Treatment of Chronic Thyroid Eye Disease With MHB018A

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Minghui Pharmaceutical (Hangzhou) Ltd
Study ID
NCT07622121
Phase
PHASE3
Status
Recruiting

Conditions

  • Thyroid Eye Disease, TED

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.

Key Dates

First listed
Jun 2, 2026
Start date
Sep 24, 2026
Status verified
Oct 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MHB018A Injection
    subcutaneous injections of MHB018A injection, 450mg once every 4 weeks (q4w).
  • Placebo Comparator: MHB018A Injection Placebo
    subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)

Primary Outcome Measure

Proptosis response rate at Week 24 [ Time Frame: Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hype Clinical ResearchCoral GablesFlorida33134
Hype Clinical Research
(786) 471-1922

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