MHB018A Treatment in Patients With Active Thyroid Eye Disease

NCT06989918 | Recruiting Phase 3

• 1 other identifier: MHB018A-P-301
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Associated Ophthalmopathies

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Overall response rate

  Week 24

• Change in proptosis

  Baseline, up to Week 24

• Percentage of subjects with CAS of 0 or 1

  Week 24

• Change in CAS

  Week 24

• Diplopia response rate

  Week 24

Study Arms (2)

MHB018A

EXPERIMENTAL

6 subcutaneous injections of MHB018A, 450mg once every 4 weeks (q4w)

Drug: MHB018A

MHB018A Placebo

PLACEBO COMPARATOR

6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)

Drug: MHB018A placebo

Interventions

MHB018A DRUG

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

MHB018A

MHB018A placebo DRUG

6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)

MHB018A Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily participating in the study and signing the informed consent form;
• Aged 18-75 years (inclusive), of any gender;
• Clinical diagnosis of active Thyriod Eye Disease (TED). The Clinical Activity Score (CAS) of the study eye/target eye at screening and baseline must be ≥3 points (7-point scale).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 201419, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

VP of R&D

CONTACT

86 0571-86963293; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 25, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)