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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)

Short name STRIVE

NCTNCT06384547 (opens ClinicalTrials.gov in a new tab)Other idVRDN-001-303
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
231 participants (actual)
Sponsor
Viridian Therapeutics, Inc. · Industry
Design
Randomized · Double masking
Countries
7 countries

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

Start
23 May 2024
Primary completion
1 May 2025
Completion
19 Jan 2026
First posted
25 Apr 2024
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
2024202520262027
  1. Ph 3

    STRIVE

    NCT06384547

    23 May 2024 to 19 Jan 2026

Registry summary

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

The investigational drug, 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 TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.

Interventions

  • VeligrotugDrug

Arms2

  • Experimental

    Veligrotug 10 mg/kg

    Participants will receive 5 intravenous (IV) infusions of veligrotug 10 milligrams (mg)/kilogram (kg) at 3-week intervals for 12 weeks.

  • Experimental

    Veligrotug 3 mg/kg

    Participants will receive 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15

    Time frame · Baseline through Week 15

    Registry description

    An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Secondary outcomes(2)

  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 millimeters (mm), measured using an exophthalmometer. Observed change from baseline in proptosis in study eye is reported. Missing data were not imputed.

  2. Number of Participants With TEAEs Through Week 52

    Time frame · Baseline through Week 52

    Registry description

    An AE was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

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 outcomeCount of participants· Baseline through Week 15

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15

GroupValue (Participants)
Veligrotug 10 mg/kg153
Veligrotug 3 mg/kg55
Secondary and other outcome results(2)
Secondary outcomeMean· Baseline, Week 15

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

GroupValue (mm)Spread
Veligrotug 10 mg/kg-2.31.74
Veligrotug 3 mg/kg-2.11.42
Secondary outcomeCount of participants· Baseline through Week 52

Number of Participants With TEAEs Through Week 52

GroupValue (Participants)
Veligrotug 10 mg/kg159
Veligrotug 3 mg/kg55

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Veligrotug 10 mg/kgParticipants received 5 IV infusions of veligrotug 10 mg/kg at 3-week intervals for 12 weeks.0 / 17310 / 173142 / 173
Veligrotug 3 mg/kgParticipants received 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks.0 / 583 / 5847 / 58

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
Inclusion Criteria: * Have a clinical diagnosis of TED with or without proptosis and with any clinical activity score (CAS) (0 - 7) and in the opinion of the investigator may benefit from treatment * Must agree to use highly effective contraception method as specified in the protocol * Female TED participants must have a negative serum pregnancy test at screening * Not require immediate ophthalmological or orbital surgery in the study eye for any reason. Exclusion Criteria: * Must not have received prior treatment with another anti-IGF-1R therapy * 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 within 8 weeks prior to Day 1 * Must not have received 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 the first dose of study medication * 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 decompression surgery involving excision of fat for TED in the study eye's orbit * Must not have inflammatory bowel disease * Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor. * Female TED participants must not be pregnant or lactating.

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