Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

Evaluation of AMG 714 for Vitiligo: A Phase 2a Randomized Double Blind Placebo Controlled Trial (ITN086AI)

Keywords

Vitiligo efficacy facial repigmentation randomized placebo-controlled phase 2a trial AMG 714 nbUVB phototherapy

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • 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 103/µL

  • Hemoglobin <10 g/dL
  • Platelets (Plt) < 125,000/mm3

  • 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.

Locations

  • University of California, Irvine: Department of Dermatology
    Irvine California 92697 United States
  • Vitiligo and Pigmentation Institute of Southern California
    Los Angeles California 90036 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
Immune Tolerance Network (ITN) Division of Allergy, Immunology, and Transplantation (DAIT) National Institute of Allergy and Infectious Diseases (NIAID) NIH health information: Vitiligo
ID
NCT04338581
Phase
Phase 2
Study Type
Interventional
Last Updated