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Evaluation of AMG 714 for Vitiligo (REVEAL)

Primary Purpose

Vitiligo

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AMG 714
Placebo
nbUVB phototherapy
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring efficacy, facial repigmentation, randomized placebo-controlled phase 2a trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must be able to understand and provide informed consent;
  • A clinical diagnosis of active or stable vitiligo made by a dermatologist:

    • Active vitiligo: New or expanding vitiligo lesions with or without the presence of confetti, trichrome, or inflammatory vitiligo lesion patterns or other clinical signs of active vitiligo in the past 3 months
    • Stable vitiligo: No new depigmented lesions, and no confetti, trichrome, or inflammatory vitiligo lesion patterns or other clinical signs of active vitiligo in the past 3 months.
  • Facial Vitiligo Area Scoring Index (F-VASI) ≥ 0.25;
  • Total Body Vitiligo Area Scoring Index (T- VASI) ≥3; and
  • Willingness to:

    • Undergo narrow band ultraviolet B (nbUVB) phototherapy
    • Stop all other treatments for vitiligo from screening through the final follow up visit at week 48.

Exclusion Criteria:

  • Inability or unwillingness of a participant to give written informed consent or comply with the study protocol;
  • Diagnosis of segmental vitiligo;
  • Contraindication to narrow band ultraviolet B (nbUVB) phototherapy;
  • More than 33% leukotrichia on the face or on the total body;
  • Use of biologic, investigational, or experimental therapy or procedure within 12 weeks or 5 half-lives prior to Visit 0 (whichever is longer);
  • 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 (e.g., repigmentation without any treatment, and significant in amount as determined by the investigator);
  • Uncontrolled thyroid function at screening as determined by the investigator:

    --Note: 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 a 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, with the exception of 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 use within 90 days prior to Visit 0 (including anti-bacterial, anti-viral, or anti-fungal agents).
  • 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), or
    • Positive QuantiFERON-tuberculosis (TB) Gold or QuantiFERON-TB Gold Plus test ---Note: Purified protein derivative (PPD) skin 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) ≥ Twice the Upper Limit of Normal (ULN)
    • Aspartate aminotransferase (AST) ≥ Twice the Upper Limit of Normal (ULN).
  • Women of child-bearing potential who are unwilling to use a medically acceptable form of contraception until study Week 48.

    --Note: Contraception is required for 2 weeks prior to Visit 0 through Week 48 of study participation.

  • 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 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, or
  • Current, diagnosed mental illness (e.g. severe depression for example) 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.

Sites / Locations

  • University of California, Irvine: Department of DermatologyRecruiting
  • University of California Davis Health System: Department of DermatologyRecruiting
  • Yale University School of Medicine: Department of DermatologyRecruiting
  • Tufts Medical Center: Department of DermatologyRecruiting
  • University of Massachusetts Medical SchoolRecruiting
  • Henry Ford Health SystemRecruiting
  • Northwell HealthRecruiting
  • Perelman School of Medicine, University of Pennsylvania: Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMG 714

Placebo

Arm Description

Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).

Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).

Outcomes

Primary Outcome Measures

Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 24
≥35% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.

Secondary Outcome Measures

Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 12, Week 36, Week 48
≥35% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥25 (F-VASI25) at Week 12, Week 24, Week 36 and Week 48
≥25% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥50 (F-VASI50) at Week 12, Week 24, Week 36 and Week 48
≥50% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥75 (F-VASI75) at Week 12, Week 24, Week 36 and Week 48
≥75% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥90 (F-VASI90) at Week 12, Week 24, Week 36 and Week 48
≥90% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥25 (T-VASI25) at Week 12, Week 24, Week 36 and Week 48
≥ 25% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥35 (T-VASI35) at Week 12, Week 24, Week 36 and Week 48
≥ 35% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥50 (T-VASI50) at Week 12, Week 24, Week 36 and Week 48
≥ 50% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥75 (T-VASI75) at Week 12, Week 24, Week 36 and Week 48
≥ 75% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥90 (T-VASI90) at Week 12, Week 24, Week 36 and Week 48
≥ 90% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48
The Face Vitiligo Area Scoring Index (F-VASI) measures the amount of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%), measured by a clinician using the palmar method.
Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48
The total body Vitiligo Area Scoring Index (T-VASI) is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet). Assessments are conducted by a clinician.
Change from Baseline (Day 0) in Vitiligo Extent Score (VES) at Week 12, Week 24, Week 36, and Week 48
The Vitiligo Extent Score (VES) is a measurement of the overall vitiligo involvement of the body (extent) and is used by clinicians for the assessment of disease activity. Methodology: Using the VES calculator ( www.vitiligo-calculator.com) , the clinician chooses the pictures that best represent the participant's skin lesions, then the percentage of depigmented area is calculated.
Change from Baseline (Day 0) in the Vitiligo Quality of Life (VitiQoL) at Week 12, Week 24, Week 36, and Week 48
The Vitiligo Quality of Life instrument (VitiQoL) is a validated instrument comprised of sixteen questions on a 7 point Likert scale that asks participants to rate aspects of their vitiligo during the past month (Range for each question: An answer of "Not at all" to "All of the Time.").
Change from Baseline (Day 0) in the Vitiligo Noticeability Scale (VNS) at Week 12, Week 24, Week 36, and Week 48
The Vitiligo Noticeability Scale (VNS) is a validated patient-reported outcome measure of vitiligo treatment. Participants will be shown a pre-treatment photograph of their face and asked to answer the question, "Compared with before treatment, how noticeable is the vitiligo now?" There are five Response Options (Score). Success criteria are pre-defined.
Percentage Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48
The Face Vitiligo Area Scoring Index (F-VASI) measures the percentage of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%), measured by a clinician using the palmar method.
Percentage Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48
The total body Vitiligo Area Scoring Index (T-VASI) is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet). Assessments are conducted by a clinician.
Occurrence of ≥ Grade 2 Adverse Events (AEs)
Includes all ≥ Grade 2 untoward or unfavorable medical occurrence(s) associated with investigational product administration and/ or any study mandated procedures.
Occurrence of ≥ Grade 3 Infectious Adverse Events (AEs)
Includes all ≥ Grade 3 infectious untoward or unfavorable medical occurrence(s).

