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| ID | Type | Description | Link |
|---|---|---|---|
| NIAID CRMS ID#: 38677 | Other Identifier | DAIT NIAID |
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| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
| PPD Development, LP | INDUSTRY |
| Rho Federal Systems Division, Inc. | INDUSTRY |
| Amgen |
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This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.
The primary objective of this trial is to determine the efficacy of interleukin-15 (IL-15) inhibition with AMG 714 at inducing facial repigmentation in vitiligo.
The secondary objectives are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 714 | Biological | anti-IL-15 monoclonal antibody (Anti-IL-15 MAB) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24 | 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Weeks 12, 36, 48. | 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. |
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Individuals must meet all of the following criteria to be eligible for enrollment as study participants:
Adults 18-75 years of age.
Clinical diagnosis of active or stable vitiligo made by a dermatologist, as defined in Protocol Section 3.4.2.
F-VASI ≥ 0.25 (Appendix 2 of Protocol).
T-VASI ≥ 3 (Appendix 2 of Protocol).
Willingness to:
Exclusion Criteria:
Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
Inability or unwillingness of a participant to give written informed consent or comply with the study protocol.
Segmental vitiligo.
Contraindication to nbUVB phototherapy.
More than 33% leukotrichia on the face or on the total body.
Use of biologic immunosuppressive or immunomodulatory agents, or investigational therapy or procedure within 12 weeks or 5 half-lives prior to Visit 0 (whichever is longer), except agents authorized for prevention and treatment of SARS-CoV-2 infection according to FDA Emergency Use Authorization (EUA).
Use of laser or light-based treatment (phototherapy) including tanning beds within 8 weeks prior to Visit 0.
Use of non-biologic systemic or topical immunosuppressive or immunomodulatory agents within 4 weeks prior to Visit 0.
History of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical treatment for vitiligo.
Current or past use of the depigmenting agent monobenzyl ether of hydroquinone, including Benoquin® (Monobenzone).
Presence of skin conditions or lesions that would confound the vitiligo assessments.
Spontaneous repigmentation within 6 months prior to Visit 0 (repigmentation without any treatment and significant in amount as determined by the investigator).
Uncontrolled thyroid function at screening as determined by the investigator. If the participant has a history of thyroid disease and is on treatment, the participant must be on a stable thyroid regimen for at least three months prior to Visit 0.
Greater than 3 adequately treated nonmetastatic basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) within 12 months prior to Visit 0; or previous history of multiple BCC or SCC which may pose additional risks from participation in the study in the opinion of the investigator.
Previous or current diagnosis of other cancer, except adequately treated cervical carcinoma in situ.
Acute or chronic infection, including current use of suppressive therapy for chronic infection, hospitalization for treatment of infection within 90 days prior to Visit 0, or parenteral anti-microbial (including anti-bacterial, anti-viral, or anti-fungal agents) use within 90 days prior to Visit 0.
Evidence of infection, including:
Any of the following laboratory abnormalities:
Women of child-bearing potential who are unwilling to use a medically acceptable form of contraception or be sexually inactive by abstinence until study Week 48 (Protocol Section 7.4). Contraception or abstinence is required for 2 weeks prior to Visit 0.
Women who are pregnant or lactating.
Vaccination with a live attenuated vaccine within 30 days prior to Visit 0.
Known drug allergy or reaction to any component of AMG 714 (Protocol Section 6.1.1) or proteins derived from mammalian cell lines.
Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Current, diagnosed mental illness (e.g. severe depression) or current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
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| Name | Affiliation | Role |
|---|---|---|
| Brett A. King, MD, PhD | Yale University School of Medicine: Department of Dermatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine: Department of Dermatology | Irvine | California | 92697 | United States | ||
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| Label | URL |
|---|---|
| Immune Tolerance Network (ITN) | View source |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| National Institute of Allergy and Infectious Diseases (NIAID) |
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Participant level data access and additional relevant materials will be made available upon completion of the trial.
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After completion of the trial, within 24 months status post database lock.
The Immunology Database and Analysis Portal (ImmPort) is an open access platform for research data sharing and a long-term archive of clinical and mechanistic data, a National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology and Transplantation (NIAID DAIT)-funded data repository. This archive is in support of the NIH mission to share data with the public. Data shared through ImmPort is provided by NIH-funded programs, other research organizations and individual scientists, ensuring these discoveries will be the foundation of future research.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMG 714 | Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. |
| FG001 | Placebo | Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | AMG 714 | Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. |
| BG001 | Placebo | Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Week 24 |
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Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 to Week 48.
