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The trial is taking place at:
F

Fraser Eye Care Center | Fraser, MI

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An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED) (REVEAL-1)

V

Viridian Therapeutics

Status and phase

Enrolling
Phase 3

Conditions

Thyroid Eye Disease

Treatments

Drug: VRDN-003
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06625411
VRDN-003-301

Details and patient eligibility

About

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active Thyroid Eye Disease (TED).

Full description

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with active TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as a series of subcutaneous/SC injections given every 4 weeks or every 8 weeks compared to placebo in participants with active TED.

Participants who do not have a meaningful response at Week 24 may be eligible to receive additional subcutaneous injections of VRDN-003.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 a Clinical Activity Score (CAS) of ≥ 4 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

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, 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 had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
  • Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
  • Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
  • Must not have a history of inflammatory bowel disease
  • Female TED participants who must not be pregnant or breastfeeding

NOTE: There are additional eligibility criteria for non-responders who may receive additional injections of VRDN-003. These are described in the protocol.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

84 participants in 3 patient groups, including a placebo group

VRDN-003 every 4 weeks
Experimental group
Description:
6 subcutaneous administrations of VRDN-003
Treatment:
Drug: VRDN-003
VRDN-003 every 8 weeks
Experimental group
Description:
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Treatment:
Drug: Placebo
Drug: VRDN-003
Placebo every 4 weeks
Placebo Comparator group
Description:
6 subcutaneous administrations of placebo
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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