A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease
ConditionThyroid Eye Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
This is a multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. The randomization stratification factor is diplopia at baseline (Gorman diplopia score ≥1 vs. Gorman diplopia score = 0).
Eligibility criteria
Qualifiers
Written informed consent.
Male or female subject between the ages of 18 and 80 years at screening.
Weight between 45 kg and 100 kg.
CAS ≥ 3 in the study eye at screening and baseline;
Disqualifiers
The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;
Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;
Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;
Scheduled orbital radiotherapy at any time before baseline or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;
Trial design
Treatments tested in this trial
- Teprotumumab N01
- Methylprednisolone
Treatment groups
92 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov