Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
322
Countries
4
Sites
22
Thyroid eye disease
To evaluate if VRDN-003 is safe and tolerable (meaning if the body reacts acceptably to VRDN-003) when administered as a series of subcutaneous/SC (injection into layer of fat between skin and muscle) injections given every 4 weeks or every 8 weeks in participants with TED of any duration.
Key facts
- Sponsor
- Viridian Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 25 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Viridian Therapeutics Inc.
External identifiers
- EU CT number
- 2024-519417-57-00
- ClinicalTrials.gov
- NCT06812325
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Pharmacokinetic
To evaluate if VRDN-003 is safe and tolerable (meaning if the body reacts acceptably to VRDN-003) when administered as a series of subcutaneous/SC (injection into layer of fat between skin and muscle) injections given every 4 weeks or every 8 weeks in participants with TED of any duration.
Conditions and MedDRA coding
Thyroid eye disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10060742 | Endocrine ophthalmopathy | 100000004853 |
| 23.1 | LLT | 10084358 | Thyroid eye disease | 100000004848 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult males or females, ≥18 to ≤75 years of age
- Have a clinical diagnosis of TED of any duration and in the opinion of the Investigator may benefit from VRDN-003
- Must agree to use highly effective contraception as specified in the protocol
- Female participants must have a negative pregnancy test at first study visit
Exclusion criteria 7
- Received prior treatment with another anti-IGF-1R therapy
- 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.
- 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.
- 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
- Have abnormal hearing test before first dose. History of ear conditions considered significant by study doctor
- Have inflammatory bowel disease (conditions that involve inflammation of the gastrointestinal [GI] tract)
- Female participants who are pregnant or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 2
- Changes in eye bulging at Week 24 versus measurements before the first dose.
- The rate at which safety events occur after starting treatment with VRDN-003 through study completion.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
VRDN (Insulin-like growth factor-1 receptor [IGF-1R] inhibitor with half-life extension)
PRD11512817 · Product
- Active substance
- VRDN-003
- Pharmaceutical form
- INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2100 mg milligram(s)
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- VIRIDIAN THERAPEUTICS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Viridian Therapeutics Inc.
- Sponsor organisation
- Viridian Therapeutics Inc.
- Address
- 221 Crescent Street Suite 103a
- City
- Waltham
- Postcode
- 02453-3425
- Country
- United States
Scientific contact point
- Organisation
- Viridian Therapeutics Inc.
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- Viridian Therapeutics Inc.
- Contact name
- Chief Medical Officer
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| CluePoints INC ORL-000002186
|
King of Prussia, United States | Other |
| Hearx SA (Pty) Ltd. ORG-100052375
|
Pretoria, South Africa | Other |
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Acm Medical Laboratory Inc. ORG-100042792
|
Rochester, United States | Laboratory analysis |
| Arup Laboratories Inc. ORG-100041750
|
Salt Lake City, United States | Laboratory analysis |
| Leapcure Inc. ORL-000003865
|
Redwood City, CA, United States | Code 2 |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, Code 8 |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Kcas LLC ORG-100043073
|
Olathe, United States | Laboratory analysis |
| Xerimis Inc. ORG-100045410
|
Moorestown, United States | Code 14, Laboratory analysis |
| The Doctors Laboratory Limited ORG-100012670
|
London, United Kingdom | Laboratory analysis |
Locations
4 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 9 | 3 |
| Germany | Ongoing, recruitment ended | 46 | 4 |
| Poland | Ongoing, recruitment ended | 68 | 8 |
| Spain | Ongoing, recruitment ended | 17 | 7 |
| Rest of world
Turkey, United Kingdom, United States
|
— | 182 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
1512;, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Hospices Civils De Lyon
1508;, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Centre Hospitalier Universitaire D'Angers
1502: Service d'Endocrinologie, Diabétologie et Nutrition, 4 Rue Larrey, 49100, Angers
Universitaetsklinikum Essen AöR
1604:Klinik für Augenheilkunde, Hufelandstrasse 55, Holsterhausen, Essen
Charite Universitaetsmedizin Berlin KöR
1603:Klinik für Augenheilkunde, Augustenburger Platz 1, Wedding, Berlin
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
1605:Endokrinologie & Stoffwechselerkranknugen, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsmedizin Goettingen
1602:Klinik für Augenheilkunde, Robert-Koch-Strasse 40, Weende, Goettingen
Santa Sp. z o.o.
2208; Santa Familia PTG Lodz, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
ETG Lublin Sp. z o.o.
2215; ETG Lublin, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Warszawski Szpital Okulistyczny Sp. z o.o.
2212; Warszawski Szpital Okulistyczny, Ul. Wolska 165/u7, 01-258, Warsaw
Uniwersytecki Szpital Kliniczny W Bialymstoku
2201; Klinika Okulistyki, Centrum Badan Klinicznych, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Pratia S.A.
2213; Centrum Medyczne Pratia Gdynia, Ul. Chrzanowskiego 3 Lok 5, 81-338, Gdynia
Centrum Medyczne Pulawska Sp. z o.o.
2203; Centrum Medyczne Pulawska Sp. z o.o., Ul. Pulawska 49, 05-500, Piaseczno
Polimedica Centrum Badan Profilaktyki I Leczenia Sp. z o.o.
2216; Polimedica PTG, Ul. Belgradzka 52/54, Ursynow, Warsaw
Profesorskie Centrum Medyczne Sp. z o.o.
2204; opthalmology, Ul. Warszawska 20, 80-180, Gdansk
Clinica Universidad De Navarra
2112: Oftalmología, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Virgen De La Macarena
2101: Oftalmología, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Complexo Hospitalario Universitario De Santiago
2104: Oftalmología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Miguel Servet
2105: Oftalmología, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Metavision Arruzafa S.L.
2106: Oftalmología, Avenida De La Arruzafa 9, 14012, Cordoba
Hospital Universitario Ramon Y Cajal
2103: Oftalmología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Institut Catala De Retina S.L.
2115: Oftalmología, Calle De La Pau Alcover 67, 08017, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-09-15 | 2025-09-15 | 2025-09-29 | ||
| Germany | 2025-08-01 | 2025-08-13 | 2025-09-30 | ||
| Poland | 2025-06-25 | 2025-07-08 | 2025-09-30 | ||
| Spain | 2025-07-10 | 2025-08-20 | 2025-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 29 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Main English VRDN-003-303 Public | 3.0 |
| Recruitment arrangements (for publication) | K1_DEU Recruitment Procedure Description English VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Flyer Spanish VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Other PAO Tile Spanish VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Poster Spanish VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_FRA Recruitment Procedure Description French English VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_POL Recruitment Procedure Description English Polish VRDN-003-303 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_DEU Recruitment Flyer German VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_DEU Recruitment Other PAO Tile German VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_DEU Recruitment Poster German VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Procedure Description English VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Flyer French VRDN-003-303 Public | 1.1 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Other PAO Tile French VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Poster French VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_POL Recruitment Flyer Polish VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_POL Recruitment Other PAO Tile Polish VRDN-003-303 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_POL Recruitment Poster Polish VRDN-003-303 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main German VRDN-003-303 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Other Pregnant Part Particip German VRDN-003-303 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish VRDN-003-303 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Other Pregnant Participant Partner Spanish VRDN-003-303 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main French VRDN-003-303 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Other Pregnancy French VRDN-003-303 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Adult Polish VRDN-003-303 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Other Pregnant Participant and Partner Polish VRDN-003-303 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main English VRDN-003-303 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main French VRDN-003-303 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Polish VRDN-003-303 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Spanish VRDN-003-303 Public | 4.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-21 | Spain | Acceptable 2025-06-05
|
2025-06-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-01 | Spain | Acceptable 2025-09-03
|
2025-09-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-21 | Spain | Acceptable 2025-09-03
|
2025-10-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-12 | Spain | Acceptable 2026-04-21
|
2026-04-23 |