Clinical trial • Phase III • Ophthalmology

VRDN-003 for Thyroid eye disease | Endocrine ophthalmopathy

Phase III trial of VRDN-003 for Thyroid eye disease | Endocrine ophthalmopathy.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Thyroid eye disease | Endocrine ophthalmopathy
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
21-02-2025
First CTIS Authorization Date
05-06-2025

Trial design

Randomised, ted sc placebo (placebo comparator; schedule to match vrdn-003 dosing; exact placebo dose not specified)-controlled Phase III trial in Poland, Germany, Spain and others.

Randomised
Yes
Comparator
TED SC Placebo (placebo comparator; schedule to match VRDN-003 dosing; exact placebo dose not specified)
Target Sample Size
182
Trial Duration For Participant
168

Eligibility

Recruits 182 isVulnerablePopulationSelected is true in the registry. The trial population is adults (≥18). Informed consent is to be obtained from adult participants; country-specific subject information and informed consent forms (Main Adult ICFs and separate Pregnancy/Partner ICFs) are provided for Poland, Germany, Spain and France. No assent/parental consent procedures for minors are provided (minors are excluded)..

Pregnancy Exclusion
Female participants who are pregnant or breastfeeding
Vulnerable Population
isVulnerablePopulationSelected is true in the registry. The trial population is adults (≥18). Informed consent is to be obtained from adult participants; country-specific subject information and informed consent forms (Main Adult ICFs and separate Pregnancy/Partner ICFs) are provided for Poland, Germany, Spain and France. No assent/parental consent procedures for minors are provided (minors are excluded).

Inclusion criteria

  • {"criterion_text":"- Adult males or females, ≥18 to ≤75 years of age\n- Have a clinical diagnosis of TED of any duration and in the opinion of the Investigator may benefit from VRDN-003\n- Must agree to use highly effective contraception as specified in the protocol\n- Female participants must have a negative pregnancy test at first study visit"}

Exclusion criteria

  • {"criterion_text":"- Received prior treatment with another anti-IGF-1R therapy\n- Received corticosteroids (drugs that reduce inflammation in the body) or steroid eye drops for any condition, including TED, within 2 weeks prior to first dose.\n- Received other immunosuppressive drugs (drugs that dampen the body’s immune response) or any other therapy for TED within 12 weeks prior to first dose or another investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose.\n- Have had previous orbital irradiation or decompression surgery for TED or a preexisting eye condition which in the study doctor’s opinion, would interfere with interpretation of study results\n- Have had abnormal hearing test before first dose. History of ear conditions considered significant by study doctor\n- Have inflammatory bowel disease (conditions that involve inflammation of the gastrointestinal [GI] tract)\n- Female participants who are pregnant or breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary study endpoint will assess the rate at which safety events occur after starting treatment with VRDN-003 (Treatment Emergent Adverse Event) through Week 24.","definition_or_measurement_approach":"Assessment of the rate at which safety events (Treatment Emergent Adverse Events) occur after starting VRDN-003 through Week 24."}

Secondary endpoints

  • {"endpoint_text":"- Changes in eye bulging at Week 24 versus measurements before the first dose.","definition_or_measurement_approach":"Change in ocular protrusion (eye bulging) at Week 24 compared with pre-dose (baseline) measurements."}
  • {"endpoint_text":"- The rate at which safety events occur after starting treatment with VRDN-003 through study completion.","definition_or_measurement_approach":"Assessment of the rate/frequency of safety events (Treatment Emergent Adverse Events) from treatment start through study completion."}

Recruitment

Planned Sample Size
182
Recruitment Window Months
19
Consent Approach
Informed consent to be obtained from adult participants. Country-specific Main Adult ICFs are provided (L1 Country ICF Main documents in Polish, German, Spanish, French). Separate ICF documents for pregnant participants and partner are provided. No procedures for assent/parental consent for minors are provided (minors excluded).

Methods

  • Country-specific recruitment materials and procedures documented (K1/K2): recruitment flyers, posters and PAO tiles and recruitment procedure description documents are provided for Poland, Germany, Spain and France (documents listed under Recruitment arrangements).
  • Use of country language ICF and country-specific recruitment materials (e.g. K2 posters/flyers) targeted at patients with Thyroid Eye Disease (TED) in each listed country.

