A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease
ConditionThyroid Eye Disease
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Teprotumumab N01
Biological/VaccineA total of 8 intravenous infusions of Teprotumumab N01 injection will be administered: 10 mg/kg on Day1, followed by 20 mg/kg in Week3-21, once every 3 weeks(Q3W).
Methylprednisolone
DrugA total of 12 intravenous infusions of methylprednisolone will be administered: 500 mg for the first six doses (on Day 1 and weekly throughout Weeks 1-5), and then 250 mg for the following six doses (weekly throughout Weeks 6-11). Based on disease deterioration and treatment response, participants will receive individualized treatment after IVGC therapy.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Intravenous glucocorticoid (IVGC) groupActive comparator 1 intervention
Group B: Teprotumumab N01 groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proptosis responder rate of the study eye
The proptosis response rate of the study eye was defined as the percentage of participants with a ≥ 2 mm reduction in proptosis of the study eye from baseline and without a ≥ 2 mm increase in proptosis of the fellow eye. Proptosis assessment: protrusion of the eye from the orbital rim as measured using a Hertel exophthalmometer.
Time frame
Week15Secondary outcomes
1
Change from baseline in proptosis of the study eye
Proptosis assessment: protrusion of the eye from the orbital rim as measured using a Hertel exophthalmometer.
Time frame
Weeks 15, 24 and 482
The overall response rate of the study eye
The overall response rate of the study eye was defined as the percentage of participants with a decrease in Clinical Activity Score \[CAS\] of ≥ 2 points from baseline in the study eye and a decrease in proptosis of ≥ 2 mm from baseline in the study eye, without deterioration in the fellow eye \[deterioration is defined as an increase in CAS of ≥ 2 points or an increase in proptosis of ≥ 2 mm\].
Time frame
Weeks 15, 24 and 483
Change from baseline in proptosis of the study eye on MRI imaging
Proptosis of the study eye as measured on orbital MRI imaging.
Time frame
Week154
The proptosis response rate of the study eye
The proptosis response rate of the study eye was defined as the percentage of participants with a ≥ 2 mm reduction in proptosis of the study eye from baseline and without a ≥ 2 mm increase in proptosis of the fellow eye.
Time frame
Weeks 24 and 48Sponsors and contacts
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Source ClinicalTrials.gov