VitiligoPhase 2REVEALNCT04338581
Evaluation of AMG 714 for Vitiligo
A Phase 2 study testing AMG 714 and nbUVB phototherapy in people with Vitiligo, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial summary
This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- AMG 714 and nbUVB phototherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Dec 2020to 2 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
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- 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:
- Human immunodeficiency virus (HIV)
- Current or prior infection with hepatitis B (HBV), as indicated by positive HBsAg or positive HBcAb
- Current or prior hepatitis C (HCV), unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 12 weeks after cessation of therapy)
- Positive Quantiferon-TB Gold or Quantiferon-TB Gold Plus test. PPD or T-SPOT.TB test may be substituted for Quantiferon-TB Gold or Quantiferon-TB Gold Plus test
- Any of the following laboratory abnormalities:
- White blood count (WBC) < 3.5 x 10^3/μL
- Hemoglobin < 10 g/dL
- Platelets (Plt) < 125,000/mm^3
- Alanine aminotransferase (ALT) ≥ 2x ULN
- Aspartate aminotransferase (AST) ≥ 2x ULN
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Tufts Medical Center: Department of Dermatology
Boston, Massachusetts, 02111
Henry Ford Health System
Detroit, Michigan, 48202
University of California, Irvine: Department of Dermatology
Irvine, California, 92697
Northwell Health
Lake Success, New York, 11042
Yale University School of Medicine: Department of Dermatology
New Haven, Connecticut, 06520
University of California Davis Health System: Department of Dermatology
Sacramento, California, 95816
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
About this study
Official title: Evaluation of AMG 714 for Vitiligo: A Phase 2a Randomized Double Blind Placebo Controlled Trial (ITN086AI)
This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.
Read the detailed description
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:
- Evaluate the safety and tolerability of AMG 714 in vitiligo
- Determine the efficacy of IL-15 inhibition with AMG 714 at inducing total body skin repigmentation in vitiligo
- Assess the durability of the skin repigmentation achieved by AMG 714 in vitiligo
- Evaluate the efficacy of AMG 714 followed by narrow band UVB (nbUVB) phototherapy
- Conditions
- Vitiligo
- Being tested
- AMG 714, Placebo, nbUVB phototherapy
- Keywords
- efficacy, facial repigmentation, randomized placebo-controlled phase 2a trial
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 714Biological
anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)
PlaceboBiological
Placebo for AMG 714
nbUVB phototherapyProcedure or surgery
Also called narrow band ultraviolet B phototherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: AMG 714; Procedure: nbUVB phototherapy |
| 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). Receives: Biological: Placebo; Procedure: nbUVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Week 0 to Week 24, Week 0 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start11 Dec 2020
- Primary completion16 Oct 2024
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc., Amgen
- Responsible party
- Sponsor
- Investigators
- Brett A. King, MD, PhD, Study chair, Yale University School of Medicine: Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338581
- Sponsor's protocol ID
- DAIT ITN086AI
- Other IDs
- NIAID CRMS ID#: 38677
- Acronym
- REVEAL
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2020
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant level data access and additional relevant materials will be made available upon completion of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of AMG 714 for Vitiligo: A Phase 2a Randomized Double Blind Placebo Controlled Trial (ITN086AI)
- ClinicalTrials.gov ID
- NCT04338581
- Acronym / sponsor ID
- REVEAL / DAIT ITN086AI
- Conditions
- Vitiligo
- Keywords
- efficacy, facial repigmentation, randomized placebo-controlled phase 2a trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc., Amgen
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.
Detailed description
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:
- Evaluate the safety and tolerability of AMG 714 in vitiligo
- Determine the efficacy of IL-15 inhibition with AMG 714 at inducing total body skin repigmentation in vitiligo
- Assess the durability of the skin repigmentation achieved by AMG 714 in vitiligo
- Evaluate the efficacy of AMG 714 followed by narrow band UVB (nbUVB) phototherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AMG 714 | Experimental | Biological: AMG 714, Procedure: nbUVB phototherapyParticipants will be administered 300 mg AMG 714 beginning at Week 0 and every 2 weeks thereafter through Week 10 (for a total of 6 doses). Each dose will be administered as 2 subcutaneous injections (1.5 mL each). |
| Placebo | Placebo comparator | Biological: Placebo, Procedure: nbUVB phototherapyParticipants 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 714anti-IL-15 monoclonal antibody (Anti-IL-15 MAB) | Biological | AMG 714 |
| PlaceboPlacebo for AMG 714 | Biological | Placebo |
| nbUVB phototherapyAlso: narrow band ultraviolet B phototherapyParticipants 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. | Procedure or surgery | AMG 714, Placebo |
Primary outcome
Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24
Time frame: 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.
20 secondary outcomes
Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Weeks 12, 36, 48.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weeks 12, 24, 36, and 48
Change From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at Weeks 12, 24, 36, 48
Time frame: 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
Time frame: Baseline; Weeks 12, 24, 36, and 48
Change From Baseline in the Vitiligo Extent Score (VES) at Weeks 12, 24, 36, 48
Time frame: 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
Time frame: Baseline; Weeks 12, 24, 36, and 48
Proportion of Participants in Each Vitiligo Noticeability Scale (VNS) Category at Weeks 12, 24, 36, 48
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline; Weeks 12, 24, 36, and 48
Proportion of Participants With a Grade 2 or Higher Treatment-Emergent Adverse Event
Time frame: Week 0 to Week 24, Week 0 to Week 48
Proportion of Participants With a Grade 3 or Higher Infectious Treatment-Emergent Adverse Event
Time frame: Week 0 to Week 24, Week 0 to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- NIH health information: VitiligoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data access and additional relevant materials will be made available upon completion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett A. King, MD, PhD study chair
Yale University School of Medicine: Department of Dermatology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 714 and nbUVB phototherapy in people with Vitiligo, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.