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Not recruiting
Phase 1

TEV-53408

Sponsor:

Teva Branded Pharmaceutical Products R&D LLC

Code:

NCT06625177

Conditions

Vitiligo

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TEV-53408

Study Details

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

Study ID

NCT06625177

Start date

Nov 11, 2024

Status verified date

Dec, 2025

Completion date

Jun 5, 2027

Anticipated

Primary completion date

May 9, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TEV-53408

solution administered subcutaneously

Interventions

TEV-53408

TEV-53408 injection administered subcutaneously

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Teva U.S. Medical Information

1-888-483-8279USMedInfo@tevapharm.com

Locations

Teva Investigational Site 12051

Recruiting

Irvine, California, United States, 92617

More Information

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D LLC on 2025-12-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.