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NCT Number: NCT05176639

A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )

The investigational drug, veligrotug (VRDN-001), is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to establish the safety, tolerability, and efficacy of veligrotug, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of veligrotug in active TED patients who received 10 mg/kg.

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Key information

Conditions

Thyroid Eye Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

North Shore Eye Surgery, Sydney, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria for Active TED Participants (THRIVE):

  • Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
  • Must have Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye
  • Must agree to use highly effective contraception as specified in the protocol
  • Female TED participants must have a negative serum pregnancy test at screening

Key Exclusion Criteria for Active TED Participants (THRIVE):

  • Must not have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED
  • Must not have used systemic corticosteroids or selenium within 2 weeks prior to Day 1
  • Must not have received rituximab, tocilizumab or other immunosuppressive agents or any other therapy for TED within 8 weeks prior to Day 1
  • Must not have received an investigational agent for any condition with 8 weeks prior to Day 1
  • Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
  • Must not have had previous orbital irradiation or surgery for TED in the study eye
  • Must not have a history of inflammatory bowel disease
  • Must not have a history of or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss
  • Female TED participants must not be pregnant or lactating

Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital decompression surgery limited to bone only are NOT exclusions.

Treatment and study plan

VRDN-001 Phase 3 Cohort (THRIVE)

Drug

5 IV Infusions of veligrotug (VRDN-001) 10mg/kg

VRDN-001 Placebo

Drug

5 IV Infusions of veligrotug (VRDN-001) placebo

Primary outcomes

  1. Proptosis Responder Rate

    Time frame: Week 15

    Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline [without a corresponding increase of ≥ 2 mm in the fellow eye] as measured by exophthalmometer)

Secondary outcomes

  1. Change from baseline in proptosis in the study eye

    Time frame: Week 15

    Change from baseline in proptosis in the study eye as measured by exophthalmometer

  2. Proptosis Responder Rate in the most proptotic eye

    Time frame: Week 15

    Proptosis Responder Rate in the most proptotic eye as measured by MRI/CT

  3. Change from baseline in proptosis in the most proptotic eye

    Time frame: Week 15

    Change from baseline in proptosis in the most proptotic eye as measured by MRI/CT

  4. Change from baseline in CAS

    Time frame: Week 15

    Change from baseline in Clinical Activity Score (CAS) in the study eye

  5. Overall Responder Rate

    Time frame: Week 15

    Overall Responder Rate comprising Proptosis Responder Rate as measured by exophthalmometer and Clinical Activity Responder Rate in the study eye

  6. Clinical Activity Responder Rate in the study eye

    Time frame: Week 15

    Clinical Activity Responder Rate in the study eye

  7. Diplopia Responder Rate

    Time frame: Week 15

    Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score >0)

  8. Diplopia Resolution Rate

    Time frame: Week 15

    Diplopia Resolution Rate (i.e., reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score >0)

  9. Proportion of participants with a CAS score of zero or one in the study eye

    Time frame: Week 15

    Proportion of participants with a CAS of zero or one in the study eye

Sponsors and collaborators

Lead sponsor

Viridian Therapeutics, Inc.

Industry

Registry information

Official study title

A Multiple Ascending Dose (MAD) Safety, Tolerability and Efficacy Study of Veligrotug (VRDN-001), a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Normal Healthy Volunteers (NHV(s) and Subjects With Thyroid Eye Disease (TED)

Acronym: THRIVE

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 4, 2022
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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