A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507563-19-00

Acronym

VRDN-001-303

Enrollment

155

Registered

2024-10-28

Start date

2024-11-05

Completion date

Unknown

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid eye disease

Brief summary

Treatment Emergent Adverse Event (TEAE) incidence rate through Week 15

Detailed description

Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15, Treatment Emergent Adverse Event (TEAE) incidence rate through Week 52

Interventions

DRUGVRDN-001 (Insulin-like growth factor-1 receptor [IGF-1R] inhibitor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 15	—

Secondary

Measure	Time frame
Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15, Treatment Emergent Adverse Event (TEAE) incidence rate through Week 52	—

Countries

France, Germany, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026