A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo

Description

The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with vitiligo. A secondary objective is to further evaluate the safety of TEV-53408. The planned study period per participant is 84 weeks including a screening period (up to 4 weeks), a 24-week open-label treatment period, a 16-week washout period, and a 40-week follow-up period.

Conditions

Vitiligo

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Study Overview

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Study Details

Study overview

The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with vitiligo. A secondary objective is to further evaluate the safety of TEV-53408. The planned study period per participant is 84 weeks including a screening period (up to 4 weeks), a 24-week open-label treatment period, a 16-week washout period, and a 40-week follow-up period.

A Phase 1b, Open-Label Trial to Assess Safety and Exploratory Efficacy of TEV-53408 in Participants With Vitiligo

A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo

Condition
Vitiligo
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Teva Investigational Site 12043, Scottsdale, Arizona, United States, 85260

Hot Springs

Teva Investigational Site 12052, Hot Springs, Arkansas, United States, 71913

Fremont

Teva Investigational Site 12044, Fremont, California, United States, 94538

Pasadena

Teva Investigational Site 12046, Pasadena, California, United States, 91101

Miramar

Teva Investigational Site 12049, Miramar, Florida, United States, 33025

Chicago

Teva Investigational Site 12047, Chicago, Illinois, United States, 60614

Louisville

Teva Investigational Site 12053, Louisville, Kentucky, United States, 40421

Canton

Teva Investigational Site 12048, Canton, Michigan, United States, 48187

Portland

Teva Investigational Site 12054, Portland, Oregon, United States, 97210

Dallas

Teva Investigational Site 12045, Dallas, Texas, United States, 75230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * The participant has a diagnosis of active or stable vitiligo for at least 3 months.
  • * The participant has a body mass index (BMI) within the range of 18.5 to 40.0 kg/m2
  • * A female participant is eligible if she is not pregnant or breastfeeding AND is a woman of nonchildbearing potential OR is a women of childbearing potential using a contraceptive method that is highly effective AND agrees not to donate eggs for the purpose of reproduction for the required period
  • * A male participant is eligible if he agrees to refrain from donating sperm PLUS remain abstinent from heterosexual intercourse OR use a male condom with a female partner for the required period
  • * The participant is capable of giving signed, informed consent
  • * The participant agrees to discontinue all agents and procedures used to treat vitiligo during the treatment period in the trial
  • * If receiving permitted concomitant medications for any reason other than vitiligo, the participant must be on a stable regimen,
  • * The participant must agree to avoid prolonged exposure to the sun, must use sunscreen, and must not use tanning booths, sun lamps, or other ultraviolet light sources
  • * The participant suffers from vitiligo induced by exposure to chemicals or immunotherapy known to induce vitiligo
  • * The participant has other autoimmune diseases for which systemic immunotherapy is or may be warranted
  • * The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding fully-treated basal cell carcinoma
  • * Infectious disease
  • * The participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas
  • * The participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo. After 2 or more years since last melanocyte-keratinocyte transplantation procedure, the participants may be included in the trial.
  • * The participant has donated or received any blood or blood products (white blood cells, platelets, etc) within the 60 days prior to screening or has donated blood or blood products on 2 or more occasions within the 6 months prior to IMP administration, or has donated plasma within 7 days before the screening visit, or has planned donations during the trial
  • * The participant has current or history of alcohol or other substance abuse

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Teva Branded Pharmaceutical Products R&D, Inc.,

Teva Medical Expert, MD, STUDY_DIRECTOR, Teva Branded Pharmaceutical Products R&D, Inc.

Study Record Dates

2027-06-05