A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye Disease (NCT07720648) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye Disease
China117 participantsStarted 2026-08
Plain-language summary
This is a multicenter, randomized, double-masked, placebo-controlled Phase 3 study to evaluate the efficacy, safety, immunogenicity, and population pharmacokinetic (PopPK) characteristics of KHN939 in Chinese patients with moderate-to-severe inactive thyroid eye disease (TED). Approximately 117 participants who meet the study eligibility criteria will be randomized in a 2:1 ratio (stratified by smoking status) to receive 8 infusions of KHN939 or placebo q3W.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18-70 years (inclusive) at the time of signing the informed consent form (ICF), male or female
. Weight between 45 kg and 100 kg (inclusive)
. Diagnosed with moderate-to-severe inactive TED:
. Female participants of childbearing potential must have a negative serum pregnancy test during screening and agree to use an effective method of contraception from screening until 90 days after the last dose of the study drug. (Note: Women of non-childbearing potential, defined as surgically sterile or postmenopausal, are exempt.)Male participants must agree to use birth control from screening until at least 90 days after the dose of study drug.
. Able to comply with all protocol-required procedures, examinations, and symptom reporting
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proptosis responder rate of the study eye
Timeframe: Week 24
Trial details
NCT IDNCT07720648
SponsorBeijing Kanghong Biological Medicine Co., Ltd.
. Known hypersensitivity to any component of the study drug formulation, or prior hypersensitivity to any monoclonal antibodies
. Proptosis at Day 1 (pre-dose) that has decreased by ≥2 mm relative to screening
. Ocular conditions:
. Prior/concomitant treatments:
. Medical history/conditions:
. Laboratory exclusions at screening:
. Clinically significant ear disease, prior ear surgery, hearing impairment, or abnormal pure-tone audiometry (defined as a mean bone conduction threshold ≥25 dB at 0.5, 1, 2, 4 kHz, or ≥40 dB at any frequency)
. Positive for HBsAg with HBV-DNA \>1000 IU/mL or currently receiving anti-HBV therapy; positive for HIV antibody or HCV antibody; or active syphilis