Vitiligo study: TEV-53408
Official title A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo
ClinicalTrials.gov ID: NCT06625177
What this study is testing
What is TEV-53408?
This is an investigational medicine being studied as a potential treatment for vitiligo.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to evaluate how safe TEV-53408 is when given as a subcutaneous injection to adults with vitiligo.
- Who it's for
- Adults who have vitiligo.
- What's involved
- Participants will receive injections under the skin of the drug TEV-53408.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- A male participant is eligible if he agrees to refrain from donating sperm PLUS remain abstinent from heterosexual intercourse OR use a male condom...
- The participant is capable of giving signed, informed consent
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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...
- The participant has current or history of alcohol or other substance abuse NOTE- Additional criteria apply, please contact the investigator for more information
The study team makes the final eligibility decision.
Where it is enrolling
- Hot Springs, Arkansas, United States
- Fremont, California, United States
- Miramar, Florida, United States
- Louisville, Kentucky, United States
- Canton, Michigan, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hot Springs, Arkansas, United States; Fremont, California, United States; Miramar, Florida, United States; Louisville, Kentucky, United States; Canton, Michigan, United States; Portland, Oregon, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.