ClinicalTrials.Veeva

Menu
The trial is taking place at:
U

United Medical Research Institute | Inglewood, CA

Veeva-enabled site

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

V

Viridian Therapeutics

Status and phase

Enrolling
Phase 3

Conditions

Thyroid Eye Disease

Treatments

Drug: VRDN-001 10 mg/kg
Drug: VRDN-001 3 mg/kg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06384547
VRDN-001-303

Details and patient eligibility

About

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 patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.

Full description

A randomized, active 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)

Enrollment

212 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have a clinical diagnosis of TED with or without proptosis and with any 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

Exclusion criteria

  • Must not have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED
  • Must not have used systemic corticosteroids 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 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 a history or screening audiometry assessment of significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss
  • Must not have received an investigational agent for any condition within 8 weeks prior to Day 1
  • Female TED participants must not be pregnant or lactating

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

212 participants in 2 patient groups

VRDN-001 10 mg/kg
Experimental group
Description:
5 infusions of VRDN-001 10 mg/kg
Treatment:
Drug: VRDN-001 10 mg/kg
5 infusions of VRDN-001 3 mg/kg
Experimental group
Description:
5 infusions of VRDN-001 3 mg/kg
Treatment:
Drug: VRDN-001 3 mg/kg

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems