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Viridian TherapeuticsA Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07155668 untersucht Behandlung im Zusammenhang mit Schilddrüsenaugenerkrankung. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 1. Juli 2025. Es ist geplant, 75 Teilnehmer aufzunehmen. Durchgeführt von Viridian Therapeutics wird der Abschluss für 1. November 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 4. September 2025 aktualisiert.
Kurzbeschreibung
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)
Ausführliche Beschreibung
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.
Offizieller Titel
A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)
Erkrankungen
SchilddrüsenaugenerkrankungWeitere Studien-IDs
- VRDN-003-304
NCT-Nummer
Studienbeginn (tatsächlich)
2025-07-01
Zuletzt aktualisiert
2025-09-04
Studienende (vorauss.)
2026-11
Geplante Rekrutierung
75
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellVRDN-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 |
ExperimentellVRDN-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 |
ExperimentellVRDN-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). |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Treatment Emergent Adverse Event (TEAE) incidence rate | Treatment Emergent Adverse Event (TEAE) incidence rate | Through Week 24 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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 Therapeutics5 aktive klinische Studien zum ErkundenKeine Kontaktdaten vorhanden
4 Studienstandorte in 1 Ländern
California
United Medical Research Institute, Inglewood, California, 90301, United States
Study Coordinator, Kontakt, 310-645-4673, [email protected]
Offene Rekrutierung
Florida
Ilumina Medical Research, Kissimmee, Florida, 34744, United States
Study Coordinator, Kontakt, 407-807-6506, [email protected]
Offene Rekrutierung
Hype Clinical Research, LLC, Miami, Florida, 33145, United States
Study Coordinator, Kontakt, 305-833-0053, [email protected]
Offene Rekrutierung
Michigan
Fraser Eye Center, Fraser, Michigan, 48026, United States
Study Coordinator, Kontakt, 586-296-7250, [email protected]
Offene Rekrutierung