Health TrialsbyHealthPanel

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

ConditionThyroid Eye Disease (TED)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ZL-1109 (VRDN-003)

    Drug

    ZL-1109 subcutaneous injection

  • Placebo

    Drug

    Matching placebo subcutaneous injection

Treatment groups

99 Participants
are divided into 4 treatment groups
Group A: Randomized controlled period: ZL-1109 every 4 weeksExperimental treatment 1 intervention
Group B: Randomized controlled period: ZL-1109 every 8 weeksExperimental treatment 2 interventions
Group C: Randomized controlled period: Placebo every 4 weeksPlacebo comparator 1 intervention
Group D: OLE treatment period: ZL-1109 every 4 weeksOther 1 intervention

Trial outcomes

Primary outcomes

1

Proptosis Responder Rate in the study eye

Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]

Time frame
At Week 24

Secondary outcomes

1

Change from baseline in proptosis in the study eye

Change from baseline in proptosis in the study eye

Time frame
At Week 24
2

Overall Responder Rate in the study eye

Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]) AND ≥ 2 points reduction in CAS from baseline in the study eye \[without a corresponding increase of ≥2 points in the fellow eye\]

Time frame
At Week 24
3

Change from baseline in Clinical Activity Score (CAS) in the study eye

Change from baseline in CAS in the study eye \[range, 0 to 7, with higher scores indicating greater level of inflammation\]

Time frame
At Week 24
4

Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye

Proportion of participants with a CAS of 0 or 1 in the study eye

Time frame
At Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zai Lab (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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