Trial · NCT04338581
Evaluation of AMG 714 for Vitiligo
NCT04338581, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2025-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of AMG 714 for Vitiligo. Trials, record NCT04338581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04338581
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of AMG 714 for Vitiligo
- NCT number
- NCT04338581
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Vitiligo
- Interventions
- AMG 714, Placebo, nbUVB phototherapy
- First posted
- 2020-04-08
- Last updated
- 2026-04-21
- Results first posted
- 2025-11-17
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24 | 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. |
| Secondary | Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Weeks 12, 36, 48. | Weeks 12, 36, and 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. |
| 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. | Weeks 12, 24, 36, and 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. |
| 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 | Weeks 12, 24, 36, and 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. |
| 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 | Weeks 12, 24, 36, and 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. |
| 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 | Weeks 12, 24, 36, and 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. |
| 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 | Weeks 12, 24, 36, and 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. |
| 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 | Weeks 12, 24, 36, and 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. |
| 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 | Weeks 12, 24, 36, and 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. |
| 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 | Weeks 12, 24, 36, and 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24 | Week 24 | The Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of either AMG 714 or placebo. | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24 | AMG 714 | 0.150 | 95% Confidence Interval 0.057 to 0.298 | Proportion of participants | |
| Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24 | Placebo | 0.053 | 95% Confidence Interval 0.001 to 0.260 | Proportion of participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AMG 714 | 40 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | Received AMG 714 | AMG 714 | 40 | |
| Overall Study | Received AMG 714 | Placebo | 1 | |
| Overall Study | Received Placebo | AMG 714 | 0 | |
| Overall Study | Received Placebo | Placebo | 19 | |
| Overall Study | COMPLETED | AMG 714 | 34 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | AMG 714 | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | AMG 714 | 0 | 41 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 18 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | AMG 714 | 1 | 41 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 0 | 18 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | AMG 714 | 3 | 41 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 1 | 18 | 1 |
| other | Ocular discomfort | Eye disorders | AMG 714 | 1 | 41 | 1 |
| other | Ocular discomfort | Eye disorders | Placebo | 0 | 18 | 0 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | AMG 714 | 1 | 41 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 0 | 18 | 0 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AMG 714 | 0 | 41 |
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, other adverse events | AMG 714 | 23 | 41 |
| Total, other adverse events | Placebo | 9 | 18 |
| Total, serious adverse events | AMG 714 | 0 | 41 |
| Total, serious adverse events | Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AMG 714 vs Placebo: deaths from any cause | Trial comparisons |
| AMG 714 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04338581
GET https://conductscience.org/api/trials/v1/NCT04338581/registered?page=2