An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants with Chronic Thyroid Eye Disease (TED) (THRIVE-2)

Last updated: September 25, 2024
Sponsor: Viridian Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dry Eye Disease

Treatment

Placebo

VRDN-001 10 mg/kg Drug:

Veligrotug (VRDN-001)

Clinical Study ID

NCT06021054
VRDN-001-301
  • Ages 18-75
  • All Genders

Study Summary

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Must have moderate to severe chronic TED with documented evidence of ocular symptomsor signs that began greater than 15 months prior to screening

  • Must have had a clinical diagnosis of TED, with any CAS (0-7)

  • Must agree to use highly effective contraception as specified in the protocol

  • Female TED participants must have a negative serum pregnancy test at screening

Exclusion

Key Exclusion Criteria:

  • Must not have received prior treatment with another anti-IGF-1R therapy

  • Must not have received systemic corticosteroids for any condition, including TEDwithin 2 weeks prior to first dose

  • Must not have received other immunosuppressive drugs or another investigationalagent for any condition, including TED, or any other therapy for TED, within 8 weeksprior to first dose

  • Must not have received radioactive iodine (RAI) treatment within 8 weeks prior tofirst dose

  • Must not have a pre-existing ophthalmic condition in the study eye that in theopinion of the study doctor would confound interpretation of the study results

  • Must not have had previous orbital irradiation or decompression surgery for TED tothe study eye's orbit

  • Must not have a history of inflammatory bowel disease

  • Must not have an abnormal hearing test before first dose or history of earconditions considered clinically significant by the study doctor

  • Female TED participants must not be pregnant or lactating

Study Design

Total Participants: 188
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 14, 2023
Estimated Completion Date:
September 30, 2025

Study Description

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if veligrotug (VRDN-001) is efficacious, safe, and tolerable when administered as 5 IV infusions given every 3 weeks for a total of 12 weeks in participants with chronic TED

Connect with a study center

  • North Shore Private Hospital

    Saint Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Shore Eye Surgery

    Saint Leonards, 2065
    Australia

    Active - Recruiting

  • CHU Angers

    Angers, 49033
    France

    Site Not Available

  • CHU de Bordeaux - Hopital Saint-Andre

    Bordeaux, 33075
    France

    Active - Recruiting

  • CHU de Bordeaux - Hôpital Saint-André

    Bordeaux, 33000
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire De Nantes - G. R. Laennec

    Nantes, 44093
    France

    Site Not Available

  • CH Nice

    Nice, 06000
    France

    Site Not Available

  • CHU Nice

    Nice, 06000
    France

    Active - Recruiting

  • Charita - Universitatsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin KöR

    Berlin, 13353
    Germany

    Site Not Available

  • University Eye Hospital Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitätsklinikum Essen AöR

    Essen, 45122
    Germany

    Site Not Available

  • University Eye Hospital

    Freiburg, 79106
    Germany

    Active - Recruiting

  • University Medical Center Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • University of Goettingen / Ophthalmology

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Universitätsmedizin Göttingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Budapest Retina Associates Kft.

    Budapest, H-1133
    Hungary

    Active - Recruiting

  • Budapest Retina Intezet

    Budapest, H-1133
    Hungary

    Site Not Available

  • Ganglion Orvosi Kozpont

    Pécs, H-7621
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem Klinikai Kozpont Szemeszeti Klinika

    Pécs, H-7623
    Hungary

    Site Not Available

  • University of Pecs

    Pécs, H-7623
    Hungary

    Active - Recruiting

  • Barzilai Medical Center

    Ashkelon, 7830604
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Auxologico San Luca

    Milano, 20149
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda

    Milano, 20122
    Italy

    Site Not Available

  • lstituto Auxologico Italiano

    Milano, 30122
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126
    Italy

    Active - Recruiting

  • Oculomedica Sp. z o. o.

    Białystok, 15-276
    Poland

    Active - Recruiting

  • Oculomedica Sp. z o.o.

    Białystok, 85-157
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Białystok, 15-276
    Poland

    Site Not Available

  • Optimum Profesorskie Centrum Okulistyki Sp. z o. o.

    Gdansk, 80-809
    Poland

    Active - Recruiting

  • Optimum Profesorskie Centrum Okulistyki Sp. z o.o.

    Gdansk, 80-809
    Poland

    Site Not Available

  • Centrum Medyczne Pulawska

    Piaseczno, 05-500
    Poland

    Active - Recruiting

  • Centrum Medyczne Pulawska Sp. z o.o.