Generalized pruritus or urticaria Grade 1 hypersensitivity/anaphylaxis reactions, confirmed Grade 1 SARS-CoV-2 infections, and Grade 2 or higher AEs were recorded in EDC. Safety analyses are based on the safety population, which consists of all participants who receive any amount of AMG 714 or placebo. Participants will be analyzed according to the actual treatment received. One participant randomized to the placebo group received AMG 714.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMG 714 | Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. Any participant receiving at least one injection of AMG 714 at any time during the study will be summarized with the AMG 714 treatment arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2023 | Sep 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2020 | Aug 6, 2025 | ICF_001.pdf |
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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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| ID | Term |
|---|---|
| C000706949 | AMG-714 |
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| INDUSTRY |
Phase 2a, double blind, placebo-controlled, multi-center, proof of concept trial of AMG 714 for the treatment of vitiligo. Participants will be randomized 2:1 to receive AMG 714 or placebo for AMG 714. Random assignment will be stratified by active versus stable vitiligo.
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| Placebo |
| Biological |
Placebo for AMG 714 |
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| 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. |
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| Weeks 12, 36, and 48 |
| Proportion of Participants Achieving a ≥ 25% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI25) at Weeks 12, 24, 36, 48. | 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. | Weeks 12, 24, 36, and 48 |
| Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI50) at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Proportion of Participants Achieving a ≥ 90% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI90) at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Proportion of Participants Achieving a ≥ 25% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI25) at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI35) at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Proportion of Participants Achieving a ≥ 90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Change From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at Weeks 12, 24, 36, 48 | 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. | Baseline; Weeks 12, 24, 36, and 48 |
| Change From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI) at Weeks 12, 24, 36, 48 | 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. | Baseline; Weeks 12, 24, 36, and 48 |
| Change From Baseline in the Vitiligo Extent Score (VES) at Weeks 12, 24, 36, 48 | 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. | Baseline; Weeks 12, 24, 36, and 48 |
| Change From Baseline in the Vitiligo-specific Health-related Quality-of-life Instrument (VitiQoL) Score at Weeks 12, 24, 36, 48 | 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. | Baseline; Weeks 12, 24, 36, and 48 |
| Proportion of Participants in Each Vitiligo Noticeability Scale (VNS) Category at Weeks 12, 24, 36, 48 | 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. | Weeks 12, 24, 36, and 48 |
| Shifts From Baseline in the Distribution of Static Investigator Global Assessment (sIGA) Scores at Weeks 12, 24, 36, 48 | 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. | Baseline; Weeks 12, 24, 36, and 48 |
| Percent Change From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at Weeks 12, 24, 36, 48 | 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. | Baseline; Weeks 12, 24, 36, and 48 |
| Percent Change From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI) at Weeks 12, 24, 36, 48 | 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. | Baseline; Weeks 12, 24, 36, and 48 |
| Proportion of Participants With a Grade 2 or Higher Treatment-Emergent Adverse Event | 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. | Week 0 to Week 24, Week 0 to Week 48 |
| Proportion of Participants With a Grade 3 or Higher Infectious Treatment-Emergent Adverse Event | 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). | Week 0 to Week 24, Week 0 to Week 48 |
| University of California Davis Health System: Department of Dermatology |
| Sacramento |
| California |
| 95816 |
| United States |
| Yale University School of Medicine: Department of Dermatology | New Haven | Connecticut | 06520 | United States |
| Tufts Medical Center: Department of Dermatology | Boston | Massachusetts | 02111 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| NIH health information: Vitiligo | View source |
| Prohibited Medication |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Vitiligo Type at Baseline | Active or stable vitiligo at baseline | Count of Participants | Participants |
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| F-VASI at Baseline | 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. | Mean | Standard Deviation | Score on a Scale |
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| T-VASI at Baseline | 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%. 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. | Mean | Standard Deviation | Score on a Scale |
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| OG000 | AMG 714 | Participants receive 300 mg AMG 714 subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. |
