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

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 awoman of nonchildbearing potential OR is a women of childbearing potential using acontraceptive method that is highly effective AND agrees not to donate eggs for thepurpose of reproduction for the required period

• A male participant is eligible if he agrees to refrain from donating sperm PLUSremain abstinent from heterosexual intercourse OR use a male condom with a femalepartner for the required period

• The participant is capable of giving signed, informed consent

• The participant agrees to discontinue all agents and procedures used to treatvitiligo 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 usesunscreen, and must not use tanning booths, sun lamps, or other ultraviolet lightsources

NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• The participant suffers from vitiligo induced by exposure to chemicals orimmunotherapy known to induce vitiligo

• The participant has other autoimmune diseases for which systemic immunotherapy is ormay be warranted

• The participant has current or history of malignancy or treatment of malignancy inthe last 5 years, excluding fully-treated basal cell carcinoma

• Infectious disease

• The participant has used skin bleaching treatments for past treatment of vitiligo orother pigmented areas

• The participant has a history of melanocyte-keratinocyte transplantation procedureor other surgical treatment for vitiligo. After 2 or more years since lastmelanocyte-keratinocyte transplantation procedure, the participants may be includedin the trial.

• The participant has donated or received any blood or blood products (white bloodcells, platelets, etc) within the 60 days prior to screening or has donated blood orblood products on 2 or more occasions within the 6 months prior to IMPadministration, or has donated plasma within 7 days before the screening visit, orhas 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