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

30. oktober 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1020

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Gruppe 3: Placebo
Legemiddel: Placebo

Injectable- Subcutaneous administration.
Eksperimentell: Group 1: TEV-53408
Legemiddel: TEV-53408 Dose A

Injectable- Subcutaneous administration.
Eksperimentell: Group 2: TEV-53408
Legemiddel: TEV-53408 Dose B

Injectable- Subcutaneous administration.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Trial 1: Proportion of Participants Achieving a ≥75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI75)
Tidsramme: 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
Tidsramme: Baseline, Week 48
Baseline, Week 48
Trial 2: Proportion of Participants Achieving T-VASI50 (US Only)
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

16. november 2026

Primær fullføring (Antatt)

12. september 2030

Studiet fullført (Antatt)

19. juni 2031

Datoer for studieregistrering

Først innsendt

30. oktober 2026

Først innsendt som oppfylte QC-kriteriene

30. oktober 2026

Først lagt ut (Faktiske)

5. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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