| OG001 | Placebo | Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. |
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| Secondary | Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Weeks 12, 36, 48. | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 25% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI25) at Weeks 12, 24, 36, 48. | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI50) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 90% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI90) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 25% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI25) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI35) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants Achieving a ≥ 90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | 95% Confidence Interval | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Change From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline; Weeks 12, 24, 36, and 48 |
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| Secondary | Change From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI) at Weeks 12, 24, 36, 48 | 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 Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline; Weeks 12, 24, 36, and 48 |
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| Secondary | Change From Baseline in the Vitiligo Extent Score (VES) at Weeks 12, 24, 36, 48 | 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 Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline; Weeks 12, 24, 36, and 48 |
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| Secondary | Change From Baseline in the Vitiligo-specific Health-related Quality-of-life Instrument (VitiQoL) Score at Weeks 12, 24, 36, 48 | 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 Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline; Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants in Each Vitiligo Noticeability Scale (VNS) Category at Weeks 12, 24, 36, 48 | 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 Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | Proportion of participants | Weeks 12, 24, 36, and 48 |
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| Secondary | Shifts From Baseline in the Distribution of Static Investigator Global Assessment (sIGA) Scores at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Number | Proportion of participants | Baseline; Weeks 12, 24, 36, and 48 |
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| Secondary | Percent Change From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline; Weeks 12, 24, 36, and 48 |
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| Secondary | Percent Change From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI) at Weeks 12, 24, 36, 48 | 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. | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline; Weeks 12, 24, 36, and 48 |
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| Secondary | Proportion of Participants With a Grade 2 or Higher Treatment-Emergent Adverse Event | 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. | The Safety population included all participants for whom study treatment was initiated. Safety analyses are based on the actual treatment the participants received. Any participant receiving at least one injection of AMG 714 at any time during the study will be summarized with the AMG 714 treatment arm. One participant randomized to the placebo group received AMG 714. | Posted | Number | Proportion of participants | Week 0 to Week 24, Week 0 to Week 48 |
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| Secondary | Proportion of Participants With a Grade 3 or Higher Infectious Treatment-Emergent Adverse Event | 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). | The Safety population included all participants for whom study treatment was initiated. Safety analyses are based on the actual treatment the participants received. Any participant receiving at least one injection of AMG 714 at any time during the study will be summarized with the AMG 714 treatment arm. One participant randomized to the placebo group received AMG 714. | Posted | Number | Proportion of participants | Week 0 to Week 24, Week 0 to Week 48 |
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| 0 |
| 41 |
| 0 |
| 41 |
| 23 |
| 41 |
| EG001 | Placebo | Participants receive placebo subcutaneously every 2 weeks for 6 doses beginning at Week 0 with the last dose at Week 10. | 0 | 18 | 0 | 18 | 9 | 18 |
| Leukopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
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| Ocular discomfort | Eye disorders | 23.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | 23.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
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| Asthenia | General disorders | 23.1 | Systematic Assessment |
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| Fatigue | General disorders | 23.1 | Systematic Assessment |
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| Hypothermia | General disorders | 23.1 | Systematic Assessment |
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| Influenza like illness | General disorders | 23.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | 23.1 | Systematic Assessment |
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| Gastrointestinal bacterial overgrowth | Infections and infestations | 23.1 | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | 23.1 | Systematic Assessment |
