En randomiseret, dobbeltmaskeret, placebo-kontrolleret undersøgelse af sikkerhed, tolerabilitet og effektivitet af VRDN-001, et humaniseret monoklonalt antistof rettet mod IGF-1-receptoren, hos deltagere med kronisk skjoldbruskkirteløjensygdom (TED) (THRIVE-2)
22. juli 2026 opdateret af: Viridian Therapeutics, Inc.
Et randomiseret, dobbeltmasket, placebokontrolleret sikkerheds-, tolerabilitets- og effektstudie af VRDN-001 hos deltagere med kronisk skjoldbruskkirteløjensygdom (TED)
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
En randomiseret, dobbeltmasket, placebokontrolleret undersøgelse af sikkerhed, tolerabilitet og effektivitet af VRDN-001, et humaniseret monoklonalt antistof rettet mod IGF-1-receptoren, hos deltagere med kronisk skjoldbruskkirteløjensygdom (TED)
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
188
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Saint Leonards, New South Wales, Australien, 2065
- North Shore Private Hospital
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London, Det Forenede Kongerige, SE1 7EH
- St. Thomas' Hospital
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London, Det Forenede Kongerige, EC1V 2PD
- Moorfields Eye Hospital
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London, Det Forenede Kongerige, NW1 5QH
- Imperial College Healthcare NHS Trust - Western eye Hospital
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Newcastle, Det Forenede Kongerige, NEI 4LP
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Southampton, Det Forenede Kongerige, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
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California
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Los Angeles, California, Forenede Stater, 90023
- Advancing Research International, LLC
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Los Angeles, California, Forenede Stater, 90089
- USC Roski Eye Institute
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Newport Beach, California, Forenede Stater, 92660
- Amy Patel Jain, MD
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Palo Alto, California, Forenede Stater, 94303
- Stanford Byers Eye Institute
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San Diego, California, Forenede Stater, 92108
- Cockerham Eye Consultants, PC
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Florida
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Miami, Florida, Forenede Stater, 33136
- Bascom Palmer Eye Institute - Ophthalmology - Miami
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Sarasota, Florida, Forenede Stater, 34239
- Sarasota Retina Institute
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Oak Lawn, Illinois, Forenede Stater, 60453
- Family Eye Physicians, Ltd
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts Eye and Ear
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Boston, Massachusetts, Forenede Stater, 02189
- Ophthalmic Consultants of Boston
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Michigan
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East Lansing, Michigan, Forenede Stater, 48824
- Michigan State University, Department of Neurology
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Livonia, Michigan, Forenede Stater, 48152
- Kahana Oculoplastic and Orbital Surgery
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine in St Louis - Ophthalmology
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89144
- Steven Leibowitz, MD.
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New Jersey
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Newark, New Jersey, Forenede Stater, 07103
- Rutgers - New Jersey Medical School
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Somerset, New Jersey, Forenede Stater, 08873
- The Center for Eye and Facial Plastic Surgery
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Wills Eye Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Department of Ophthalmology, University of Pennsylvania
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Texas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine (BCM) - Ophthalmology
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Houston, Texas, Forenede Stater, 77074
- Neuro Eye Clinical Trials
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- University of Vermont Medical Center
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Harborview Medical Center
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Angers, Frankrig, 49033
- CHU Angers
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Bordeaux, Frankrig, 33000
- CHU de Bordeaux - Hôpital Saint-André
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Nantes, Frankrig, 44093
- Centre Hospitalier Universitaire De Nantes - G. R. Laennec
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Nice, Frankrig, 06000
- CH Nice
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Bialystok, Polen, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Bialystok, Polen, 85-157
- Oculomedica Sp. z o.o.
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Gdansk, Polen, 80-809
- Optimum Profesorskie Centrum Okulistyki sp. z o.o.
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Piaseczno, Polen, 05-500
- Centrum Medyczne Pulawska Sp. z o.o.
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Wałbrzych, Polen, 58-304
- Centrum Medyczne Piasta 47 sp. z o.o.
