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L'essai clinique NCT07155668 pour Maladie de l'Œil Thyroïdienne est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Viridian TherapeuticsA Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
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L'essai clinique NCT07155668 est conçu pour étudier le treatment de Maladie de l'Œil Thyroïdienne. Il s'agit d'un essai interventionnel en Phase III. Son statut actuel est : en recrutement. L'essai a débuté le 1 juillet 2025 et vise à recruter 75 participants. Dirigé par Viridian Therapeutics, l'essai devrait être terminé d'ici le 1 novembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 4 septembre 2025.
Résumé succinct
This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)
Description détaillée
This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.
Titre officiel
A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)
Conditions
Maladie de l'Œil ThyroïdienneAutres identifiants de l'essai
- VRDN-003-304
Numéro NCT
Date de début (réel)
2025-07-01
Dernière mise à jour publiée
2025-09-04
Date de fin (estimée)
2026-11
Inscription (estimée)
75
Type d'essai
Interventionnel
PHASE
Phase III
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalVRDN-003 every 4 weeks using autoinjector 6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\] | VRDN-003 VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). Autoinjector The autoinjector is a single-dose, disposable, ready-to-use delivery device |
ExpérimentalVRDN-003 every 8 weeks using autoinjector 3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\] | VRDN-003 VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). Autoinjector The autoinjector is a single-dose, disposable, ready-to-use delivery device |
ExpérimentalVRDN-003 every 8 weeks using vial and syringe 3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\] | VRDN-003 VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Treatment Emergent Adverse Event (TEAE) incidence rate | Treatment Emergent Adverse Event (TEAE) incidence rate | Through Week 24 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Pharmacokinetic outcome measures | Time of maximum serum concentration (Tmax) of VRDN-003 | Through Week 24 |
Pharmacokinetic outcome measures | Maximum serum concentration (Cmax) of VRDN-003 | Through Week 24 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
- Not require immediate ophthalmological or orbital surgery in the study eye for any reason
- Must agree to use highly effective contraception as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
- Must not have received prior treatment with another anti-IGF-1R therapy
- Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
- Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose
- Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) prior to first dose
- Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
- Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
- Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
- Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor
- Must not have a history of inflammatory bowel disease
- Female TED participants must not be pregnant or breastfeeding
Viridian TherapeuticsAucune donnée de contact disponible
4 Centres de l'essai dans 1 pays
California
United Medical Research Institute, Inglewood, California, 90301, United States
Study Coordinator, Contact, 310-645-4673, [email protected]
En recrutement
Florida
Ilumina Medical Research, Kissimmee, Florida, 34744, United States
Study Coordinator, Contact, 407-807-6506, [email protected]
En recrutement
Hype Clinical Research, LLC, Miami, Florida, 33145, United States
Study Coordinator, Contact, 305-833-0053, [email protected]
En recrutement
Michigan
Fraser Eye Center, Fraser, Michigan, 48026, United States
Study Coordinator, Contact, 586-296-7250, [email protected]
En recrutement