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| Helicobacter infection | Infections and infestations | 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | 23.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | 23.1 | Systematic Assessment |
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| Exposure to toxic agent | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
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| Nail injury | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
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| Radiation injury | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
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| Scapula fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
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| Blood albumin decreased | Investigations | 23.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | 23.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | 23.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | 23.1 | Systematic Assessment |
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| Weight decreased | Investigations | 23.1 | Systematic Assessment |
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| Weight increased | Investigations | 23.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
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| Desmoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
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| Actinic keratosis | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | 23.1 | Systematic Assessment |
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Not provided
Not provided
| Week 48 |
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| Fisher Exact |
| 0.037 |
P-value is from comparing the proportion of F-VASI35 Responders between the two treatment groups using a Fisher's exact test. |
| Superiority |
| Week 48 | Fisher Exact | 0.389 | P-value is from comparing the proportion of F-VASI35 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 36 |
|
| Week 48 |
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| Fisher Exact |
| 0.411 |
P-value is from comparing the proportion of F-VASI25 Responders between the two treatment groups using a Fisher's exact test. |
| Superiority |
| Week 36 | Fisher Exact | 0.275 | P-value is from comparing the proportion of F-VASI25 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 48 | Fisher Exact | 0.785 | P-value is from comparing the proportion of F-VASI25 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 36 |
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| Week 48 |
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| Fisher Exact |
| 0.544 |
P-value is from comparing the proportion of F-VASI50 Responders between the two treatment groups using a Fisher's exact test. |
| Superiority |
| Week 36 | Fisher Exact | 0.044 | P-value is from comparing the proportion of F-VASI50 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 48 | Fisher Exact | 0.565 | P-value is from comparing the proportion of F-VASI50 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 36 |
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| Week 48 |
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| Fisher Exact |
| Superiority |
P-value is from comparing the proportion of F-VASI75 Responders between the two treatment groups using a Fisher's exact test. There were zero F-VASI75 Responders at Week 24 and so a p-value was not applicable for this degenerative case. |
| Week 36 | Fisher Exact | 0.294 | P-value is from comparing the proportion of F-VASI75 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 48 | Fisher Exact | 0.045 | P-value is from comparing the proportion of F-VASI75 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 36 |
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| Week 48 |
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Week 24 |
| Fisher Exact |
| Superiority |
P-value is from comparing the proportion of F-VASI90 Responders between the two treatment groups using a Fisher's exact test. There were zero F-VASI90 Responders at Week 24 and so a p-value was not applicable for this degenerative case. |
| Week 36 | Fisher Exact | 1.000 | P-value is from comparing the proportion of F-VASI90 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 48 | Fisher Exact | 0.544 | P-value is from comparing the proportion of F-VASI90 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 36 |
|
| Week 48 |
|
| Fisher Exact |
| 1.000 |
P-value is from comparing the proportion of T-VASI25 Responders between the two treatment groups using a Fisher's exact test. |
| Superiority |
| Week 36 | Fisher Exact | 0.294 | P-value is from comparing the proportion of T-VASI25 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 48 | Fisher Exact | 0.110 | P-value is from comparing the proportion of T-VASI25 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 36 |
|
| Week 48 |
|
Week 24 |
| Fisher Exact |
| Superiority |
P-value is from comparing the proportion of T-VASI35 Responders between the two treatment groups using a Fisher's exact test. There were zero T-VASI35 Responders at Week 24 and so a p-value was not applicable for this degenerative case. |
| Week 36 | Fisher Exact | 0.544 | P-value is from comparing the proportion of T-VASI35 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 48 | Fisher Exact | 0.011 | P-value is from comparing the proportion of T-VASI35 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 36 |
|
| Week 48 |
|
Week 24 |
| Fisher Exact |
| Superiority |
