimental |
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| GR2301 injection dose3/Placebo | Experimental |
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| GR2301 injection dose4 | Experimental |
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| GR2301 injection dose5 | Experimental |
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| GR2301 injection dose6 | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR2301 injection | Biological | IL15 monoclonal antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs)( Phase Ib) | Incidence of adverse events | up to 52weeks |
| Proportion of subjects achieving F-VASI 75(Phase II) | 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline and percent change from baseline in F-VASI/T-VASI | 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. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liaison officer | Contact | 021-50805988-8039 | shuxueye@genrixbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong Cui, Ph.D | China-Japan Friendship Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Biological | Placebo |
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| Week 24、36、48、52 |
| Proportion of subjects achieving F/T-VASI 35, 50, and 75 | 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. | Week 24、36、48、52 |
| 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) | 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). | Week 24、36、48、52 |
| Proportion of subjects achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS) | 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. | Week 24、36、48、52 |
| 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) | 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. | Week 24、36、48、52 |
| Incidence of Anti-Drug Antibodys (ADAs) | up to 52weeks |
| drug concentration | up to 52 weeks |