VitiligoPhase 2/3NCT07920211
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
A Phase 2/3 study testing TEV-53408 Dose A and TEV-53408 Dose B in people with Vitiligo, run by Teva Branded Pharmaceutical Products R&D LLC.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- TEV-53408 Dose A and TEV-53408 Dose B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,020 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2026to 19 Jun 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant must have a diagnosis of Non-Segmental Vitiligo (NSV) for at least 3 months prior to screening. Participants of all skin types, as assessed by the Fitzpatrick scale, may be included.
- Stable or active NSV for at least 3 months prior to screening and the VASI scores: The participant has an F-VASI score ≥0.5 and a T-VASI score ≥5 and ≤60.
- A female participant is not pregnant or breastfeeding and agrees to refrain from donating oocytes throughout the duration of the trial.
- A male participant agrees to Refrain from donating sperm, EITHER abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR agrees to use a male condom with female partner.
- NOTE- Additional criteria may apply at screening for clinical trial participation.
Who cannot join
- The participant has autoimmune diseases for which systemic immunotherapy is or may be warranted including, but not limited to, rheumatoid arthritis, inflammatory bowel disease (Crohn's disease/ulcerative colitis), systemic lupus erythematosus, psoriasis, psoriatic arthritis, or multiple sclerosis. Conditions such as type 1 diabetes, stable hypothyroidism (Hashimoto's disease), and alopecia are not exclusionary.
- The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma.
- The participant has a body mass index outside the range of 18.5 to 40.0 kg/m2 (inclusive).
- The participant has an active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening.
- The participant has a known genetic or acquired immune deficiency.
- The participant has a history of disseminated herpes simplex, multidermatomal, ophthalmic or recurrent herpes zoster, or herpes encephalitis.
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- The participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas. If necessary, the sponsor can be contacted for assessment of eligibility regarding history of prior vitiligo therapy and/or prior clinical trial experience.
- The participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
- The participant has a history of chronic alcohol or substance abuse disorder within the previous 2 years.
- NOTE- Additional criteria may apply at screening for clinical trial participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Program Consisting of a Phase 2b Trial and a Phase 3 Trial to Evaluate the Efficacy and Safety of TEV-53408 in Participants With Non-Segmental Vitiligo
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
- Conditions
- Vitiligo
- Being tested
- TEV-53408 Dose A, TEV-53408 Dose B, Placebo
- Keywords
- Non-Segmental Vitiligo (NSV), VIVID
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-53408 Dose ADrug
Injectable- Subcutaneous administration.
TEV-53408 Dose BDrug
Injectable- Subcutaneous administration.
PlaceboDrug
Injectable- Subcutaneous administration.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: TEV-53408 | Experimental | Not described Receives: Drug: TEV-53408 Dose A |
| Group 2: TEV-53408 | Experimental | Not described Receives: Drug: TEV-53408 Dose B |
| Group 3: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Trial 2: Proportion of Participants Achieving F-VASI75
Measured: 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.
Measured: Baseline, Week 48
Secondary outcomes (27)
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Facial Vitiligo Area Scoring Index (F-VASI50)
Measured: Baseline, Week 24
Trial 1: Proportion of Participants Achieving F-VASI75
Measured: Baseline, Week 48
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Total Vitiligo Area Scoring Index (T-VASI50)
Measured: Baseline, Week 24
Trial 1: Proportion of Participants Achieving T-VASI50
Measured: Baseline, Week 48
Trial 1: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)
Measured: Baseline, Week 24
Trial 1: Percent Change in F-VASI
Measured: Baseline, Week 48
Trial 1: Percent Change in Total Vitiligo Area Scoring Index (T-VASI)
Measured: 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)"
Measured: 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)
Measured: Baseline, Week 48
Trial 1: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Week 88
Trial 1: Incidence of Serious Adverse Events (SAEs)
Measured: Week 88
Trial 1: Incidence of Adverse Events (AEs) Leading to Discontinuation
Measured: Week 88
Trial 1: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)
Measured: Week 88
Trial 2: Proportion of Participants Achieving T-VASI50 (non-US only)
Measured: Baseline, Week 48
Trial 2: Proportion of Participants Achieving F-VASI75
Measured: Baseline, Week 24
Trial 2: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)
Measured: Baseline, Week 24
Trial 2: Proportion of Participants Achieving F-VASI50
Measured: Baseline, Week 48
Trial 2: Percent Change in F-VASI
Measured: Baseline, Week 48
Trial 2: Percent Change in T-VASI
Measured: 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)"
Measured: Baseline, Week 48
Trial 2: Proportion of Participants Achieving (1) "Very much improved" or (2) "Much improved" on PaGIC-V
Measured: Baseline, Week 48
Trial 2: Proportion of Participants Achieving a ≥90% Reduction in Facial Vitiligo Area Scoring Index (F-VASI90)
Measured: Baseline, Week 48
Trial 2: Proportion of Participants Achieving a ≥75% Reduction in Total Vitiligo Area Scoring Index (T-VASI75)
Measured: Baseline, Week 48
Trial 2: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Week 88
Trial 2: Incidence of Serious Adverse Events (SAEs)
Measured: Week 88
Trial 2: Incidence of Adverse Events (AEs) Leading to Discontinuation
Measured: Week 88
Trial 2: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)
Measured: Week 88
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start16 Nov 2026 (estimated)
- Primary completion12 Sep 2030 (estimated)
- Study completion19 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Teva Branded Pharmaceutical Products R&D LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920211
- Sponsor's protocol ID
- TV53408-IMM-30105
- Other IDs
- 2026-527760-32-00
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Program Consisting of a Phase 2b Trial and a Phase 3 Trial to Evaluate the Efficacy and Safety of TEV-53408 in Participants With Non-Segmental Vitiligo
- ClinicalTrials.gov ID
- NCT07920211
- Acronym / sponsor ID
- TV53408-IMM-30105
- Conditions
- Vitiligo
- Keywords
- Non-Segmental Vitiligo (NSV), VIVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 12 Sep 2030 (estimated)
- Study completion
- 19 Jun 2031 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: TEV-53408 | Experimental | Drug: TEV-53408 Dose A |
| Group 2: TEV-53408 | Experimental | Drug: TEV-53408 Dose B |
| Group 3: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participant must have a diagnosis of Non-Segmental Vitiligo (NSV) for at least 3 months prior to screening. Participants of all skin types, as assessed by the Fitzpatrick scale, may be included.
- Stable or active NSV for at least 3 months prior to screening and the VASI scores: The participant has an F-VASI score ≥0.5 and a T-VASI score ≥5 and ≤60.
- A female participant is not pregnant or breastfeeding and agrees to refrain from donating oocytes throughout the duration of the trial.
- A male participant agrees to Refrain from donating sperm, EITHER abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR agrees to use a male condom with female partner.
- NOTE- Additional criteria may apply at screening for clinical trial participation.
Key exclusion criteria (10 listed)
- The participant has autoimmune diseases for which systemic immunotherapy is or may be warranted including, but not limited to, rheumatoid arthritis, inflammatory bowel disease (Crohn's disease/ulcerative colitis), systemic lupus erythematosus, psoriasis, psoriatic arthritis, or multiple sclerosis. Conditions such as type 1 diabetes, stable hypothyroidism (Hashimoto's disease), and alopecia are not exclusionary.
- The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma.
- The participant has a body mass index outside the range of 18.5 to 40.0 kg/m2 (inclusive).
- The participant has an active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening.
- The participant has a known genetic or acquired immune deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEV-53408 Dose AInjectable- Subcutaneous administration. | Drug | Group 1: TEV-53408 |
| TEV-53408 Dose BInjectable- Subcutaneous administration. | Drug | Group 2: TEV-53408 |
| PlaceboInjectable- Subcutaneous administration. | Drug | Group 3: Placebo |
Primary outcome
Trial 1: Proportion of Participants Achieving a ≥75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI75)
Time frame: Baseline, Week 24
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.
Trial 2: Proportion of Participants Achieving F-VASI75
Time frame: Baseline, Week 48
Trial 2: Proportion of Participants Achieving T-VASI50 (US Only)
Time frame: Baseline, Week 48
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.
27 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TEV-53408 Dose A and TEV-53408 Dose B in people with Vitiligo, run by Teva Branded Pharmaceutical Products R&D LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teva U.S. Medical Information (1-888-483-8279, USMedInfo@tevapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial 1: Proportion of Participants Achieving a ≥75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI75) (time frame: Baseline, Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.