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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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 NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

  • 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 NOTE- Additional criteria apply, please contact the investigator for more information

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TEV-53408 		solution administered subcutaneously
  • Drug: TEV-53408
    TEV-53408 injection administered subcutaneously

Recruiting Locations

Teva Investigational Site 12043
Scottsdale, Arizona 85260

Teva Investigational Site 12052
Hot Springs, Arkansas 71913

Teva Investigational Site 12044
Fremont, California 94538

Teva Investigational Site 12046
Pasadena, California 91101

Teva Investigational Site 12049
Miramar, Florida 33025

Teva Investigational Site 12047
Chicago, Illinois 60614

Teva Investigational Site 12053
Louisville, Kentucky 40421

Teva Investigational Site 12048
Canton, Michigan 48187

Teva Investigational Site 12054
Portland, Oregon 97210

Teva Investigational Site 12045
Dallas, Texas 75230

Teva Investigational Site 12055
South Jordan, Utah 84095

More Details

NCT ID
NCT06625177
Status
Recruiting
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

Study Contact

Teva U.S. Medical Information
1-888-483-8279
USMedInfo@tevapharm.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center