Trials / Recruiting
RecruitingNCT06989918
MHB018A Treatment in Patients With Active Thyroid Eye Disease
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Active Moderate-to-Severe Thyroid Eye Disease.
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- Sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MHB018A | MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W) |
| DRUG | MHB018A placebo | 6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w) |
Timeline
- Start date
- 2025-07-22
- Primary completion
- 2026-07-31
- Completion
- 2027-07-31
- First posted
- 2025-05-25
- Last updated
- 2026-04-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06989918. Inclusion in this directory is not an endorsement.