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A Coruña, Spanien, 15706
- Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
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Barcelona, Spanien, 08021
- Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre)
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Córdoba, Spanien, 14012
- Hospital La Arruzafa
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Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
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Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Spanien, 41009
- Hospital Universitario Virgen De La Macarena
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Valencia, Spanien, 46026
- Hospital Universitario y Politécnico La Fe
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Zaragoza, Spanien, 50009
- Hospital Unviersitario Miguel Servet
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Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi
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Ankara, Tyrkiet (Türkiye), 06500
- Gazi University Medical Faculty Hospital
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Antalya, Tyrkiet (Türkiye), 07059
- Akdeniz University Medical Faculty Hospital
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Istanbul, Tyrkiet (Türkiye), 34854
- Marmara University Faculty of Medicine
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Berlin, Tyskland, 13353
- Charité - Universitätsmedizin Berlin KöR
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Essen, Tyskland, 45122
- Universitätsklinikum Essen AöR
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Freiburg im Breisgau, Tyskland, 79106
- University Medical Center Freiburg
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Göttingen, Tyskland, 37075
- Universitätsmedizin Göttingen
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Budapest, Ungarn, H-1133
- Budapest Retina Intezet
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Pécs, Ungarn, H-7621
- Ganglion Orvosi Központ
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Pécs, Ungarn, H-7623
- Pecsi Tudomanyegyetem Klinikai Kozpont Szemeszeti Klinika
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Skal have moderat til svær kronisk TED med dokumenteret tegn på okulære symptomer eller tegn, der begyndte inden for 15 måneder før screening
- Skal have Clinical Activity Score (CAS) på (0-7) emneskala for undersøgelsens (mere proptotisk) øje
- Skal acceptere at bruge højeffektiv prævention som specificeret i protokollen
- Kvindelige TED-deltagere skal have en negativ serumgraviditetstest
Nøgleekskluderingskriterier:
- Må ikke have modtaget tidligere behandling med et andet anti-IGF-1R monoklonalt antistof
- Må ikke have brugt orale kortikosteroider inden for 2 uger før dag 1
- Må ikke have modtaget rituximab, tocilizumab eller andre immunsuppressive midler inden for 8 uger før dag 1
- Må ikke have en allerede eksisterende oftalmisk tilstand i undersøgelsesøjet, som efter investigators mening ville forvirre fortolkningen af undersøgelsesresultaterne
- Må ikke have haft tidligere orbital bestråling eller operation for TED i undersøgelsesøjet
- Må ikke have en historie med inflammatorisk tarmsygdom
- Må ikke have en anamnese eller screeningsaudiometrivurdering af klinisk signifikant (som bestemt af investigator) ørepatologi, relevant ørekirurgi eller høretab
- Må ikke have modtaget en undersøgelsesagent for nogen tilstand
- Kvindelige TED-deltagere må ikke være gravide eller ammende
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Veligrotug
Participants will receive veligrotug 10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.
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5 IV Infusions of veligrotug 10 mg/kg
Andre navne:
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Eksperimentel: Placebo
Participants will receive placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
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5 IV Infusions of veligrotug matched placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proptosis Responder Rate (PRR) in the Most Proptotic Eye as Measured by Exophthalmometer
Tidsramme: Baseline to Week 15
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Proptosis response in the most proptotic eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the most proptotic eye (without a corresponding increase of ≥2 mm in the other eye) as measured by exophthalmometer.
Missing data were imputed with the Multiple Imputation (MI) method.
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Baseline to Week 15
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by Exophthalmometer
Tidsramme: Baseline, Week 15
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Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in mm, measured using an exophthalmometer.
Missing data were imputed with the MI method.
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Baseline, Week 15
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PRR in the Most Proptotic Eye, as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT)
Tidsramme: Baseline to Week 15
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Proptosis responder in the most proptotic eye by MRI/CT was defined as a reduction of proptosis of ≥2 mm from baseline in the most proptotic eye by MRI/CT (without a corresponding increase of ≥2 mm in the other eye) as measured by MRI/CT.
Missing data were imputed using the Exophthalmometer Imputation (EXI) method, as applicable.
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Baseline to Week 15
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Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by MRI/CT
Tidsramme: Baseline, Week 15
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Measurement of proptosis was conducted by the central imaging reading center using MRI/CT of the orbits acquired without contrast.
Measurements were conducted by 2 independent readers with adjudication if the difference between the 2 primary readers in proptosis measurement exceeded 5% (calculated as the difference divided by the larger measurement).
The average of 2 (or 3 if adjudicated) measurements were used for analyses.
Missing data were imputed using the EXI method, as applicable.
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Baseline, Week 15
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Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer
Tidsramme: Week 15
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Clinical activity responder in the most proptotic eye was defined as no worsening in clinical activity score (CAS) from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye.
Missing data were imputed with the MI method.
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Week 15
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Overall Responder Rate (ORR) Comprising PRR and Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer
Tidsramme: Baseline to Week 15
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ORR was comprised of PRR in the most proptotic eye (reduction of proptosis of ≥2 mm from baseline in the most proptotic eye [without a corresponding increase of ≥2 mm in the other eye]) as measured by exophthalmometer at Week 15 and Clinical Activity Responder rate in the most proptotic eye (no worsening in CAS from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye) as measured by exophthalmometer at Week 15.
Missing data were imputed with the MI method.
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Baseline to Week 15
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Diplopia Responder Rate
Tidsramme: Week 15
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A diplopia responder was defined as having a decrease of ≥1 from baseline for participants with a baseline Gorman subjective diplopia score >0.
Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
Missing data were imputed with the MI method.
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Week 15
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Diplopia Resolution Rate
Tidsramme: Week 15
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Diplopia resolution was defined as reduction in Gorman subjective diplopia score to 0 from baseline for participants with baseline Gorman subjective diplopia score >0.
Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
Missing data were imputed with the MI method.
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Week 15
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2023
Primær færdiggørelse (Faktiske)
4. november 2024
Studieafslutning (Faktiske)
25. juli 2025
Datoer for studieregistrering
Først indsendt
25. august 2023
Først indsendt, der opfyldte QC-kriterier
25. august 2023
Først opslået (Faktiske)
1. september 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Genetiske sygdomme, medfødte
- Autoimmune sygdomme
- Sygdomme i immunsystemet
- Øjensygdomme
- Øjensygdomme, arvelig
- Eksophthalmos
- Orbitale sygdomme
- Struma
- Hyperthyroidisme
- Skjoldbruskkirtelsygdomme
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Graves Oftalmopati
- Graves sygdom
Andre undersøgelses-id-numre
- VRDN-001-301
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
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Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .