A Phase 2/3 interventional study of TEV-53408 Dose A and TEV-53408 Dose B in Vitiligo, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Teva Branded Pharmaceutical Products R&D LLC (part of Teva Pharmaceutical Industries, Ltd.) · Phase 2/3, Interventional, and Treatment
The goal of these clinical trials is to learn if TEV-53408 can help adults with Non-Segmental Vitiligo (NSV). Vitiligo causes patches of skin to lose their color.
The main questions the trials aim to answer are:
Can TEV-53408 help bring color back to the skin on the face? Can TEV-53408 help bring color back to the skin on the body? What side effects may happen with TEV-53408?
TEV-53408 will be compared with placebo to see if it helps bring color back to the skin.
Participants will:
Receive TEV-53408 or placebo as an injection under the skin Have their skin checked during the trials Answer questions about how vitiligo affects their daily life Have blood tests and other health checks
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 1,020 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NOTE- Additional criteria may apply at screening for clinical trial participation.
Exclusion Criteria:
NOTE- Additional criteria may apply at screening for clinical trial participation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: TEV-53408 Dose A
Drug: TEV-53408 Dose B
Drug: Placebo
Injectable- Subcutaneous administration.
Injectable- Subcutaneous administration.
Injectable- Subcutaneous administration.
Trial 1: Proportion of Participants Achieving a ≥75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI75)
The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas.
Time frame: Baseline, Week 24
Trial 2: Proportion of Participants Achieving F-VASI75
Time frame: Baseline, Week 48
Trial 2: Proportion of Participants Achieving T-VASI50 (US Only)
T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body.
Time frame: Baseline, Week 48
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Facial Vitiligo Area Scoring Index (F-VASI50)
Time frame: Baseline, Week 24
Trial 1: Proportion of Participants Achieving F-VASI75
Time frame: Baseline, Week 48
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Total Vitiligo Area Scoring Index (T-VASI50)
Time frame: Baseline, Week 24
Trial 1: Proportion of Participants Achieving T-VASI50
Time frame: Baseline, Week 48
Trial 1: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)
Time frame: Baseline, Week 24
Trial 1: Percent Change in F-VASI
Time frame: Baseline, Week 48
Trial 1: Percent Change in Total Vitiligo Area Scoring Index (T-VASI)
Time frame: Baseline, Week 48
Trial 1: Proportion of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)"
Time frame: Baseline, Week 48
Trial 1: Proportion of Participants Achieving (1) "Very much improved" or (2) "Much improved" on Patient Global Impression of Change -Vitiligo (PaGIC-V)
Time frame: Baseline, Week 48
Trial 1: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Week 88
Trial 1: Incidence of Serious Adverse Events (SAEs)
Time frame: Week 88
Trial 1: Incidence of Adverse Events (AEs) Leading to Discontinuation
Time frame: Week 88
Trial 1: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)
Time frame: Week 88
Trial 2: Proportion of Participants Achieving T-VASI50 (non-US only)
Time frame: Baseline, Week 48
Trial 2: Proportion of Participants Achieving F-VASI75
Time frame: Baseline, Week 24
Trial 2: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)
Time frame: Baseline, Week 24
Trial 2: Proportion of Participants Achieving F-VASI50
Time frame: Baseline, Week 48
Trial 2: Percent Change in F-VASI
Time frame: Baseline, Week 48
Trial 2: Percent Change in T-VASI
Time frame: Baseline, Week 48
Trial 2: Proportion of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)"
Time frame: Baseline, Week 48
Trial 2: Proportion of Participants Achieving (1) "Very much improved" or (2) "Much improved" on PaGIC-V
Time frame: Baseline, Week 48
Trial 2: Proportion of Participants Achieving a ≥90% Reduction in Facial Vitiligo Area Scoring Index (F-VASI90)
Time frame: Baseline, Week 48
Trial 2: Proportion of Participants Achieving a ≥75% Reduction in Total Vitiligo Area Scoring Index (T-VASI75)
Time frame: Baseline, Week 48
Trial 2: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Week 88
Trial 2: Incidence of Serious Adverse Events (SAEs)
Time frame: Week 88
Trial 2: Incidence of Adverse Events (AEs) Leading to Discontinuation
Time frame: Week 88
Trial 2: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)
Time frame: Week 88
No study locations are listed for this record.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2030, 45 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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