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Une étude pour évaluer l'innocuité et l'efficacité à long terme du rozanolixizumab chez les participants adultes atteints de myasthénie oculaire (MyVisionXT)

5 novembre 2026 mis à jour par: UCB Biopharma SRL

Une étude de phase 3, en ouvert, d'extension pour évaluer la sécurité et l'efficacité à long terme du Rozanolixizumab chez les participants adultes atteints de myasthénie oculaire

The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • 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

Sauvegarde des contacts de l'étude

  • Nom: UCB Cares
  • Numéro de téléphone: 00184459922733 (UCB)
  • E-mail: ucbcares@ucb.com

Lieux d'étude

  • Chine
      • Beijing, Chine
        • Recrutement
        • Mg0039 31901
      • Beijing, Chine
        • Recrutement
        • Mg0039 31912
      • Chongqing, Chine
        • Recrutement
        • Mg0039 31908
      • Nanchang, Chine
        • Recrutement
        • Mg0039 31907
      • Suzhou, Chine
        • Recrutement
        • Mg0039 31902
  • Espagne
      • Barcelona, Espagne
        • Recrutement
        • Mg0039 20604
      • Madrid, Espagne
        • Recrutement
        • Mg0039 20611
      • Murcia, Espagne
        • Recrutement
        • Mg0039 20602
      • Málaga, Espagne
        • Recrutement
        • Mg0039 20606
  • France
      • Nice, France
        • Recrutement
        • Mg0039 20301
  • Géorgie
      • Sarajishvili, Géorgie
        • Recrutement
        • Mg0039 21403
      • Tbilisi, Géorgie
        • Recrutement
        • Mg0039 21402
  • Japon
      • Kobe, Japon
        • Recrutement
        • Mg0039 31802
      • Minatoku, Japon
        • Recrutement
        • Mg0039 31804
      • Sendai, Japon
        • Recrutement
        • Mg0039 31805
  • Pologne
      • Lublin, Pologne
        • Recrutement
        • Mg0039 21206
  • États-Unis
    • Arizona
      • Scottsdale, Arizona, États-Unis, 85251
        • Recrutement
        • Mg0039 10104
    • Ohio
      • Columbus, Ohio, États-Unis, 43210
        • Recrutement
        • Mg0039 10103

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:

  • Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)

  • Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG0038

  • Participant for whom the investigator considers a favorable benefit/risk for participation

  • Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator

  • Male or female

  • A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies:

    • Not a woman of childbearing potential (WOCBP) OR
    • A WOCBP who agrees to follow the contraceptive guidance for the entire study period

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol

Exclusion Criteria:

  • Participant meets any of the withdrawal criteria defined in MG0038
  • Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry.
  • Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab
  • Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies
  • Participant has planned use of prohibited medications

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: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Rozanolixizumab

The study is composed of Extended Observation Period(s) and Symptom-driven Cycle(s). Based on their clinical need for treatment, study participants will be able to start the study with either an Extended Observation Period or a Symptom-driven Cycle.

A Symptom-driven Cycle will be initiated based on disease worsening and participants will receive rozanolixizumab based on investigator's medical judgement.
Médicament: Rozanolixizumab

Rozanolixizumab will be administered by subcutaneous infusion.

Autres noms:
  • UCB7665

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of treatment-emergent adverse events (TEAEs)
Délai: Up to 2 years

Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.
Up to 2 years
Incidence of treatment-emergent serious adverse events (TESAEs)
Délai: Up to 2 years

An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Up to 2 years
Incidence of TEAEs leading to permanent withdrawal of study treatment
Délai: Up to 2 years

Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. This measure considers any TEAE leading to permanent withdrawal from study.
Up to 2 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome part)
Délai: At Day 43 (of the first 3 Symptom-driven Cycles)

MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week".
At Day 43 (of the first 3 Symptom-driven Cycles)
Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular score
Délai: At Day 43 (of the first 3 Symptom-driven Cycles)

The MG-ADL score is an 8-item patient-reported outcome (PRO) instrument. The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability. The two ocular items will be summed for the ocular score, ranging from 0 to 6.
At Day 43 (of the first 3 Symptom-driven Cycles)
Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score
Délai: At Day 43 (of the first 3 Symptom-driven Cycles)

The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Only the ocular muscle weakness scale will be used in this study. Ocular symptom severity is assessed over the past 7 days using a 4-point verbal rating scale (none, mild, moderate, severe)
At Day 43 (of the first 3 Symptom-driven Cycles)
Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score
Délai: At Day 43 (of the first 3 Symptom-driven Cycles)

The MG-QoL15r is a 15-item PRO measure that is designed to assess aspects of health-related quality of life related to MG. The recall period that will be used is "past 7 days". Each item has 3 response options (0-2) and the total score ranges from 0 to 30, with higher scores indicating more severe impact on health-related QoL (HRQOL).
At Day 43 (of the first 3 Symptom-driven Cycles)
Study participant who generalizes to Myasthenia Gravis Foundation of America (MGFA) class ≥2 over time
Délai: Up to 2 years

MGFA Clinical Classification is a 5-stage classification (I to V), with a higher class indicating more severe disease.
Up to 2 years
Change from Baseline in MGII total and generalized score over time
Délai: Up to 2 years

MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week".
Up to 2 years
Change from Baseline in MG-ADL total score over time
Délai: Up to 2 years

The MG-ADL score is an 8-item patient-reported outcome (PRO) instrument. The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability. The two ocular items will be summed for the ocular score, ranging from 0 to 6.
Up to 2 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

UCB Biopharma SRL

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 (Réel)

16 septembre 2026

Achèvement primaire (Estimé)

17 mars 2031

Achèvement de l'étude (Estimé)

17 mars 2031

Dates d'inscription aux études

Première soumission

6 mars 2026

Première soumission répondant aux critères de contrôle qualité

6 mars 2026

Première publication (Réel)

11 mars 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MG0039
  • 2025-524757-14-00 (Ctis)
  • U1111-1334-3218 (Autre identifiant: Universal Trial Number)
  • CTR20262521 (Identificateur de registre: ChinaDrugTrials.org.cn)
  • 2025 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Délai de partage IPD

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

Critères d'accès au partage IPD

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

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 .

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