Menu
Recruiting NCT07211776

A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease

Phase III Interventional Thyroid Eye Disease (TED)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZL-1109 (VRDN-003), Placebo.
Who it may be relevant to
Registry conditions: Thyroid Eye Disease (TED). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Double-blinded, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ZL-1109 in Chinese Participants With Thyroid Eye Disease (TED)

Overview

A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)

Detailed description

This is a multicenter, Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of ZL-1109 in participants with active TED. The study will comprise a screening period of up to 28 days, a double-blinded randomized placebo-controlled period of 24 weeks and an extension period. For responders and non-responders who do not want to receive open-label treatment, the study period is 52 weeks from the first dose. For non-responders who consent to and are considered eligible to receive open-label treatment, the study period is 70 weeks from the first dose.

Interventions

  • Drug ZL-1109 (VRDN-003)
    ZL-1109 subcutaneous injection
  • Drug Placebo
    Matching placebo subcutaneous injection

Primary outcome measures

  • Proptosis Responder Rate in the study eye [Time frame: At Week 24]
Secondary outcome measures (7)
  • Change from baseline in proptosis in the study eye [Time frame: At Week 24]
  • Overall Responder Rate in the study eye [Time frame: At Week 24]
  • Change from baseline in Clinical Activity Score (CAS) in the study eye [Time frame: At Week 24]
  • Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye [Time frame: At Week 24]
  • Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0 [Time frame: At Week 24]
  • Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0 [Time frame: At Week 24]
  • Clinical Activity Responder Rate in the study eye [Time frame: At Week 24]

Eligibility criteria

Inclusion criteria

  • Have moderate to severe TED
  • Must meet the clinical diagnosis criteria of active TED
  • 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

  • Have received prior treatment with another anti-IGF-1R mAb or anti-thyroid stimulating hormone receptor (TSHR) mAb.
  • Have received systemic corticosteroids or steroid eye drops for any condition, or other immunosuppressive drugs for any condition, including TED, or radioactive iodine (RAI) treatment within a certain period prior to first dose.
  • Have corneal decompensation in the study eye unresponsive to medical management.
  • Have a pre-existing ophthalmic in the study eye which in the opinion of the Investigator, would confound interpretation of the study results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 27 centers
  • Site01006 — Beijing
  • Site01009 — Beijing
  • Site01010 — Beijing
  • Site01029 — Bengbu
  • Site01020 — Changsha
  • Site01022 — Chengdu
  • Site01031 — Chongqing
  • Site01011 — Dalian
  • … and 19 more centers

Identifiers

NCT: NCT07211776 · ZL-1109-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