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A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)

28 août 2026 mis à jour par: Dianthus Therapeutics

A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)

The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

The study includes the following periods:

  • Screening (up to 12 weeks)
  • Randomized, blinded, controlled treatment (RCT) period (17 weeks)
  • Extended treatment period (ETP) (104 weeks) (optional) for eligible participants [includes blinded extension period (BEP) and open-label extension (OLE) period]
  • Safety Follow-Up period (40 weeks)

Type d'étude

Interventionnel

Inscription (Estimé)

195

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

Lieux d'étude

  • États-Unis
    • Florida
      • Boca Raton, Florida, États-Unis, 33432
        • Recrutement
        • Cinical Study Site
    • North Carolina
      • Fayetteville, North Carolina, États-Unis, 28304
        • Pas encore de recrutement
        • Cinical Study Site
    • Texas
      • Houston, Texas, États-Unis, 77009
        • Recrutement
        • Cinical Study Site

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Must have given written informed consent before any study-related activities are carried out
  2. Weight range between 40-130 kg at Screening

  3. Diagnosis of gMG by the following tests:

    1. Acetylcholine receptor antibody (AChR Ab) positive, and
    2. One of the following:

    i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.

  4. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa
  5. MG-ADL scale score of 6 or more
  6. QMG scale score of 10 or more
  7. Documented vaccinations against encapsulated bacteria in accordance with local requirements and based on vaccine availability
  8. Female participants must be of non-childbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception
  9. Male participants agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception

Exclusion Criteria:

  1. History or presence of significant medical/surgical condition including any acute illness, mental illness, or major surgery considered to be clinically significant or that could have potential impact on safety/efficacy or study procedures
  2. Known complement deficiency
  3. Prior history (at any time) of N. meningitidis infection
  4. Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBV; except participants who are seropositive because of HBV vaccination) or hepatitis C virus (HCV) during Screening
  5. Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. [
  6. Any thymic surgery/biopsy within 1 year of Screening
  7. Any known or untreated thymoma.
  8. Any history of thymic carcinoma or thymic malignancy
  9. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone

  10. Concurrent or previous use of the following medication within the time periods specified below.

    1. Rituximab or other B-cell targeting therapies (ie, inebilizumab) within 6 months (180 days) prior to randomization (Day 1);
    2. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1)
  11. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent
  12. Diagnosis of systemic lupus erythematosus (SLE) or family history (defined as a parent, sibling, or child) of SLE

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 parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Intravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8).
Médicament: Placebo
IV infusion on Day 1
Produit combiné: Placebo
Prefilled syringe containing placebo for SC administration
Expérimental: Claseprubart Q2W
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8).
Médicament: Claseprubart
IV loading dose on Day 1
Autres noms:
  • DNTH103
Produit combiné: Claseprubart
Prefilled syringe containing claseprubart for SC administration
Expérimental: Claseprubart Every 4 weeks (Q4W)
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo.
Produit combiné: Placebo
Prefilled syringe containing placebo for SC administration
Médicament: Claseprubart
IV loading dose on Day 1
Autres noms:
  • DNTH103
Produit combiné: Claseprubart
Prefilled syringe containing claseprubart for SC administration

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from Baseline to Week 17 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
Délai: Baseline (Day 1) to Week 17
The MG-ADL score is an 8-item patient reported outcome (PRO) instrument. The MG-ADL targets symptoms of disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of the MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
Baseline (Day 1) to Week 17

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) Scale Score
Délai: Baseline (Day 1) to Week 17
The QMG is a clinician-reported assessment to evaluate muscle strength. The QMG consists of 13 items that measure endurance or fatiguability, with each item having a possible score that ranges from 0 - 3. The total possible QMG scores range from 0 - 39, with a higher score indicating greater disease burden.
Baseline (Day 1) to Week 17
Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) Scale Score
Délai: Baseline (Day 1) to Week 17
The MGC is a validated assessment tool for measuring clinical status of participants with MG. The range of total MGC score is 0 to 50, with higher scores indicating more severe disease. A clinically meaningful improvement is reflected by a 3-point improvement in MGC score. The MGC assesses 10 important functional areas most frequently affected by MG and the scales are weighted for clinical significance that incorporates patient-reported outcomes.
Baseline (Day 1) to Week 17
Proportion of Participants with Greater Than or Equal to (≥) a 5-point Reduction in MG-ADL Scale Score at Week 17 Compared to Baseline
Délai: Baseline (Day 1) to Week 17
Baseline (Day 1) to Week 17
Proportion of Participants Who Reach Minimal Symptom Expression (MSE), Defined as MG-ADL 0 or 1 at Week 17, Without Use of Rescue Therapy
Délai: Baseline (Day 1) to Week 17
Baseline (Day 1) to Week 17
Proportion of Participants with a ≥ 5-point Reduction in QMG Scale Score at Week 17 Compared to Baseline
Délai: Baseline (Day 1) to Week 17
Baseline (Day 1) to Week 17
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-Emergent and Treatment-Emergent Serious Adverse Events (SAEs) in the RCT period, BEP, OLE, and Safety Follow-Up
Délai: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Serum Concentrations of Claseprubart
Délai: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Blood samples will be collected for measurement of serum concentrations of claseprubart at various timepoints both pre- and post-dose.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Change from Baseline in Complement Total Blood Test (CH50) in Serum ex vivo
Délai: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Blood samples will be collected to determine changes in CH50 at various timepoints.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Incidence of Antidrug Antibody (ADAs) Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
Délai: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Blood samples will be collected to measure ADA against claseprubart at various timepoints.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Titer of ADAs Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
Délai: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Blood samples will be collected to measure ADA against claseprubart at various timepoints.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)

Collaborateurs et enquêteurs

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

Parrainer

Dianthus Therapeutics

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)

29 juin 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2031

Dates d'inscription aux études

Première soumission

27 mai 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

15 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 août 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DNTH103-MG-301
  • 2026-525298-38-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

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

NON

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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