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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name THRIVE-2

NCTNCT06021054 (opens ClinicalTrials.gov in a new tab)Other idVRDN-001-301
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names IGF-1 (mecasermin), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 3
Enrollment
188 participants (actual)
Sponsor
Viridian Therapeutics, Inc. · Industry
Design
Randomized · Triple masking
Countries
9 countries

United States, Australia, France, Germany, Hungary, Poland, Spain, Turkey (Türkiye), United Kingdom

Start
1 Nov 2023
Primary completion
4 Nov 2024
Completion
25 Jul 2025
First posted
1 Sept 2023
Last update posted
13 Aug 2026
Conditions
Thyroid Eye Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    THRIVE-2

    NCT06021054

    1 Nov 2023 to 25 Jul 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • VeligrotugDrug
  • PlaceboDrug

Arms2

  • Experimental

    Veligrotug

    Participants will receive veligrotug 10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.

  • Experimental

    Placebo

    Participants will receive placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proptosis Responder Rate (PRR) in the Most Proptotic Eye as Measured by Exophthalmometer

    Time frame · Baseline to Week 15

    Registry description

    Proptosis response in the most proptotic eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the most proptotic eye (without a corresponding increase of ≥2 mm in the other eye) as measured by exophthalmometer. Missing data were imputed with the Multiple Imputation (MI) method.

Secondary outcomes(7)

  1. Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by Exophthalmometer

    Time frame · Baseline, Week 15

    Registry description

    Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in mm, measured using an exophthalmometer. Missing data were imputed with the MI method.

  2. PRR in the Most Proptotic Eye, as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT)

    Time frame · Baseline to Week 15

    Registry description

    Proptosis responder in the most proptotic eye by MRI/CT was defined as a reduction of proptosis of ≥2 mm from baseline in the most proptotic eye by MRI/CT (without a corresponding increase of ≥2 mm in the other eye) as measured by MRI/CT. Missing data were imputed using the Exophthalmometer Imputation (EXI) method, as applicable.

  3. Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by MRI/CT

    Time frame · Baseline, Week 15

    Registry description

    Measurement of proptosis was conducted by the central imaging reading center using MRI/CT of the orbits acquired without contrast. Measurements were conducted by 2 independent readers with adjudication if the difference between the 2 primary readers in proptosis measurement exceeded 5% (calculated as the difference divided by the larger measurement). The average of 2 (or 3 if adjudicated) measurements were used for analyses. Missing data were imputed using the EXI method, as applicable.

  4. Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer

    Time frame · Week 15

    Registry description

    Clinical activity responder in the most proptotic eye was defined as no worsening in clinical activity score (CAS) from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye. Missing data were imputed with the MI method.

  5. Overall Responder Rate (ORR) Comprising PRR and Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer

    Time frame · Baseline to Week 15

    Registry description

    ORR was comprised of PRR in the most proptotic eye (reduction of proptosis of ≥2 mm from baseline in the most proptotic eye \[without a corresponding increase of ≥2 mm in the other eye\]) as measured by exophthalmometer at Week 15 and Clinical Activity Responder rate in the most proptotic eye (no worsening in CAS from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye) as measured by exophthalmometer at Week 15. Missing data were imputed with the MI method.

  6. Diplopia Responder Rate

    Time frame · Week 15

    Registry description

    A diplopia responder was defined as having a decrease of ≥1 from baseline for participants with a baseline Gorman subjective diplopia score \>0. Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Missing data were imputed with the MI method.

  7. Diplopia Resolution Rate

    Time frame · Week 15

    Registry description

    Diplopia resolution was defined as reduction in Gorman subjective diplopia score to 0 from baseline for participants with baseline Gorman subjective diplopia score \>0. Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Missing data were imputed with the MI method.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline to Week 15

Proptosis Responder Rate (PRR) in the Most Proptotic Eye as Measured by Exophthalmometer

GroupValue (percentage of participants)
Veligrotug57.28
Placebo8.22
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 15

Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by Exophthalmometer

GroupValue (mm)Spread
Veligrotug-2.350.16
Placebo-0.460.22
Secondary outcomeNumber· Baseline to Week 15

PRR in the Most Proptotic Eye, as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT)

GroupValue (percentage of participants)
Veligrotug46.40
Placebo3.17
Secondary outcomeLeast squares mean· Baseline, Week 15

Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by MRI/CT

GroupValue (mm)Spread
Veligrotug-2.020.12
Placebo-0.350.17
Secondary outcomeNumber· Week 15

Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer

GroupValue (percentage of participants)
Veligrotug99.52
Placebo93.56
Secondary outcomeNumber· Baseline to Week 15

Overall Responder Rate (ORR) Comprising PRR and Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer

GroupValue (percentage of participants)
Veligrotug57.25
Placebo6.63
Secondary outcomeNumber· Week 15

Diplopia Responder Rate

GroupValue (percentage of participants)
Veligrotug55.57
Placebo24.70
Secondary outcomeNumber· Week 15

Diplopia Resolution Rate

GroupValue (percentage of participants)
Veligrotug31.60
Placebo13.89

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
VeligrotugParticipants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.1 / 12510 / 12587 / 125
PlaceboParticipants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.0 / 633 / 6322 / 63

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria: * Must have moderate to severe chronic TED with documented evidence of ocular symptoms or 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 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 TED, or selenium within 2 weeks prior to first dose * Must not have received other immunosuppressive drugs or another investigational agent for any condition, including TED, or any other therapy for TED, within 8 weeks prior to first dose * Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose * Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the study doctor would confound interpretation of the study results * Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit * Must not have inflammatory bowel disease * Must not have abnormal baseline audiometry Pure Tone Average (PTA) assessment or history of significant (as determined by the Investigator) ear pathology, relevant ear surgery or hearing loss. * Female TED participants must not be pregnant or lactating

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