Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized controlled period: ZL-1109 every 4 weeks | Experimental | Participants will receive ZL-1109 per protocol defined dosing regimen. |
|
| Randomized controlled period: ZL-1109 every 8 weeks | Experimental | Participants will receive ZL-1109 and placebo per protocol defined dosing regimen. |
|
| Randomized controlled period: Placebo every 4 weeks | Placebo Comparator | Participants will receive placebo per protocol defined dosing regimen. |
|
| OLE treatment period: ZL-1109 every 4 weeks | Other | Participants who not responded would receive ZL-1109 per protocol defined dosing regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-1109 (VRDN-003) | Drug | ZL-1109 subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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] | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in proptosis in the study eye | Change from baseline in proptosis in the study eye | At Week 24 |
| 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] |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZL-1109-002 Study Team | Contact | 86 021-61632588 | 1109-002_studyteam@zailaboratory.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site01006 | Not yet recruiting | Beijing | China | |||
| Site01009 |
The study team does not plan to make individual participant data underlying the published results publicly available. This decision is based on two key considerations: (1) the absence of informed consent at the participant level for reuse of data beyond the pre-specified analyses outlined in the study protocol; (2) applicable privacy regulations in relevant jurisdictions which restrict the further dissemination of personally identifiable information. Aggregate-level data supporting the primary findings of the study will be made available through supplementary materials accompanying the publication, and may also be shared upon reasonable request to the corresponding author for purposes such as meta-analysis or regulatory review, provided that a formal data use agreement is executed.
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be randomized to one of the three study arms.
Not provided
Not provided
Participants, Investigator, Outcomes Assessor and Sponsor will be masked.
| Placebo | Drug | Matching placebo subcutaneous injection |
|
| At Week 24 |
| 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] | At Week 24 |
| 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 | At Week 24 |
| Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0 | Proportion of participants with a reduction in Diplopia Score of ≥1 from baseline (for participants with baseline Diplopia Score greater than 0) | At Week 24 |
| Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0 | Proportion of participants with a reduction in Diplopia Score to 0 from baseline (for participants with baseline Diplopia Score greater than 0) | At Week 24 |
| Clinical Activity Responder Rate in the study eye | Clinical Activity Responder Rate in the study eye (i.e., ≥ 2 points reduction in CAS from baseline in the study eye [without a corresponding increase of ≥2 points in the fellow eye]) | At Week 24 |
| Recruiting |
| Beijing |
| China |
| Site01010 | Not yet recruiting | Beijing | China |
| Site01029 | Not yet recruiting | Bengbu | China |
| Site01020 | Not yet recruiting | Changsha | China |
| Site01022 | Not yet recruiting | Chengdu | China |
| Site01031 | Recruiting | Chongqing | China |
| Site01011 | Not yet recruiting | Dalian | China |
| Site01008 | Recruiting | Foshan | China |
| Site01004 | Recruiting | Fuzhou | China |
| Site01007 | Recruiting | Guangzhou | China |
| Site01027 | Recruiting | Guiyang | China |
| Site01018 | Not yet recruiting | Hangzhou | China |
| Site01002 | Recruiting | Hefei | China |
| Site01024 | Recruiting | Jinan | China |
| Site01005 | Recruiting | Luoyang | China |
| Site01017 | Not yet recruiting | Nanchang | China |
| Site01001 | Recruiting | Shanghai | China |
| Site01012 | Not yet recruiting | Shenyang | China |
| Site01023 | Not yet recruiting | Taiyuan | China |
| Site01013 | Not yet recruiting | Tianjin | China |
| Site01016 | Not yet recruiting | Wuxi | China |
| Site01028 | Not yet recruiting | Xi'an | China |
| Site01025 | Not yet recruiting | Xuzhou | China |
| Site01026 | Not yet recruiting | Yangzhou | China |
| Site01019 | Not yet recruiting | Zhengzhou | China |
| Site01030 | Not yet recruiting | Zhengzhou | China |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided