Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo

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

Study Overview

• Status: Not yet recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Drug: TEV-53408 Dose A; Drug: TEV-53408 Dose B; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1020
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Teva U.S. Medical Information; Phone Number: 1-888-483-8279; Email: USMedInfo@tevapharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 3: Placebo	Drug: Placebo; Injectable- Subcutaneous administration.
Experimental: Group 1: TEV-53408	Drug: TEV-53408 Dose A; Injectable- Subcutaneous administration.
Experimental: Group 2: TEV-53408	Drug: TEV-53408 Dose B; Injectable- Subcutaneous administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 24
Trial 2: Proportion of Participants Achieving F-VASI75		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.	Baseline, Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Facial Vitiligo Area Scoring Index (F-VASI50)	Baseline, Week 24
Trial 1: Proportion of Participants Achieving F-VASI75	Baseline, Week 48
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Total Vitiligo Area Scoring Index (T-VASI50)	Baseline, Week 24
Trial 1: Proportion of Participants Achieving T-VASI50	Baseline, Week 48
Trial 1: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)	Baseline, Week 24
Trial 1: Percent Change in F-VASI	Baseline, Week 48
Trial 1: Percent Change in Total Vitiligo Area Scoring Index (T-VASI)	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)"	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)	Baseline, Week 48
Trial 1: Incidence of Treatment-Emergent Adverse Events (TEAEs)	Week 88
Trial 1: Incidence of Serious Adverse Events (SAEs)	Week 88
Trial 1: Incidence of Adverse Events (AEs) Leading to Discontinuation	Week 88
Trial 1: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)	Week 88
Trial 2: Proportion of Participants Achieving T-VASI50 (non-US only)	Baseline, Week 48
Trial 2: Proportion of Participants Achieving F-VASI75	Baseline, Week 24
Trial 2: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)	Baseline, Week 24
Trial 2: Proportion of Participants Achieving F-VASI50	Baseline, Week 48
Trial 2: Percent Change in F-VASI	Baseline, Week 48
Trial 2: Percent Change in T-VASI	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)"	Baseline, Week 48
Trial 2: Proportion of Participants Achieving (1) "Very much improved" or (2) "Much improved" on PaGIC-V	Baseline, Week 48
Trial 2: Proportion of Participants Achieving a ≥90% Reduction in Facial Vitiligo Area Scoring Index (F-VASI90)	Baseline, Week 48
Trial 2: Proportion of Participants Achieving a ≥75% Reduction in Total Vitiligo Area Scoring Index (T-VASI75)	Baseline, Week 48
Trial 2: Incidence of Treatment-Emergent Adverse Events (TEAEs)	Week 88
Trial 2: Incidence of Serious Adverse Events (SAEs)	Week 88
Trial 2: Incidence of Adverse Events (AEs) Leading to Discontinuation	Week 88
Trial 2: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)	Week 88

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D LLC
• Investigators: Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC

Study record dates

Study Major Dates

• Study Start (Estimated): November 16, 2026
• Primary Completion (Estimated): September 12, 2030
• Study Completion (Estimated): June 19, 2031

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: October 30, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Non-Segmental Vitiligo (NSV), VIVID
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo
• Other Study ID Numbers: TV53408-IMM-30105; 2026-527760-32-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No