Evaluation of AMG 714 for Vitiligo
a study on Vitiligo
This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.
Evaluation of AMG 714 for Vitiligo: A Phase 2a Randomized Double Blind Placebo Controlled Trial (ITN086AI)
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.
Vitiligo efficacy facial repigmentation randomized placebo-controlled phase 2a trial AMG 714 nbUVB phototherapy
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.
- University of California, Irvine: Department of Dermatology
accepting new patients
Irvine California 92697 United States
- University of California Davis Health System: Department of Dermatology
accepting new patients
Sacramento California 95816 United States
Lead Scientist at UC Irvine
- Anand Ganesan, MD, PhD
Professor, Dermatology. Authored (or co-authored) 32 research publications.
- accepting new patients
- Start Date
- Completion Date
- National Institute of Allergy and Infectious Diseases (NIAID)
- Immune Tolerance Network (ITN) Division of Allergy, Immunology, and Transplantation (DAIT) National Institute of Allergy and Infectious Diseases (NIAID) NIH health information: Vitiligo
- Phase 2
- Study Type
- Last Updated
Please contact me about this study
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The study team should get back to you in a few business days.