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

Phase 1

Recruiting

• Conditions: Vitiligo
• Interventions: Drug: TEV-53408

• Registration Number: NCT06625177
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Study Start: 2024-11-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-05-09
• Study Completion: 2027-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TEV-53408	TEV-53408	solution administered subcutaneously

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest	Week 40 to Week 80

Trial Locations

Locations (11)

Teva Investigational Site 12054; 🇺🇸 Portland, Oregon, United States

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 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 12045; 🇺🇸 Dallas, Texas, United States

Teva Investigational Site 12055; 🇺🇸 South Jordan, Utah, United States