Trial Outcomes & Findings for Evaluation of AMG 714 for Vitiligo (NCT NCT04338581)

Seven sites in the United States were activated. All seven sites randomized participants. The first site was activated in November 2020 and the last participant was randomized in May 2024.

Evaluation of AMG 714 for Vitiligo

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.

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 any visit are imputed as F-VASI35 non-responders for that visit.

An F-VASI25 responder is defined as a participant who has at least 25% 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 any visit are imputed as F-VASI25 non-responders for that visit.

An F-VASI50 responder is defined as a participant who has at least 50% 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 any visit are imputed as F-VASI50 non-responders for that visit.

An F-VASI75 responder is defined as a participant who has at least 75% 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 any visit are imputed as F-VASI75 non-responders for that visit.

An F-VASI90 responder is defined as a participant who has at least 90% 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 any visit are imputed as F-VASI90 non-responders for that visit.

A T-VASI25 responder is defined as a participant who has at least 25% improvement from Baseline in the total body vitiligo area scoring index (T-VASI). T-VASI assesses the area of the body affected by vitiligo. The body is divided into 6 regions: head and neck, upper extremities, hands, torso, lower extremities, and feet. For each body region, the 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. T-VASI is derived by summing the values of all body regions, providing a possible range from 0 to 99, with higher scores indicating more severe disease. Participants missing the T-VASI assessment at any visit are imputed as T-VASI25 non-responders for that visit.

A T-VASI35 responder is defined as a participant who has at least 35% improvement from Baseline in the total body vitiligo area scoring index (T-VASI). T-VASI assesses the area of the body affected by vitiligo. The body is divided into 6 regions: head and neck, upper extremities, hands, torso, lower extremities, and feet. For each body region, the 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. T-VASI is derived by summing the values of all body regions, providing a possible range from 0 to 99, with higher scores indicating more severe disease. Participants missing the T-VASI assessment at any visit are imputed as T-VASI35 non-responders for that visit.

A T-VASI50 responder is defined as a participant who has at least 50% improvement from Baseline in the total body vitiligo area scoring index (T-VASI). T-VASI assesses the area of the body affected by vitiligo. The body is divided into 6 regions: head and neck, upper extremities, hands, torso, lower extremities, and feet. For each body region, the 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. T-VASI is derived by summing the values of all body regions, providing a possible range from 0 to 99, with higher scores indicating more severe disease. Participants missing the T-VASI assessment at any visit are imputed as T-VASI50 non-responders for that visit.

A T-VASI75 responder is defined as a participant who has at least 75% improvement from Baseline in the total body vitiligo area scoring index (T-VASI). T-VASI assesses the area of the body affected by vitiligo. The body is divided into 6 regions: head and neck, upper extremities, hands, torso, lower extremities, and feet. For each body region, the 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. T-VASI is derived by summing the values of all body regions, providing a possible range from 0 to 99, with higher scores indicating more severe disease. Participants missing the T-VASI assessment at any visit are imputed as T-VASI75 non-responders for that visit.

A T-VASI90 responder is defined as a participant who has at least 90% improvement from Baseline in the total body vitiligo area scoring index (T-VASI). T-VASI assesses the area of the body affected by vitiligo. The body is divided into 6 regions: head and neck, upper extremities, hands, torso, lower extremities, and feet. For each body region, the 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. T-VASI is derived by summing the values of all body regions, providing a possible range from 0 to 99, with higher scores indicating more severe disease. Participants missing the T-VASI assessment at any visit are imputed as T-VASI90 non-responders for that visit.

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. A negative change from Baseline in the F-VASI signifies improvement. Only participants with available data were analyzed.

T-VASI assesses the area of the body affected by vitiligo. The body is divided into 6 regions: head and neck, upper extremities, hands, torso, lower extremities, and feet. For each body region, the 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. T-VASI is derived by summing the values of all body regions, providing a possible range from 0 to 99, with higher scores indicating more severe disease. A negative change from Baseline in the T-VASI signifies improvement. Only participants with available data were analyzed.

The Vitiligo Extent Score (VES) is a tool for measuring the total body surface area affected by vitiligo. Images are shown of varying extent of vitiligo lesions from least to greatest extent over different body locations. An image from each body location is selected by the investigator during the patient encounter that best reflects the extent to which vitiligo lesions are covering the body surface area (BSA). If lesions are covering an area larger than shown in the last photo, a \>75% but \<100% option can be selected. The online calculator at www.vitiligo-calculator.com will then use selected images to calculate the percentage of the body surface area involved or grade of extent per region (Grade 0 to 6). The VES has a possible range from 0 to 100, with higher scores indicating more severe disease. A negative change from Baseline in the VES signifies improvement. Only participants with available data were analyzed.

The Vitiligo-specific Health-related Quality-of-life Instrument (VitiQoL) is a validated instrument that asks participants to rate various aspects of their vitiligo during the past month. The response to each question will be scored on a 0 (not at all) to 6 (all of the time) scale. The VitiQoL score is calculated as the sum of questions 1 through 15, providing a possible range from 0 to 90, with higher scores indicating more severe disease. A negative change from Baseline in the VitiQoL signifies improvement. Only participants with available data were analyzed.

The Vitiligo Noticeability Scale (VNS) is a validated patient-reported outcome measure of vitiligo treatment where participants will be presented with one pre-treatment photograph of their face and asked to answer the question: "Compared with before treatment, how noticeable is the vitiligo now?". The same pre-treatment photograph must be used at each visit. Scores range from 1 to 5 with a score of 1 being "More noticeable", 2 "As noticeable", 3 "Slightly less noticeable", 4 "A lot less noticeable", and 5 "No longer noticeable". Only participants with available data were analyzed.

The Static Investigator Global Assessment (sIGA) is a 5-point scale that grades the loss of pigmentation and severity of lesions on a participant's body. Lower scores represent lesser extent and lesser severity; higher scores represent greater extent and greater severity. A score of 0 represents clear skin, with no loss of pigmentation after a natural light or Woods lamp examination and a score of 4 represents severe vitiligo, with extensive loss of pigmentation affecting most areas of the body. Only participants with available data were analyzed.

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. A negative percent change from Baseline in the F-VASI signifies improvement. Only participants with available data were analyzed.

T-VASI assesses the area of the body affected by vitiligo. The body is divided into 6 regions: head and neck, upper extremities, hands, torso, lower extremities, and feet. For each body region, the 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. T-VASI is derived by summing the values of all body regions, providing a possible range from 0 to 99, with higher scores indicating more severe disease. A negative percent change from Baseline in the T-VASI signifies improvement. Only participants with available data were analyzed.

A participant who experienced any Grade 2 or higher treatment-emergent adverse event. Includes all ≥ Grade 2 untoward or unfavorable medical occurrence(s) associated with investigational product administration or any study mandated procedures.

A participant who experienced any Grade 3 or higher infectious treatment-emergent adverse event. Includes all ≥ Grade 3 infectious untoward or unfavorable medical occurrence(s).