Full Information

First Posted
April 6, 2020
Last Updated
April 19, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN), PPD, Rho Federal Systems Division, Inc., Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04338581
Brief Title
Evaluation of AMG 714 for Vitiligo
Acronym
REVEAL
Official Title
Evaluation of AMG 714 for Vitiligo: A Phase 2a Randomized Double Blind Placebo Controlled Trial (ITN086AI)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN), PPD, Rho Federal Systems Division, Inc., Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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, and Evaluate the efficacy of AMG 714 followed by narrow band UVB (nbUVB) phototherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
efficacy, facial repigmentation, randomized placebo-controlled phase 2a trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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 AMG714. Random assignment will be stratified by active versus stable vitiligo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AMG 714
Arm Type
Experimental
Arm Description
Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).
Intervention Type
Biological
Intervention Name(s)
AMG 714
Intervention Description
anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo for AMG 714
Intervention Type
Procedure
Intervention Name(s)
nbUVB phototherapy
Other Intervention Name(s)
narrow band ultraviolet B phototherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 24
Description
≥35% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 12, Week 36, Week 48
Description
≥35% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Time Frame
Week 12, Week 36, Week 48
Title
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥25 (F-VASI25) at Week 12, Week 24, Week 36 and Week 48
Description
≥25% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥50 (F-VASI50) at Week 12, Week 24, Week 36 and Week 48
Description
≥50% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥75 (F-VASI75) at Week 12, Week 24, Week 36 and Week 48
Description
≥75% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥90 (F-VASI90) at Week 12, Week 24, Week 36 and Week 48
Description
≥90% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥25 (T-VASI25) at Week 12, Week 24, Week 36 and Week 48
Description
≥ 25% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥35 (T-VASI35) at Week 12, Week 24, Week 36 and Week 48
Description
≥ 35% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥50 (T-VASI50) at Week 12, Week 24, Week 36 and Week 48
Description
≥ 50% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥75 (T-VASI75) at Week 12, Week 24, Week 36 and Week 48
Description
≥ 75% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥90 (T-VASI90) at Week 12, Week 24, Week 36 and Week 48
Description
≥ 90% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Time Frame
Week 12, Week 24, Week 36, Week 48
Title
Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48
Description
The Face Vitiligo Area Scoring Index (F-VASI) measures the amount of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%), measured by a clinician using the palmar method.
Time Frame
Week 12, Week 24, Week 36, and Week 48
Title
Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48
Description
The total body Vitiligo Area Scoring Index (T-VASI) is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet). Assessments are conducted by a clinician.
Time Frame
Week 12, Week 24, Week 36, and Week 48
Title
Change from Baseline (Day 0) in Vitiligo Extent Score (VES) at Week 12, Week 24, Week 36, and Week 48
Description
The Vitiligo Extent Score (VES) is a measurement of the overall vitiligo involvement of the body (extent) and is used by clinicians for the assessment of disease activity. Methodology: Using the VES calculator ( www.vitiligo-calculator.com) , the clinician chooses the pictures that best represent the participant's skin lesions, then the percentage of depigmented area is calculated.
Time Frame
Week 12, Week 24, Week 36, and Week 48
Title
Change from Baseline (Day 0) in the Vitiligo Quality of Life (VitiQoL) at Week 12, Week 24, Week 36, and Week 48
Description
The Vitiligo Quality of Life instrument (VitiQoL) is a validated instrument comprised of sixteen questions on a 7 point Likert scale that asks participants to rate aspects of their vitiligo during the past month (Range for each question: An answer of "Not at all" to "All of the Time.").
Time Frame
Week 12, Week 24, Week 36, and Week 48
Title
Change from Baseline (Day 0) in the Vitiligo Noticeability Scale (VNS) at Week 12, Week 24, Week 36, and Week 48
Description
The Vitiligo Noticeability Scale (VNS) is a validated patient-reported outcome measure of vitiligo treatment. Participants will be shown a pre-treatment photograph of their face and asked to answer the question, "Compared with before treatment, how noticeable is the vitiligo now?" There are five Response Options (Score). Success criteria are pre-defined.
Time Frame
Week 12, Week 24, Week 36, and Week 48
Title
Percentage Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48
Description
The Face Vitiligo Area Scoring Index (F-VASI) measures the percentage of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%), measured by a clinician using the palmar method.
Time Frame
