Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
30 octobre 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
1020
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Teva U.S. Medical Information
- Numéro de téléphone: 1-888-483-8279
- E-mail: USMedInfo@tevapharm.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Groupe 3 : Placebo
|
Injectable- Subcutaneous administration. |
|
Expérimental: Group 1: TEV-53408
|
Injectable- Subcutaneous administration. |
|
Expérimental: Group 2: TEV-53408
|
Injectable- Subcutaneous administration. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Trial 1: Proportion of Participants Achieving a ≥75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI75)
Délai: 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
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
|
Trial 2: Proportion of Participants Achieving T-VASI50 (US Only)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Facial Vitiligo Area Scoring Index (F-VASI50)
Délai: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 1: Proportion of Participants Achieving F-VASI75
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Total Vitiligo Area Scoring Index (T-VASI50)
Délai: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 1: Proportion of Participants Achieving T-VASI50
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)
Délai: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 1: Percent Change in F-VASI
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Percent Change in Total Vitiligo Area Scoring Index (T-VASI)
Délai: 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)"
Délai: 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)
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Délai: Week 88
|
Week 88
|
|
Trial 1: Incidence of Serious Adverse Events (SAEs)
Délai: Week 88
|
Week 88
|
|
Trial 1: Incidence of Adverse Events (AEs) Leading to Discontinuation
Délai: Week 88
|
Week 88
|
|
Trial 1: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)
Délai: Week 88
|
Week 88
|
|
Trial 2: Proportion of Participants Achieving T-VASI50 (non-US only)
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving F-VASI75
Délai: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 2: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)
Délai: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 2: Proportion of Participants Achieving F-VASI50
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Percent Change in F-VASI
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Percent Change in T-VASI
Délai: 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)"
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving (1) "Very much improved" or (2) "Much improved" on PaGIC-V
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving a ≥90% Reduction in Facial Vitiligo Area Scoring Index (F-VASI90)
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving a ≥75% Reduction in Total Vitiligo Area Scoring Index (T-VASI75)
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Délai: Week 88
|
Week 88
|
|
Trial 2: Incidence of Serious Adverse Events (SAEs)
Délai: Week 88
|
Week 88
|
|
Trial 2: Incidence of Adverse Events (AEs) Leading to Discontinuation
Délai: Week 88
|
Week 88
|
|
Trial 2: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)
Délai: Week 88
|
Week 88
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
16 novembre 2026
Achèvement primaire (Estimé)
12 septembre 2030
Achèvement de l'étude (Estimé)
19 juin 2031
Dates d'inscription aux études
Première soumission
30 octobre 2026
Première soumission répondant aux critères de contrôle qualité
30 octobre 2026
Première publication (Réel)
5 novembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 octobre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TV53408-IMM-30105
- 2026-527760-32-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .