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

August 26, 2026 updated by: Teva Branded Pharmaceutical Products R&D LLC

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

The purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Teva Investigational Site 12043
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Teva Investigational Site 12052
    • California
      • Fremont, California, United States, 94538
        • Teva Investigational Site 12044
      • Irvine, California, United States, 92617
        • Teva Investigational Site 12051
      • Pasadena, California, United States, 91101
        • Teva Investigational Site 12046
    • Florida
      • Miramar, Florida, United States, 33025
        • Teva Investigational Site 12049
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Teva Investigational Site 12047
    • Kentucky
      • Louisville, Kentucky, United States, 40421
        • Teva Investigational Site 12053
    • Michigan
      • Canton, Michigan, United States, 48187
        • Teva Investigational Site 12048
    • Oregon
      • Portland, Oregon, United States, 97210
        • Teva Investigational Site 12054
    • Texas
      • Dallas, Texas, United States, 75230
        • Teva Investigational Site 12045
      • Webster, Texas, United States, 77598
        • Teva Investigational Site 12057
    • Utah
      • South Jordan, Utah, United States, 84095
        • Teva Investigational Site 12055

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Dose A
Drug: TEV-53408
TEV-53408 injection administered subcutaneously
Experimental: Cohort 2
Dose A
Drug: TEV-53408
TEV-53408 injection administered subcutaneously
Experimental: Cohort 3
Dose B
Drug: TEV-53408
TEV-53408 injection administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With at Least One Treatment-Emergent Adverse Event
Time Frame: Up to Week 40
Up to Week 40
Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
Time Frame: Up to Week 40
Up to Week 40
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Time Frame: Up to Week 40
Up to Week 40
Number of Participants With at Least One Treatment-Related Adverse Event
Time Frame: Up to Week 40
Up to Week 40
Number of Participants who Discontinued Treatment due to an Adverse Event
Time Frame: Up to Week 40
Up to Week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Time Frame: Week 40 to Week 80
Week 40 to Week 80

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Investigators

  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

April 26, 2028

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV53408-IMM-10209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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