Week 12, Week 24, Week 36, and Week 48
Title
Percentage Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48
Description
The total body Vitiligo Area Scoring Index (T-VASI) is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet). Assessments are conducted by a clinician.
Time Frame
Week 12, Week 24, Week 36, and Week 48
Title
Occurrence of ≥ Grade 2 Adverse Events (AEs)
Description
Includes all ≥ Grade 2 untoward or unfavorable medical occurrence(s) associated with investigational product administration and/ or any study mandated procedures.
Time Frame
Up to Week 48
Title
Occurrence of ≥ Grade 3 Infectious Adverse Events (AEs)
Description
Includes all ≥ Grade 3 infectious untoward or unfavorable medical occurrence(s).
Time Frame
Up to Week 48
Other Pre-specified Outcome Measures:
Title
EXPLORATORY: Time-to-Event Analysis of Participants Who Achieve total body Vitiligo Area Scoring Index ≥35 (T-VAS135)
Description
Participants who achieve ≥ 35% improvement in full body assessment of Vitiligo Area and Severity Index (T-VASI). The time-to-event data will be summarized using the Kaplan-Meier method. The T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet). Assessments are conducted by a clinician.
Time Frame
Up to 48 Weeks
Title
EXPLORATORY: Time-to-Event Analysis of Participants Who Achieve a F-VASI35
Description
Participants who achieve ≥ 35% improvement in Face Vitiligo Area Scoring Index (F-VASI) score. The time-to-event data will be summarized using the Kaplan-Meier method. The F-VASI measures the amount of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%), measured by a clinician using the palmar method.
Time Frame
Up to 48 Weeks
Title
EXPLORATORY: AMG 714 Serum Levels
Description
Level of study product AMG 714 measured in the blood (serum) of participants.
Time Frame
Week 6, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Section 3.4.2. F-VASI ≥ 0.25 (Appendix 2). T-VASI ≥ 3 (Appendix 2). Completion of SARS-CoV-2 primary vaccination series ≥ 14 days prior to randomization (Day 0). Willingness to: Undergo nbUVB phototherapy, as outlined in Section 7.3. Stop all other treatments for vitiligo from screening through the final follow up visit as outlined in Section 7.2. Exclusion Crieteria: 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: 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 103/μL Hemoglobin < 10 g/dL Platelets (Plt) < 125,000/mm3 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 (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 (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. Completion of a SARS-CoV-2 vaccination series is required for all participants prior to randomization (Section 4.2). Booster immunizations are strongly recommended for all participants eligible to receive them.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett A. King, MD, PhD
Organizational Affiliation
Yale University School of Medicine: Department of Dermatology
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Irvine: Department of Dermatology
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Ortiz
Phone
714-308-4124
Email
ulloal@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Anand Ganesan, MD, PhD
Facility Name
University of California Davis Health System: Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iryna Rybak
Phone
916-551-2636
Email
irybak@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Victor Huang, MD
Facility Name
Yale University School of Medicine: Department of Dermatology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea DeClement
Phone
203-785-5182
Email
andrea.declement@yale.edu
First Name & Middle Initial & Last Name & Degree
Brett A. King, MD, PhD
Facility Name
Tufts Medical Center: Department of Dermatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Donovan
Phone
617-636-7462
Email
ndonovan1@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
David Rosmarin, MD
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celia Hartigan
Phone
508-856-7698
Email
Celia.Hartigan@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Medhi Rashighi
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Miller
Phone
313-916-6964
Email
amiller5@hfhs.org
First Name & Middle Initial & Last Name & Degree
Iltefat Hamzavi, MD
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabah Iqbal
Phone
516-881-7026
Email
siqbal14@northwell.edu
First Name & Middle Initial & Last Name & Degree
George Han
Facility Name
Perelman School of Medicine, University of Pennsylvania: Department of Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan C. Taylor, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant level data access and additional relevant materials will be made available upon completion of the trial.
IPD Sharing Time Frame
After completion of the trial, within 24 months status post database lock.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://www.immport.org/home
Links:
URL
http://www.immunetolerance.org/
Description
Immune Tolerance Network (ITN)
URL
https://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT)
URL
https://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID)
URL
https://www.niams.nih.gov/health-topics/vitiligo
Description
NIH health information: Vitiligo

Learn more about this trial

Evaluation of AMG 714 for Vitiligo

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