Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04338581 | Evaluation of AMG 714 for Vitiligo | PHASE2 | COMPLETED | 60 | — | — | Dec 11, 2020 | Apr 2, 2025 | Apr 21, 2026 | 7 | United States |
An F-VASI35 responder is defined as a participant who has at least 35% improvement from Baseline in the facial vitiligo area scoring index (F-VASI). F-VASI assesses the area of the face affected by vitiligo. F-VASI is determined by the product of the percent of vitiligo involvement (percent of body surface area \[BSA\]) and the degree of depigmentation estimated to the nearest of the following percentages: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The percentage of BSA (hand or thumb unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator. F-VASI has a possible range from 0 to 3.5, with higher scores indicating more severe disease. Participants missing the F-VASI assessment at Week 24 are imputed as F-VASI35 non-responders.
| Arm | Type | Description |
|---|---|---|
| AMG 714 | EXPERIMENTAL | Participants will be administered 300 mg AMG 714 beginning at Week 0 and every 2 weeks thereafter through Week 10 (for a total of 6 doses). Each dose will be administered as 2 subcutaneous injections (1.5 mL each). |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered placebo as 2 subcutaneous injections (1.5 mL each) beginning at Week 0 and every 2 weeks thereafter through Week 10 (for a total of 6 doses). |
| Name | Type | Description |
|---|---|---|
| AMG 714 | BIOLOGICAL | anti-IL-15 monoclonal antibody (Anti-IL-15 MAB) |
| Placebo | BIOLOGICAL | Placebo for AMG 714 |
| nbUVB phototherapy | PROCEDURE | Participants will undergo narrow band ultraviolet B (nbUVB) phototherapy if their total body Vitiligo Area Scoring Index (T-VASI) does not improve by ≥ 25% at Week 24 compared to Week 0. Phototherapy will be administered in accordance with the Vitiligo Working Group expert recommendations. |
Individuals must meet all of the following criteria to be eligible for enrollment as study participants: 1. Adults 18-75 years of age. 2. Clinical diagnosis of active or stable vitiligo made by a dermatologist, as defined in Protocol Section 3.4.2. 3. F-VASI ≥ 0.25 (Appendix 2 of Protocol). 4. T-VA...
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