A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo
NCT ID: NCT06625177
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2024-11-11
2027-06-05
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TEV-53408
solution administered subcutaneously
TEV-53408
TEV-53408 injection administered subcutaneously
Interventions
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TEV-53408
TEV-53408 injection administered subcutaneously
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 12043
Scottsdale, Arizona, United States
Teva Investigational Site 12052
Hot Springs, Arkansas, United States
Teva Investigational Site 12044
Fremont, California, United States
Teva Investigational Site 12051
Irvine, California, United States
Teva Investigational Site 12046
Pasadena, California, United States
Teva Investigational Site 12049
Miramar, Florida, United States
Teva Investigational Site 12047
Chicago, Illinois, United States
Teva Investigational Site 12053
Louisville, Kentucky, United States
Teva Investigational Site 12048
Canton, Michigan, United States
Teva Investigational Site 12054
Portland, Oregon, United States
Teva Investigational Site 12045
Dallas, Texas, United States
Teva Investigational Site 12057
Webster, Texas, United States
Teva Investigational Site 12055
South Jordan, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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TV53408-IMM-10209
Identifier Type: -
Identifier Source: org_study_id