A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo (NCT06625177) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo
United States38 participantsStarted 2024-11-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With at Least One Treatment-Emergent Adverse Event
Timeframe: Up to Week 40
2
Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
Timeframe: Up to Week 40
3
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Timeframe: Up to Week 40
4
Number of Participants With at Least One Treatment-Related Adverse Event
Timeframe: Up to Week 40
5
Number of Participants who Discontinued Treatment due to an Adverse Event