Open-Label Extension Study of MHB018A in Patients With Thyroid Eye Disease

Официальное название

A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease

Обзор

This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.

Подробное описание

The primary objective of this study is to evaluate the improvement in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) following treatment with MHB018A Injection in subjects with active or chronic TED who previously received placebo in either the MHB018A-P-304 or MHB018A-P-305 studies, and the safety and tolerability of MHB018A Injection in TED subjects.

Вмешательства

• Препарат MHB018A injection
  MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)

Первичные конечные точки

• Proptosis Responder Rate at Week 24 [Срок оценки: Week 24]

Вторичные конечные точки (10)

• TED relapse rate [Срок оценки: From baseline up to Week 24]
• TED relapse time [Срок оценки: Up to Week 24 and at end-of-trial (EOT) visit]
• Overall response rate [Срок оценки: Week 24]
• Change in proptosis [Срок оценки: Baseline, up to Week 24]
• Percentage of subjects with CAS of 0 or 1 [Срок оценки: Week 24]
• Change in CAS [Срок оценки: Week 24]
• Diplopia response rate [Срок оценки: Week 24]
• Change in Quality of Life (GO-QOL) Scores [Срок оценки: Up tp Week 24]
• Pharmacokinetic Parameter Trough Concentration for MHB018A [Срок оценки: Up tp Week 24]
• Incidence of Adverse Events (AEs) During Treatment [Срок оценки: Up to Week 24 and at end-of-trial (EOT) visit]

Критерии участия

Критерии включения

• 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.
• Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
• Diabetic subjects must have well-controlled stable disease.
• Sufficient bone marrow and organ function.
• Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.
• Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.

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Критерии исключения

• 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.
• Identified pre-existing ophthalmic disease that would preclude study participation or complicate interpretation of the study results.
• Acute cardiovascular disease history or treatment within 6 months before the first dose from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.
• Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
• Pregnant or lactating women.
• Tinnitus or other hearing impairment.
• Poor compliance or severe systemic disease history or other reasons that make the subject unsuitable for participation in this clinical study.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07620405 · MHB018A-P-306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