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Evaluation of AMG 714 for Vitiligo (REVEAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338581
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : April 14, 2021
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
PPD
Rho Federal Systems Division, Inc.
Amgen
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.

Condition or disease Intervention/treatment Phase
Vitiligo Biological: AMG 714 Biological: Placebo Procedure: nbUVB phototherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of AMG 714 for Vitiligo: A Phase 2a Randomized Double Blind Placebo Controlled Trial (ITN086AI)
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: AMG 714
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).
Biological: AMG 714
anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)

Procedure: nbUVB 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.
Other Name: narrow band ultraviolet B phototherapy

Placebo Comparator: Placebo
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).
Biological: Placebo
Placebo for AMG 714

Procedure: nbUVB 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.
Other Name: narrow band ultraviolet B phototherapy




Primary Outcome Measures :
  1. Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 24 [ Time Frame: Week 24 ]
    ≥35% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.


Secondary Outcome Measures :
  1. Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 12, Week 36, Week 48 [ Time Frame: Week 12, Week 36, Week 48 ]
    ≥35% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.

  2. Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥25 (F-VASI25) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥25% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.

  3. Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥50 (F-VASI50) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥50% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.

  4. Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥75 (F-VASI75) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥75% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.

  5. Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥90 (F-VASI90) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥90% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.

  6. Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥25 (T-VASI25) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥ 25% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)

  7. Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥35 (T-VASI35) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥ 35% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)

  8. Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥50 (T-VASI50) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥ 50% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)

  9. Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥75 (T-VASI75) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥ 75% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)

  10. Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥90 (T-VASI90) at Week 12, Week 24, Week 36 and Week 48 [ Time Frame: Week 12, Week 24, Week 36, Week 48 ]
    ≥ 90% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)

  11. Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48 [ Time Frame: 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.

  12. Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48 [ Time Frame: 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.

  13. Change from Baseline (Day 0) in Vitiligo Extent Score (VES) at Week 12, Week 24, Week 36, and Week 48 [ Time Frame: 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.

  14. Change from Baseline (Day 0) in the Vitiligo Quality of Life (VitiQoL) at Week 12, Week 24, Week 36, and Week 48 [ Time Frame: 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.").

  15. Change from Baseline (Day 0) in the Vitiligo Noticeability Scale (VNS) at Week 12, Week 24, Week 36, and Week 48 [ Time Frame: 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.


  16. Percentage Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48 [ Time Frame: 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.

  17. 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 [ Time Frame: 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.

  18. Occurrence of ≥ Grade 2 Adverse Events (AEs) [ Time Frame: Up to Week 48 ]
    Includes all ≥ Grade 2 untoward or unfavorable medical occurrence(s) associated with investigational product administration and/ or any study mandated procedures.

  19. Occurrence of ≥ Grade 3 Infectious Adverse Events (AEs) [ Time Frame: Up to Week 48 ]
    Includes all ≥ Grade 3 infectious untoward or unfavorable medical occurrence(s).


Other Outcome Measures:
  1. EXPLORATORY: Time-to-Event Analysis of Participants Who Achieve total body Vitiligo Area Scoring Index ≥35 (T-VAS135) [ Time Frame: Up to 48 Weeks ]

    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.


  2. EXPLORATORY: Time-to-Event Analysis of Participants Who Achieve a F-VASI35 [ Time Frame: Up to 48 Weeks ]

    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.


  3. EXPLORATORY: AMG 714 Serum Levels [ Time Frame: Week 6, Week 12 ]
    Level of study product AMG 714 measured in the blood (serum) of participants.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338581


Locations
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United States, California
University of California, Irvine: Department of Dermatology Recruiting
Irvine, California, United States, 92697
Contact: Narinder Singh    949-824-6483    narins1@hs.uci.edu   
Principal Investigator: Anand Ganesan, MD, PhD         
Vitiligo and Pigmentation Institute of Southern California Withdrawn
Los Angeles, California, United States, 90036
University of California Davis Health System: Department of Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Iryna Rybak    916-551-2636    irybak@ucdavis.edu   
Principal Investigator: Victor Huang, MD         
United States, Connecticut
Yale University School of Medicine: Department of Dermatology Recruiting
New Haven, Connecticut, United States, 06824
Contact: Andrea DeClement    203-785-5182    andrea.declement@yale.edu   
Principal Investigator: Brett A. King, MD, PhD         
United States, Massachusetts
Tufts Medical Center: Department of Dermatology Not yet recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: David Rosmarin, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Angela Miller    313-916-6964    amiller5@hfhs.org   
Principal Investigator: Iltefat Hamzavi, MD         
United States, Pennsylvania
Perelman School of Medicine, University of Pennsylvania: Department of Dermatology Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Susan C. Taylor, MD         
United States, Texas
University of Texas at Austin: Department of Dermatology Not yet recruiting
Austin, Texas, United States, 78701
Principal Investigator: Ammar M. Ahmed, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
PPD
Rho Federal Systems Division, Inc.
Amgen
Investigators
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Study Chair: Brett A. King, MD, PhD Yale University School of Medicine: Department of Dermatology
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04338581    
Other Study ID Numbers: DAIT ITN086AI
NIAID CRMS ID#: 38677 ( Other Identifier: DAIT NIAID )
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data access and additional relevant materials will be made available upon completion of the trial.
Time Frame: After completion of the trial, within 24 months status post database lock.
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.
URL: https://www.immport.org/home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
efficacy
facial repigmentation
randomized placebo-controlled phase 2a trial
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases