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

30 oktober 2026 bijgewerkt door: Teva Branded Pharmaceutical Products R&D LLC

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

1020

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Groep 3: Placebo
Geneesmiddel: Placebo

Injectable- Subcutaneous administration.
Experimenteel: Group 1: TEV-53408
Geneesmiddel: TEV-53408 Dose A

Injectable- Subcutaneous administration.
Experimenteel: Group 2: TEV-53408
Geneesmiddel: TEV-53408 Dose B

Injectable- Subcutaneous administration.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Trial 1: Proportion of Participants Achieving a ≥75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI75)
Tijdsspanne: 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.
Baseline, Week 24
Trial 2: Proportion of Participants Achieving F-VASI75
Tijdsspanne: Baseline, Week 48
Baseline, Week 48
Trial 2: Proportion of Participants Achieving T-VASI50 (US Only)
Tijdsspanne: 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.
Baseline, Week 48

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Onderzoekers

  • Studie directeur: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

16 november 2026

Primaire voltooiing (Geschat)

12 september 2030

Studie voltooiing (Geschat)

19 juni 2031

Studieregistratiedata

Eerst ingediend

30 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 oktober 2026

Eerst geplaatst (Werkelijk)

5 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TV53408-IMM-30105
  • 2026-527760-32-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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