Testing TEV-53408 for treating vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the safety and efficacy of TEV-53408, administered subcutaneously, in adults diagnosed with vitiligo. Participants will undergo an 84-week study period, which includes a screening phase, a 24-week open-label treatment phase, a 16-week washout period, and a 40-week follow-up. The study will assess both the primary and secondary safety objectives of the treatment. Participants must discontinue any other vitiligo treatments during the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Burke Pharmaceutical Research
  Hot Springs, Arkansas, United States Recruiting
• Center for Dermatology Clinical Research, Inc.
  Fremont, California, United States Recruiting
• Watson Therapeutics Inc. (WTI), USA
  Miramar, Florida, United States Recruiting
• DS Research of Kentucky
  Louisville, Kentucky, United States Recruiting
• Hamzavi Dermatology
  Canton, Michigan, United States Recruiting
• Oregon Dermatology and Research Center
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Teva U.S. Medical Information
• Email: USMedInfo@tevapharm.com
• Phone: 1-888-483-8279

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• MH004 Ointment in non-segmental vitiligo: a phase 3 trial

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• NSV: Vitiligo Drug Safety and Effectiveness Registry for Adults and Teens

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• D-2570 in Non-Segmental Vitiligo (Phase 2)

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• LY4005130 for adults with non-segmental vitiligo

  This study will test whether intravenous LY4005130 is safe and what side effects it may cause in adults with non-segmental vitiligo.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.