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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZai Lab (Shanghai) Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ZL-1109 (VRDN-003)
  • Placebo

Treatment groups

99 Participants
are divided into 4 treatment groups

Sponsors and collaborators