Thyroid Eye Disease (TED)
Conditions
Keywords
Thyroid Eye Disease (TED)
Brief summary
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
DRUGZL-1109 (VRDN-003)
ZL-1109 subcutaneous injection
DRUGPlacebo
Matching placebo subcutaneous injection
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, Investigator, Outcomes Assessor and Sponsor will be masked.
Intervention model description
Participants will be randomized to one of the three study arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Have moderate to severe TED 2. Must meet the clinical diagnosis criteria of active TED 3. Must agree to use highly effective contraception as specified in the protocol 4. Female TED participants must have a negative serum pregnancy test at screening Key
Exclusion criteria
1. Have received prior treatment with another anti-IGF-1R mAb or anti-thyroid stimulating hormone receptor (TSHR) mAb. 2. 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. 3. Have corneal decompensation in the study eye unresponsive to medical management. 4. Have a pre-existing ophthalmic in the study eye which in the opinion of the Investigator, would confound interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proptosis Responder Rate in the study eye | At Week 24 | Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in proptosis in the study eye | At Week 24 | Change from baseline in proptosis in the study eye |
| Overall Responder Rate in the study eye | At Week 24 | 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 \[without a corresponding increase of ≥2 points in the fellow eye\] |
| Change from baseline in Clinical Activity Score (CAS) in the study eye | At Week 24 | Change from baseline in CAS in the study eye \[range, 0 to 7, with higher scores indicating greater level of inflammation\] |
| Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye | At Week 24 | Proportion of participants with a CAS of 0 or 1 in the study eye |
| Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0 | At Week 24 | Proportion of participants with a reduction in Diplopia Score of ≥1 from baseline (for participants with baseline Diplopia Score greater than 0) |
| Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0 | At Week 24 | Proportion of participants with a reduction in Diplopia Score to 0 from baseline (for participants with baseline Diplopia Score greater than 0) |
| Clinical Activity Responder Rate in the study eye | At Week 24 | Clinical Activity Responder Rate in the study eye (i.e., ≥ 2 points reduction in CAS from baseline in the study eye \[without a corresponding increase of ≥2 points in the fellow eye\]) |
Countries
China
Outcome results
None listed