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โ† Trials
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A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo

RecruitingPhase 1Ages 18 Years - 75 YearsAllTeva Branded Pharmaceutical Products R&D LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • TEV-53408
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Where

13 sites
Teva Investigational Site 12043
Scottsdale, United States
Teva Investigational Site 12052
Hot Springs, United States
Teva Investigational Site 12044
Fremont, United States
Teva Investigational Site 12051
Irvine, United States
Teva Investigational Site 12046
Pasadena, United States
Teva Investigational Site 12049
Miramar, United States
Teva Investigational Site 12047
Chicago, United States
Teva Investigational Site 12053
Louisville, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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