P-value is from comparing the proportion of T-VASI50 Responders between the two treatment groups using a Fisher's exact test. There were zero T-VASI50 Responders at Week 24 and so a p-value was not applicable for this degenerative case. |
| Week 36 | Fisher Exact | 1.000 | P-value is from comparing the proportion of T-VASI50 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 48 | Fisher Exact | 0.163 | P-value is from comparing the proportion of T-VASI50 Responders between the two treatment groups using a Fisher's exact test. | Superiority |
| Week 36 |
|
| Week 48 |
|
Week 24 |
| Fisher Exact |
| Superiority |
P-value is from comparing the proportion of T-VASI75 Responders between the two treatment groups using a Fisher's exact test. There were zero T-VASI75 Responders at Week 24 and so a p-value was not applicable for this degenerative case. |
| Week 36 | Fisher Exact | Superiority | P-value is from comparing the proportion of T-VASI75 Responders between the two treatment groups using a Fisher's exact test. There were zero T-VASI75 Responders at Week 36 and so a p-value was not applicable for this degenerative case. |
| Week 48 | Fisher Exact | Superiority | P-value is from comparing the proportion of T-VASI75 Responders between the two treatment groups using a Fisher's exact test. There were zero T-VASI75 Responders at Week 48 and so a p-value was not applicable for this degenerative case. |
| Week 36 |
|
| Week 48 |
|
Week 24 |
| Fisher Exact |
| Superiority |
P-value is from comparing the proportion of T-VASI90 Responders between the two treatment groups using a Fisher's exact test. There were zero T-VASI90 Responders at Week 24 and so a p-value was not applicable for this degenerative case. |
| Week 36 | Fisher Exact | Superiority | P-value is from comparing the proportion of T-VASI90 Responders between the two treatment groups using a Fisher's exact test. There were zero T-VASI90 Responders at Week 36 and so a p-value was not applicable for this degenerative case. |
| Week 48 | Fisher Exact | Superiority | P-value is from comparing the proportion of T-VASI90 Responders between the two treatment groups using a Fisher's exact test. There were zero T-VASI90 Responders at Week 48 and so a p-value was not applicable for this degenerative case. |
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| ANCOVA |
| 0.765 |
P-value comes from an analysis of covariance with an outcome of change in F-VASI from Baseline and covariates of treatment and Baseline F-VASI. |
| Superiority |
| Week 36 | ANCOVA | 0.264 | P-value comes from an analysis of covariance with an outcome of change in F-VASI from Baseline and covariates of treatment and Baseline F-VASI. | Superiority |
| Week 48 | ANCOVA | 0.219 | P-value comes from an analysis of covariance with an outcome of change in F-VASI from Baseline and covariates of treatment and Baseline F-VASI. | Superiority |
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| ANCOVA |
| 0.799 |
P-value comes from an analysis of covariance with an outcome of change in T-VASI from Baseline and covariates of treatment and Baseline T-VASI. |
| Superiority |
| Week 36 | ANCOVA | 0.229 | P-value comes from an analysis of covariance with an outcome of change in T-VASI from Baseline and covariates of treatment and Baseline T-VASI. | Superiority |
| Week 48 | ANCOVA | 0.522 | P-value comes from an analysis of covariance with an outcome of change in T-VASI from Baseline and covariates of treatment and Baseline T-VASI. | Superiority |
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| ANCOVA |
| 0.470 |
P-value comes from an analysis of covariance with an outcome of change in VES from Baseline and covariates of treatment and Baseline VES. |
| Superiority |
| Week 36 | ANCOVA | 0.108 | P-value comes from an analysis of covariance with an outcome of change in VES from Baseline and covariates of treatment and Baseline VES. | Superiority |
| Week 48 | ANCOVA | 0.126 | P-value comes from an analysis of covariance with an outcome of change in VES from Baseline and covariates of treatment and Baseline VES. | Superiority |
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| ANCOVA |
| 0.472 |
P-value comes from an analysis of covariance with an outcome of change in VitiQoL from Baseline and covariates of treatment and Baseline VitiQoL. |
| Superiority |
| Week 36 | ANCOVA | 0.930 | P-value comes from an analysis of covariance with an outcome of change in VitiQoL from Baseline and covariates of treatment and Baseline VitiQoL. | Superiority |
| Week 48 | ANCOVA | 0.180 | P-value comes from an analysis of covariance with an outcome of change in VitiQoL from Baseline and covariates of treatment and Baseline VitiQoL. | Superiority |
| Week 12 As noticeable |
|
|
| Week 12 Slightly less noticeable |
|
|
| Week 12 A lot less noticeable |
|
|
| Week 12 No longer noticeable |
|
|
| Week 24 More noticeable |
|
|
| Week 24 As noticeable |
|
|
| Week 24 Slightly less noticeable |
|
|
| Week 24 A lot less noticeable |
|
|
| Week 24 No longer noticeable |
|
|
| Week 36 More noticeable |
|
|
| Week 36 As noticeable |
|
|
| Week 36 Slightly less noticeable |
|
|
| Week 36 A lot less noticeable |
|
|
| Week 36 No longer noticeable |
|
|
| Week 48 More noticeable |
|
|
| Week 48 As noticeable |
|
|
| Week 48 Slightly less noticeable |
|
|
| Week 48 A lot less noticeable |
|
|
| Week 48 No longer noticeable |
|
|
| Fisher Exact |
| 0.185 |
P-value is from comparing the proportion of participants in each category between the two treatment groups using an extension of Fisher's exact test. |
| Superiority |
