MHB018A Treatment in Patients With Chronic Thyroid Eye Disease

Официальное название

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease.

Обзор

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 chronic TED.

Подробное описание

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 chronic TED.

Вмешательства

• Препарат MHB018A injection
  MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
• Препарат MHB018A injection Placebo
  6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)

Первичные конечные точки

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

Вторичные конечные точки (9)

• 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: Week 24]
• Pharmacokinetic Parameter Trough Concentration for MHB018A [Срок оценки: Up to Week 24]
• Anti-MHB018A antibody (ADA) incidence [Срок оценки: Up to Week 24 and at end-of-trial (EOT) visit]
• 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;
• Clinical diagnosis of chronic Thyroid Eye Disease (TED) , with symptoms in the study eye more than 12 months and less than 10 years.
• Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.
• 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.
• Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.
• Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
• Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.
• Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops/ointments for TED within 4 weeks before the first dose; subjects who received periorbital/orbital steroid injections within 3 months before the first dose.
• Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).
• Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.
• Previous treatment targeting IGF-1R.
• Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and/or biotin is allowed.
• Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.
• Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.
• Malignant condition in the past 5 years before signing the ICF (except successfully treated basal/squamous cell carcinoma of the skin).
• Acute cardiovascular disease history or treatment within 6 months before the first dose.
• Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
• Pregnant or lactating women.
• Drug or alcohol abuse during the screening period.
• Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.
• Biopsy-proven or clinically suspected inflammatory bowel disease.
• Positive results for serum virology tests (defined as pos
• Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.
• Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study.
• Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07257185 · MHB018A-P-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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