Evaluation of AMG 714 for Vitiligo (REVEAL)

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

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.