NCT06625177 · Teva Branded Pharmaceutical Products R&D LLC
A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo
What this study is about
The purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white.
View original scientific description
The purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white.
Interventions
DRUG
TEV-53408
TEV-53408 injection administered subcutaneously
Primary outcome measures
Number of Participants With at Least One Treatment-Emergent Adverse Event
Time frame: Up to Week 40
Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
Time frame: Up to Week 40
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Time frame: Up to Week 40
Number of Participants With at Least One Treatment-Related Adverse Event
Time frame: Up to Week 40
Number of Participants who Discontinued Treatment due to an Adverse Event
Time frame: Up to Week 40
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
- Hot Springs, Arkansas
- Fremont, California
- Irvine, California
- Pasadena, California
- Miramar, Florida
- Chicago, Illinois
- Louisville, Kentucky
- Canton, Michigan
- Portland, Oregon
- Dallas, Texas
- Webster, Texas
And 1 more location — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations