Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease
ConditionThyroid Eye Disease (TED)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinghui Pharmaceutical (Hangzhou) Ltd
About this trial
This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects voluntarily participating in the study and signing the informed consent form;
Aged 18-75 years (inclusive), of any gender;
Completed the 24-week double-blind treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, and within 28 days after Week 24 visit of the previous study when enrolled in this OLE study (does not apply to subjects who meet the relapse criteria during the safety follow-up period).
Proptosis non-responder at Week 24 visit in the double-blind treatment period of either the MHB018A-P-301 or MHB018A-P-302 study (defined as a <2 mm reduction from baseline in the study eye, or a ≥2 mm reduction in the study eye accompanied by a ≥2 mm worsening from baseline in proptosis of the fellow eye), and/or who meet the retreatment criteria for relapse during the safety follow-up period.
Disqualifiers
Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.
Corneal decompensation unresponsive to medical management.
Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
Received any treatment for TED, intravenous corticosteroids, immunosuppressive agents, investigational drug from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.
Trial design
Design model
Single group
Treatments tested in this trial
MHB018A injection
DrugMHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
Treatment groups
258 Participants
are divided into 1 treatment groupGroup A: MHB018A InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proptosis Responder Rate at Week 24
The proptosis response rate at Week 24 in the study eye for subjects with active or chronic TED who received MHB018A placebo in either the MHB018A-P-301 or MHB018A-P-302 studies: the proportion of subjects achieving a reduction of ≥2 mm in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) in the study eye, without deterioration in the other eye (defined as an increase in proptosis of ≥2 mm).
Time frame
Week 24Secondary outcomes
1
TED relapse rate
TED relapse rate from treatment discontinuation to relapse (for subjects with active or chronic TED who previously received and completed 24 weeks of MHB018A Injection treatment in either the MHB018A-P-301 or MHB018A-P-302 study, meet the disease relapse enrollment criteria for this study during the safety follow-up period, and receive retreatment with MHB018A Injection)
Time frame
From baseline up to Week 242
TED relapse time
TED relapse time from treatment discontinuation to relapse (for subjects with active or chronic TED who previously received and completed 24 weeks of MHB018A Injection treatment in either the MHB018A-P-301 or MHB018A-P-302 study, meet the disease relapse enrollment criteria for this study during the safety follow-up period, and receive retreatment with MHB018A Injection)
Time frame
Up to Week 24 and at end-of-trial (EOT) visit3
Overall response rate
The percentage of subjects with ≥2-points in Clinical Activity Score (CAS) reduction and ≥2 mm reduction in proptosis from baseline, provided there is no corresponding deterioration (≥2-points/mm increase) in CAS or proptosis in the fellow eye.
Time frame
Week 244
Change in proptosis
Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 24
Time frame
Baseline, up to Week 24Sponsors and contacts
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Source ClinicalTrials.gov