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A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.
Approximately 64 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FB102 | Active Comparator | Participants in this group will receive FB102. |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB102 | Drug | Route of administration- Intravenous (IV) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAE) following treatment with FB102 | Upto 16 Weeks post first dose administration | |
| Percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI) | The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study | Upto 16 Weeks post first dose administration |
| Number of participants with percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI) | The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study | Upto 16 Weeks post first dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline. | The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study | Upto 16 Weeks post first dose administration |
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Inclusion Criteria:
Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria
Exclusion Criteria:
Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin & Cancer Foundation Australia - The Skin Hospital | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
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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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| Drug |
Route of administration- Intravenous (IV) |
|
| To evaluate the efficacy of FB102 compared to placebo by percent change from Baseline in total-Vitiligo Area Scoring Index (T-VASI) | T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study | Upto 16 Weeks post first dose administration |
| Novatrials | Recruiting | Kotara | New South Wales | 2289 | Australia |
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| Cornerstone Dermatology | Recruiting | Coorparoo | Queensland | 4151 | Australia |
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| Optimal Clinical Trials North | Recruiting | Auckland | Auckland | 0632 | New Zealand |
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| Optimal Clinical Trials Central | Recruiting | Auckland | Auckland | 1010 | New Zealand |
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| Momentum Pukehoke | Recruiting | Auckland | Auckland | 2120 | New Zealand |
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