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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name THRIVE

NCTNCT05176639 (opens ClinicalTrials.gov in a new tab)Other idVRDN-001-101
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
113 participants (actual)
Sponsor
Viridian Therapeutics, Inc. · Industry
Design
Randomized · Triple masking
Countries
7 countries

United States, Australia, France, Germany, Poland, Spain, United Kingdom

Start
16 Nov 2022
Primary completion
15 Jul 2024
Completion
27 Mar 2025
First posted
4 Jan 2022
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
20222023202420252026
  1. Ph 3

    THRIVE

    NCT05176639

    16 Nov 2022 to 27 Mar 2025

Registry summary

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

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 participants 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 participants who received 10 milligrams (mg)/kilogram (kg).

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.

  • Placebo comparator

    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 Study Eye As Measured by Exophthalmometer

    Time frame · Baseline to Week 15

    Registry description

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

Secondary outcomes(9)

  1. Change From Baseline in Proptosis in the Study 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 Multiple Imputation method.

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

    Time frame · 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 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 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 Exophthalmometer Imputation method, as applicable.

  4. Change From Baseline in CAS in the Study Eye

    Time frame · Baseline, Week 15

    Registry description

    The CAS was based on 7 components: spontaneous retrobulbar pain, pain on attempted eye movements (upward, side to-side, and downward gazes), conjunctival redness, redness of the eyelids, chemosis, swelling of the caruncle or plica and swelling of the eyelids. Each component was scored as present or absent (scored as 1 or 0, respectively), and the CAS was given as the sum of the scores (range, 0 to 7, with higher scores indicating greater level of inflammation). Missing data were imputed with the Multiple Imputation method.

  5. Overall Responder Rate (ORR) Comprising of PRR and Clinical Activity Responder Rate in the Study Eye

    Time frame · Baseline to Week 15

    Registry description

    ORR in the study eye was comprised of PRR in the study eye (reduction of proptosis of ≥ 2 mm from baseline \[without a corresponding increase of ≥ 2 mm in the fellow eye\]) and clinical activity responder in the study eye (reduction in clinical activity score \[CAS\] ≥ 2 points from baseline \[without a corresponding increase of ≥ 2 points in the fellow eye\]). CAS ranged from 0 to 7, with higher scores indicating greater level of inflammation. Proptosis (distance between the lateral orbital rim and the most anterior position of the cornea in mm) was measured using an exophthalmometer. Missing data were imputed with Multiple Imputation method.

  6. Clinical Activity Responder Rate in the Study Eye

    Time frame · Week 15

    Registry description

    Clinical activity responder rate in the study eye was defined as a reduction in CAS ≥2 points from baseline in the study eye (without a corresponding increase of ≥2 points in the fellow eye). Missing data were imputed with the Multiple Imputation method.

  7. Diplopia Responder Rate

    Time frame · Week 15

    Registry description

    Diplopia responder was defined as reduction in Gorman subjective diplopia score of ≥1 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 Multiple Imputation method.

  8. 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 Multiple Imputation method.

  9. Percentage of Participants With a CAS of 0 or 1 in the Study Eye

    Time frame · Week 15

    Registry description

    The CAS was based on 7 components: spontaneous retrobulbar pain, pain on attempted eye movements (upward, side to-side, and downward gazes), conjunctival redness, redness of the eyelids, chemosis, swelling of the caruncle or plica and swelling of the eyelids. Each component was scored as present or absent (scored as 1 or 0, respectively), and the CAS was given as the sum of the scores (range, 0 to 7, with higher scores indicating greater level of inflammation). Missing data were imputed with the Multiple Imputation 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 Study Eye As Measured by Exophthalmometer

GroupValue (percentage of participants)
Veligrotug70.00
Placebo5.26
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 15

Change From Baseline in Proptosis in the Study Eye As Measured by Exophthalmometer

GroupValue (mm)Spread
Veligrotug-2.900.18
Placebo-0.480.24
Secondary outcomeNumber· Week 15

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

GroupValue (percentage of participants)
Veligrotug70.79
Placebo9.36
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-2.960.19
Placebo-0.580.27
Secondary outcomeLeast squares mean· Baseline, Week 15

Change From Baseline in CAS in the Study Eye

GroupValue (units on a scale)Spread
Veligrotug-3.420.16
Placebo-1.700.22
Secondary outcomeNumber· Baseline to Week 15

Overall Responder Rate (ORR) Comprising of PRR and Clinical Activity Responder Rate in the Study Eye

GroupValue (percentage of participants)
Veligrotug66.83
Placebo5.26
Secondary outcomeNumber· Week 15

Clinical Activity Responder Rate in the Study Eye

GroupValue (percentage of participants)
Veligrotug92.97
Placebo52.66
Secondary outcomeNumber· Week 15

Diplopia Responder Rate

GroupValue (percentage of participants)
Veligrotug59.07
Placebo19.89

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.0 / 757 / 7563 / 75
PlaceboParticipants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.0 / 380 / 3819 / 38

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
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 within 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.

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