| Week 36 | Fisher Exact | 0.895 | P-value is from comparing the proportion of participants in each category between the two treatment groups using an extension of Fisher's exact test. | Superiority |
| Week 48 | Fisher Exact | 0.923 | P-value is from comparing the proportion of participants in each category between the two treatment groups using an extension of Fisher's exact test. | Superiority |
| Baseline Almost clear |
|
|
| Baseline Mild vitiligo |
|
|
| Baseline Moderate vitiligo |
|
|
| Baseline Severe vitiligo |
|
|
| Week 12 Clear |
|
|
| Week 12 Almost clear |
|
|
| Week 12 Mild vitiligo |
|
|
| Week 12 Moderate vitiligo |
|
|
| Week 12 Severe vitiligo |
|
|
| Week 24 Clear |
|
|
| Week 24 Almost clear |
|
|
| Week 24 Mild vitiligo |
|
|
| Week 24 Moderate vitiligo |
|
|
| Week 24 Severe vitiligo |
|
|
| Week 36 Clear |
|
|
| Week 36 Almost clear |
|
|
| Week 36 Mild vitiligo |
|
|
| Week 36 Moderate vitiligo |
|
|
| Week 36 Severe vitiligo |
|
|
| Week 48 Clear |
|
|
| Week 48 Almost clear |
|
|
| Week 48 Mild vitiligo |
|
|
| Week 48 Moderate vitiligo |
|
|
| Week 48 Severe vitiligo |
|
|
|
Week 24 |
| Bowker's Test of Symmetry |
| 0.972 |
The p-value comes from Bowker's Test of Symmetry. The null hypothesis tested within each treatment group is that the sIGA categories at Baseline do not differ from the sIGA categories at the given visit. |
| Superiority |
The p-value compares the AMG 714 treatment group at Week 24 to the AMG 714 treatment group at Baseline. |
| Week 36 | Bowker's Test of Symmetry | >0.999 | The p-value comes from Bowker's Test of Symmetry. The null hypothesis tested within each treatment group is that the sIGA categories at Baseline do not differ from the sIGA categories at the given visit. | Superiority | The p-value compares the AMG 714 treatment group at Week 36 to the AMG 714 treatment group at Baseline. |
| Week 48 | Bowker's Test of Symmetry | > 0.999 | The p-value comes from Bowker's Test of Symmetry. The null hypothesis tested within each treatment group is that the sIGA categories at Baseline do not differ from the sIGA categories at the given visit. | Superiority | The p-value compares the AMG 714 treatment group at Week 48 to the AMG 714 treatment group at Baseline. |
| Week 12 | Bowker's Test of Symmetry | 0.947 | The p-value comes from Bowker's Test of Symmetry. The null hypothesis tested within each treatment group is that the sIGA categories at Baseline do not differ from the sIGA categories at the given visit. | Superiority | The p-value compares the placebo treatment group at Week 12 to the placebo treatment group at Baseline. |
| Week 24 | Bowker's Test of Symmetry | 0.947 | The p-value comes from Bowker's Test of Symmetry. The null hypothesis tested within each treatment group is that the sIGA categories at Baseline do not differ from the sIGA categories at the given visit. | Superiority | The p-value compares the placebo treatment group at Week 24 to the placebo treatment group at Baseline. |
| Week 36 | Bowker's Test of Symmetry | 0.981 | The p-value comes from Bowker's Test of Symmetry. The null hypothesis tested within each treatment group is that the sIGA categories at Baseline do not differ from the sIGA categories at the given visit. | Superiority | The p-value compares the placebo treatment group at Week 36 to the placebo treatment group at Baseline. |
| Week 48 | Bowker's Test of Symmetry | 0.947 | The p-value comes from Bowker's Test of Symmetry. The null hypothesis tested within each treatment group is that the sIGA categories at Baseline do not differ from the sIGA categories at the given visit. | Superiority | The p-value compares the placebo treatment group at Week 48 to the placebo treatment group at Baseline. |
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| ANCOVA |
| 0.680 |
P-value comes from an analysis of covariance with an outcome of percent change in F-VASI from Baseline and covariates of treatment and Baseline F-VASI. |
| Superiority |
| Week 36 | ANCOVA | 0.292 | P-value comes from an analysis of covariance with an outcome of percent change in F-VASI from Baseline and covariates of treatment and Baseline F-VASI. | Superiority |
| Week 48 | ANCOVA | 0.482 | P-value comes from an analysis of covariance with an outcome of percent change in F-VASI from Baseline and covariates of treatment and Baseline F-VASI. | Superiority |
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| ANCOVA |
| 0.839 |
P-value comes from an analysis of covariance with an outcome of percent change in T-VASI from Baseline and covariates of treatment and Baseline T-VASI. |
| Superiority |
| Week 36 | ANCOVA | 0.184 | P-value comes from an analysis of covariance with an outcome of percent change in T-VASI from Baseline and covariates of treatment and Baseline T-VASI. | Superiority |
| Week 48 | ANCOVA | 0.105 | P-value comes from an analysis of covariance with an outcome of percent change in T-VASI from Baseline and covariates of treatment and Baseline T-VASI. | Superiority |
Week 0 to Week 48
| Fisher Exact |
| 0.572 |
P-value is from comparing the proportion of participants with at least one Grade 2 or higher treatment-emergent AE between the two treatment groups using a Fisher's exact test. |
| Superiority |
Week 0 to Week 48 |
| Fisher Exact |
| Superiority |
P-value is from comparing the proportion of participants with at least one Grade 3 or higher infectious treatment-emergent AE between the two treatment groups using a Fisher's exact test. There were zero participants with at least one Grade 3 or higher infectious treatment-emergent AE and so a p-value was not applicable for this degenerative case. |