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The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED.
The percentage of subjects with a reduction in proptosis of ≥2 mm in the study eye/target eye compared to baseline, without deterioration (≥2 mm) in the fellow eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MHB018A | Experimental | 6 subcutaneous injections of MHB018A, 450mg once every 4 weeks (q4w) |
|
| MHB018A Placebo | Placebo Comparator | 6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MHB018A | Drug | MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proptosis Responder Rate at Week 24 | The percentage of subjects with a reduction in proptosis of ≥2 mm in the study eye/target eye compared to baseline, without deterioration (≥2 mm) in the fellow eye. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Change in proptosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VP of R&D | Contact | 86 0571-86963293 | jwshi@minghuipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 201419 | China |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| MHB018A placebo |
| Drug |
6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w) |
|
Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 24 |
| Baseline, up to Week 24 |
| Percentage of subjects with CAS of 0 or 1 | The percentage of subjects with a CAS of 0 or 1 in the study eye/target eye. | Week 24 |
| Change in CAS | The mean change from baseline to Week 24 in the CAS in the study eye/target eye. | Week 24 |
| Diplopia response rate | The percentage of subjects with a reduction in diplopia severity by ≥1 grade. | Week 24 |
| Change in Quality of Life (GO-QOL) Scores | The mean change in scores from the Graves' Ophthalmopathy Quality of Life questionnaire compared to baseline. | Week 24 |
| Pharmacokinetic Parameter Trough Concentration for MHB018A | Trough concentration (Ctrough) will be assessed using non-compartmental methods in participants randomized to the MHB018A group. | Up to Week 24 |
| Anti-MHB018A antibody (ADA) incidence | The percentage of subjects developing anti-MHB018A antibodies. | Up to Week 24 and at end-of-trial (EOT) visit |
| 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 |