ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1b, Open-Label Trial to Assess Safety and Exploratory Efficacy of TEV-53408 in Participants With Vitiligo

Quick Facts

Study Start:2024-11-11

Study Completion:2027-06-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06625177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Teva Medical Expert, MD

STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D LLC

Study Locations (Sites)

Teva Investigational Site 12043

Scottsdale, Arizona, 85260

United States

Teva Investigational Site 12052

Hot Springs, Arkansas, 71913

United States

Teva Investigational Site 12044

Fremont, California, 94538

United States

Teva Investigational Site 12051

Irvine, California, 92617

United States

Teva Investigational Site 12046

Pasadena, California, 91101

United States

Teva Investigational Site 12049

Miramar, Florida, 33025

United States

Teva Investigational Site 12047

Chicago, Illinois, 60614

United States

Teva Investigational Site 12053

Louisville, Kentucky, 40421

United States

Teva Investigational Site 12048

Canton, Michigan, 48187

United States

Teva Investigational Site 12054

Portland, Oregon, 97210

United States

Teva Investigational Site 12045

Dallas, Texas, 75230

United States

Teva Investigational Site 12057

Webster, Texas, 77598

United States

Teva Investigational Site 12055

South Jordan, Utah, 84095

United States

Collaborators and Investigators

Sponsor: Teva Branded Pharmaceutical Products R&D LLC

Teva Medical Expert, MD, STUDY_DIRECTOR, Teva Branded Pharmaceutical Products R&D LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11

Study Completion Date2027-06-05

Study Record Updates

Study Start Date2024-11-11

Study Completion Date2027-06-05

Terms related to this study

Additional Relevant MeSH Terms

Vitiligo