NCT07257185
Not yet recruiting
Phase 3
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.
Minghui Pharmaceutical (Hangzhou) Ltd1 site in 1 country150 target enrollmentStarted: December 1, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Proptosis Responder Rate at Week 24
Overview
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 chronic TED.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
MHB018A Injection
Experimental
subcutaneous injections of MHB018A injection, 450mg once every 4 weeks (q4w).
Intervention: MHB018A injection (Drug)
MHB018A Injection Placebo
Placebo Comparator
subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)
Intervention: MHB018A injection Placebo (Drug)
Outcomes
Primary Outcomes
Proptosis Responder Rate at Week 24
Time Frame: 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.
Secondary Outcomes
- Overall response rate(Week 24)
- Incidence of Adverse Events (AEs) During Treatment(Up to Week 24 and at end-of-trial (EOT) visit)
- Change in proptosis(Baseline, up to Week 24)
- Pharmacokinetic Parameter Trough Concentration for MHB018A(Up to Week 24)
- Percentage of subjects with CAS of 0 or 1(Week 24)
- Anti-MHB018A antibody (ADA) incidence(Up to Week 24 and at end-of-trial (EOT) visit)
- Change in CAS(Week 24)
- Change in Quality of Life (GO-QOL) Scores(Week 24)
- Diplopia response rate(Week 24)
Investigators
Study Sites (1)
Loading locations...
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