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Recruiting Phase 1

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

NCT06625177 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2024-11-11
Last updated
2026-10-29

Condition(s) studied

Vitiligo

Investigational drug(s) / intervention(s)

TEV-53408 →

TEV-53408: TEV-53408 injection administered subcutaneously

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (13)

FacilityCityRegionStatus
Scottsdale Clinical Research Scottsdale Arizona Terminated
Burke Pharmaceutical Research Hot Springs Arkansas Recruiting
Center for Dermatology Clinical Research, Inc. Fremont California Recruiting
University of CA Irvine Irvine California Active Not Recruiting
Pasadena Clinical Trials Pasadena California Active Not Recruiting
Watson Therapeutics Inc. (WTI), USA Miramar Florida Recruiting
MetroMed Clinical Trials Chicago Illinois Active Not Recruiting
DS Research of Kentucky Louisville Kentucky Recruiting
Hamzavi Dermatology Canton Michigan Recruiting
Oregon Dermatology and Research Center Portland Oregon Recruiting
Dermatology Treatment & Research Center Dallas Texas Recruiting
Center for Clinical Studies, LTD. LLP Webster Texas Active Not Recruiting
Jordan Valley Dermatology South Jordan Utah Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06625177 on ClinicalTrials.gov ↗ ← All trials in the USA