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TEV-53408 for Vitiligo

Phase 1
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* The participant has a diagnosis of active or stable vitiligo for at least 3 months.
* The participant agrees to discontinue all agents and procedures used to treat vitiligo during the treatment period in the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of TEV-53408 for treating vitiligo in adults. The study will last 84 weeks for each participant and will include different treatment and observation

Who is the study for?
This trial is for adults with vitiligo, a skin condition causing loss of pigment. Participants must have had vitiligo for at least 3 months, have a BMI between 18.5 and 40.0 kg/m2, agree to use effective contraception if necessary, not be pregnant or breastfeeding, and avoid sun exposure during the trial.
What is being tested?
The study tests TEV-53408's safety and effectiveness in treating vitiligo over an 84-week period involving treatment, washout, and follow-up phases. The drug is given as a subcutaneous injection.
What are the potential side effects?
While specific side effects are not listed here, the study aims to evaluate any potential adverse reactions from using TEV-53408 throughout its different phases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with vitiligo for at least 3 months.
Select...
I agree to stop all my current vitiligo treatments during the trial.
Select...
I agree to avoid long sun exposure, use sunscreen, and not use tanning devices.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TEV-53408Experimental Treatment1 Intervention
solution administered subcutaneously

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
256 Previous Clinical Trials
3,486,440 Total Patients Enrolled
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
97 Previous Clinical Trials
39,653 Total Patients Enrolled
~16 spots leftby May 2026
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