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New shot aims to restore skin color in vitiligo patients

NCT ID NCT06625177

Disease control Sponsor: Teva Branded Pharmaceutical Products R&D LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called TEV-53408 in 38 adults with vitiligo. The main goal is to see if the drug is safe when given as a shot under the skin. Researchers will also look for early signs that it might help bring back skin color. The study lasts 84 weeks, including treatment, a washout period, and follow-up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TEV-53408 injection
What this could lead to
If it works, this could point toward a new treatment option to help restore skin color in people with vitiligo.
What could go wrong
This is a very early, small Phase 1b trial focused on safety, not proof of effectiveness. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

vitiligo

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vitiligo

Contacts and locations

Locations

  • Teva Investigational Site 12043

    Scottsdale, Arizona, 85260, United States

  • Teva Investigational Site 12044

    Fremont, California, 94538, United States

  • Teva Investigational Site 12045

    Dallas, Texas, 75230, United States

  • Teva Investigational Site 12046

    Pasadena, California, 91101, United States

  • Teva Investigational Site 12047

    Chicago, Illinois, 60614, United States

  • Teva Investigational Site 12048

    Canton, Michigan, 48187, United States

  • Teva Investigational Site 12049

    Miramar, Florida, 33025, United States

  • Teva Investigational Site 12051

    Irvine, California, 92617, United States

  • Teva Investigational Site 12052

    Hot Springs, Arkansas, 71913, United States

  • Teva Investigational Site 12053

    Louisville, Kentucky, 40421, United States

  • Teva Investigational Site 12054

    Portland, Oregon, 97210, United States

  • Teva Investigational Site 12055

    South Jordan, Utah, 84095, United States

  • Teva Investigational Site 12057

    Webster, Texas, 77598, United States

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