Geography

Total Number Of Sites
22
Total Number Of Participants
140

Poland

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
344
Number Of Sites
8
Number Of Participants
68

Sites

Site Name
Centrum Medyczne Pulawska Sp. z o.o.
Department Name
2203; Centrum Medyczne Pulawska Sp. z o.o.
Contact Person Name
Malgorzata Zaras
Contact Person Email
malgorzata.zaras@cmp.med.pl
Site Name
Warszawski Szpital Okulistyczny Sp. z o.o.
Department Name
2212; Warszawski Szpital Okulistyczny
Contact Person Name
Agnieszka Nowosielska
Contact Person Email
nowosielska.aga@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
2201; Klinika Okulistyki, Centrum Badan Klinicznych
Contact Person Name
Joanna Konopinska
Contact Person Email
joannakonopinska@o2.pl
Site Name
ETG Lublin Sp. z o.o.
Department Name
2215; ETG Lublin
Contact Person Name
Iwona Chmiel - Perzynska
Site Name
Santa Sp. z o.o.
Department Name
2208; Santa Familia PTG Lodz
Contact Person Name
Michal Nowak
Contact Person Email
michaelnovak@interia.pl
Site Name
Pratia S.A.
Department Name
2213; Centrum Medyczne Pratia Gdynia
Contact Person Name
Ewa Purzycka - Kopczynska
Contact Person Email
epurzycka-kopczynska@pratia.pl
Site Name
Polimedica Centrum Badan Profilaktyki I Leczenia Sp. z o.o.
Department Name
2216; Polimedica PTG
Contact Person Name
Magdalena Guminska
Site Name
Profesorskie Centrum Medyczne Sp. z o.o.
Department Name
2204; opthalmology
Contact Person Name
Dorota Raczynska
Contact Person Email
draczynska@op.pl

Germany

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
346
Number Of Sites
4
Number Of Participants
46

Sites

Site Name
Universitaetsmedizin Goettingen
Department Name
1602:Klinik für Augenheilkunde
Contact Person Name
Maren Horn
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
1603:Klinik für Augenheilkunde
Contact Person Name
Eckart Bertelmann
Contact Person Email
Eckart.bertelmann@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
1605:Endokrinologie & Stoffwechselerkranknugen
Contact Person Name
George Kahaly
Site Name
Universitaetsklinikum Essen AöR
Department Name
1604:Klinik für Augenheilkunde
Contact Person Name
Anja Eckstein
Contact Person Email
anja.eckstein@uk-essen.de

Spain

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
350
Number Of Sites
7
Number Of Participants
17

Sites

Site Name
Metavision Arruzafa S.L.
Department Name
2106: Oftalmología
Contact Person Name
Javier Vicente Andreu
Contact Person Email
jvicente@hospitalarruzafa.com
Site Name
Hospital Universitario Miguel Servet
Department Name
2105: Oftalmología
Contact Person Name
Luis Emilio Pablo Júlvez
Contact Person Email
lpablo@unizar.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
2101: Oftalmología
Contact Person Name
Antonio Manuel Garrido Hermosilla
Contact Person Email
gaherfamily@hotmail.com
Site Name
Institut Catala De Retina S.L.
Department Name
2115: Oftalmología
Contact Person Name
Nuria Ibañez Flores
Contact Person Email
nibanez@uic.es
Site Name
Clinica Universidad De Navarra
Department Name
2112: Oftalmología
Contact Person Name
Jesús Barrio
Contact Person Email
jbarrio@unav.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
2104: Oftalmología
Contact Person Name
José Manuel Abalo Lojo
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
2103: Oftalmología
Contact Person Name
Marco Sales Sanz
Contact Person Email
marco.sales@salud.madrid.org

France

Earliest CTIS Part Ii Submission Date
28-04-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
360
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
1512;
Contact Person Name
Camille Buffet
Contact Person Email
camille.buffet@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
1508;
Contact Person Name
Juliette Abeillon Du Payrat
Contact Person Email
juliette.abeillon@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
1502: Service d'Endocrinologie, Diabétologie et Nutrition
Contact Person Name
Patrice Rodien
Contact Person Email
parodien@chu-angers.fr

Sponsor

Primary sponsor

Full Name
Viridian Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Codes: 1,10,11,12,13,2,5,6,8
Name
Suvoda LLC
Name
Medidata Solutions Inc.

Third parties

  • {"country":"United States","full_name":"CluePoints INC","duties_or_roles":"Centralized data monitoring","organisation_type":"Industry"}
  • {"country":"South Africa","full_name":"Hearx SA (Pty) Ltd.","duties_or_roles":"audiometry assessments","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Leapcure Inc.","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Codes: 1,10,11,12,13,2,5,6,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Subject reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Xerimis Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
VRDN (Insulin-like growth factor-1 receptor [IGF-1R] inhibitor with half-life extension)
Active Substance
VRDN-003
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
PRD11512817 (prodAuthStatus:1)
Frequency
Every 4 weeks or every 8 weeks
Maximum Dose
600 mg daily; max total 2100 mg
Investigational Product Name
TED SC Placebo
Modality
Other

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