    Piaseczno, 05-500
    Poland

    Site Not Available

  • Centrum Medyczne Piasta

    Wałbrzych, 58-304
    Poland

    Active - Recruiting

  • Centrum Medyczne Piasta 47 sp. z o.o.

    Wałbrzych, 58-304
    Poland

    Site Not Available

  • Centor de Oftalmologia Barraquer

    Barcelona, 08021
    Spain

    Active - Recruiting

  • Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre)

    Barcelona, 08021
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario de Santiago-Hospital

    Coruña, 15706
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo

    Coruña, 15706
    Spain

    Site Not Available

  • Hospital Arruzafa

    Córdoba, 14012
    Spain

    Active - Recruiting

  • Hospital La Arruzafa

    Córdoba, 14012
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitarlo Ram6n y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Umversitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen De La Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Y Politécnico La Fe

    Valence, 46026
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico

    Valence, 46026
    Spain

    Active - Recruiting

  • Hospital Unviersitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Gazi Oniversitesi Tip FakOltesi Hastanesi

    Ankara,
    Turkey

    Active - Recruiting

  • Gazi University Medical Faculty Hospital

    Ankara, 06500
    Turkey

    Site Not Available

  • Hacettepe Universitesi Tip Fak0ltesi

    Ankara,
    Turkey

    Active - Recruiting

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230
    Turkey

    Site Not Available

  • Akdeniz University Medical Faculty Hospital

    Antalya, 07059
    Turkey

    Site Not Available

  • Marmara University Faculty of Medicine

    Istanbul, 34854
    Turkey

    Site Not Available

  • Akdeniz Oniversitesi T,p FakOltesi. Goz Hastal,k.an

    Konya, 07070
    Turkey

    Site Not Available

  • Marmara University Pendik Education and Research Hospital

    Pendik, 34899
    Turkey

    Site Not Available

  • Guy's and St. Thomas NHS Trust

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS Trust - Western eye Hospital

    London, NW1 5QH
    United Kingdom

    Site Not Available

  • Imperial College Ophthalmic Research Group ICORG

    London, NW1 5QH
    United Kingdom

    Active - Recruiting

  • Moorfield's Eye Hospital

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital

    London, EC1V 2PD
    United Kingdom

    Active - Recruiting

  • Newcastle Eye Centre

    Newcastle, NEI 4LP
    United Kingdom

    Active - Recruiting

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NEI 4LP
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Advancing Research International, LLC

    Los Angeles, California 90023
    United States

    Site Not Available

  • MACRO Trials, Inc

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • USC Keck School of Medicine Department of Ophthalmology

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • USC Roski Eye Institute

    Los Angeles, California 90089
    United States

    Site Not Available

  • Amy Patel Jain, MD

    Newport Beach, California 92660
    United States

    Site Not Available

  • Amy Patel Jain, MD Inc

    Newport Beach, California 92660
    United States

    Active - Recruiting

  • Byers Eye Institute

    Palo Alto, California 94303
    United States

    Active - Recruiting

  • Stanford Byers Eye Institute

    Palo Alto, California 94303
    United States

    Site Not Available

  • Cockerham Eye Consultants, PC

    San Diego, California 92108
    United States

    Site Not Available

  • Senta Clinic

    San Diego, California 92108
    United States

    Active - Recruiting

  • Bascom Palmer Eye Institute - Ophthalmology - Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami/Bascom Palmer Eye Institute

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Sarasota Retina Institute

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Northwestern Medical Group, Department of Ophthalmology

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Family Eye Physicians, Ltd

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Vision Medical Research, INC

    Oak Lawn, Illinois 60453
    United States

    Active - Recruiting

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02189
    United States

    Site Not Available

  • Michigan State University Department of Neurology and Ophthalmology

    East Lansing, Michigan 48824
    United States

    Active - Recruiting

  • Michigan State University, Department of Neurology

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Kahana Oculoplastic and Orbital Surgery

    Livonia, Michigan 48152
    United States

    Site Not Available

  • Washington University School of Medicine in St Louis - Ophthalmology

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Steven Leibowitz, MD.

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Rutgers - New Jersey Medical School

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Rutgers New Jersey Medical

    Newark, New Jersey 07103
    United States

    Active - Recruiting

  • The Center for Eye and Facial Plastic Surgery

    Somerset, New Jersey 08873
    United States

    Site Not Available

  • Department of Ophthalmology, University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Wills Eye Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Wills Eye Hospital, Oculoplastics

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Eye Wellness Center- Neuro-Eye Clinical Trials, Inc.

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Baylor College of Medicine (BCM) - Ophthalmology

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor College of Medicine, Alkek Eye Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Neuro Eye Clinical Trials

    Houston, Texas 77074
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

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