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

NCT06625177 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: TV53408-IMM-10209
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 13

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest

  Week 40 to Week 80

Study Arms (1)

TEV-53408

EXPERIMENTAL

solution administered subcutaneously

Drug: TEV-53408

Interventions

TEV-53408 DRUG

TEV-53408 injection administered subcutaneously

TEV-53408

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (13)

Teva Investigational Site 12043

Scottsdale, Arizona, 85260, United States

Location

Teva Investigational Site 12052

Hot Springs, Arkansas, 71913, United States

Location

Teva Investigational Site 12044

Fremont, California, 94538, United States

Location

Teva Investigational Site 12051

Irvine, California, 92617, United States

Location

Teva Investigational Site 12046

Pasadena, California, 91101, United States

Location

Teva Investigational Site 12049

Miramar, Florida, 33025, United States

Location

Teva Investigational Site 12047

Chicago, Illinois, 60614, United States

Location

Teva Investigational Site 12053

Louisville, Kentucky, 40421, United States

Location

Teva Investigational Site 12048

Canton, Michigan, 48187, United States

Location

Teva Investigational Site 12054

Portland, Oregon, 97210, United States

Location

Teva Investigational Site 12045

Dallas, Texas, 75230, United States

Location

Teva Investigational Site 12057

Webster, Texas, 77598, United States

Location

Teva Investigational Site 12055

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): June 5, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (13)