Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

30 oktober 2026 uppdaterad 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

1020

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Grupp 3: Placebo
Läkemedel: Placebo

Injectable- Subcutaneous administration.
Experimentell: Group 1: TEV-53408
Läkemedel: TEV-53408 Dose A

Injectable- Subcutaneous administration.
Experimentell: Group 2: TEV-53408
Läkemedel: TEV-53408 Dose B

Injectable- Subcutaneous administration.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

16 november 2026

Primärt slutförande (Beräknad)

12 september 2030

Avslutad studie (Beräknad)

19 juni 2031

Studieregistreringsdatum

Först inskickad

30 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

30 oktober 2026

Första postat (Faktisk)

5 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera