Thyroid Eye DiseasePhase 3Halo-2NCT07720648
A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye Disease
A Phase 3 study testing KHN939 in people with Thyroid Eye Disease, run by Beijing Kanghong Biological Medicine Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- KHN939
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- proptosis ≥18 mm, accompanied by at least one of the following: (a) eyelid retraction ≥2 mm; (b) moderate to severe soft tissue involvement; (c) intermittent or continuous diplopia
- CAS ≤ 2 points in each eye
- CAS ≤ 2 in each eye for 6 months prior to screening (based on medical records); or meets all of the following criteria for ≥ 6 months prior to screening (based on patient self-report or medical records): no progression of proptosis, no new-onset or progressive TED-related diplopia, no new-onset inflammatory TED symptoms
Show all 9Show fewer
- The time since initial TED diagnosis is ≥ 2 years and < 10 years prior to screening (documented by patient history or medical records)
- 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
Who cannot join
- 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 or investigator-assessed diagnosis of dysthyroid optic neuropathy (DON) at screening
- Corneal involvement in the study eye without improvement after appropriate treatment
- Prior orbital radiotherapy or surgery for TED in the study eye (including orbital decompression, strabismus correction, eyelid correction)
Show all 35Show fewer
- Requires immediate or planned ophthalmic surgical intervention during the study period
- Has any pre-existing ocular condition (e.g., high myopia, anticipated cataract surgery) that, as determined by the investigator, would preclude study participation or complicate the interpretation of study results
- Prior/concomitant treatments:
- Use of oral or intravenous glucocorticoids within 30 days prior to screening
- Periorbital/periocular corticosteroid injection within 90 days of screening
- Oral or IV non-steroidal immunosuppressants within 90 days of screening
- Corticosteroid or non-steroidal immunosuppressant eye drops within 7 days of screening
- Received teprotumumab or teprotumumab N01 at any time prior to screening
- Received anti-CD20 antibody therapy within 12 months prior to screening
- Received anti-interleukin-6 receptor (anti-IL-6R) antibody therapy within 6 months prior to screening
- Received any other investigational therapy for TED at any time prior to screening (including, but not limited to, biologics targeting IGF-1R, FcRn, or TSHR)
- Received any other monoclonal antibody therapy within 90 days prior to screening
- Need for selenium or vitamin supplementation for TED treatment from 21 days pre-dose through study end (multivitamins are permitted)
- Medical history/conditions:
- Medical conditions that contraindicate study drug use, including: suspected or confirmed inflammatory bowel disease (IBD), coagulopathy, Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 180 days, acute myocardial infarction (MI), unstable angina, or CABG/PCI within 180 days, severe arrhythmia, or severe systemic infection
- Malignancy (treated or untreated) within 5 years prior to screening, except for the following cured or non-metastatic conditions: cutaneous squamous cell carcinoma (SCC) or basal cell carcinoma (BCC), cervical or prostate carcinoma in situ (CIS), papillary thyroid carcinoma
- Uncontrolled diabetes (HbA1c ≥8.0% at screening, or initiation of a new diabetes medication, or a >10% dose adjustment to an existing diabetes medication within 60 days prior to screening)
- Poorly controlled thyroid function: defined as FT3 or FT4 deviating ≥50% from local laboratory normal range (≥1.5×ULN or ≤0.5×LLN)
- Uncontrolled hypertension: defined as SBP ≥160 mmHg or DBP ≥100 mmHg; renal artery stenosis; or other evidence of clinically unstable blood pressure
- 12-lead ECG with a heart rate <50 or >100 bpm and evidence of active cardiac disease; or any screening ECG abnormality that, in the investigator's opinion, confounds subsequent interpretation, particularly QTcF >450 ms in males or >470 ms in females
- Laboratory exclusions at screening:
- Alanine aminotransferase (ALT) >3 × ULN
- Aspartate aminotransferase (AST) >3 × ULN
- Serum creatinine(Cr) ≥1.5 × ULN, or glomerular filtration rate (GFR) <30 mL/min/1.73 m² (MDRD formula)
- 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
- Participation in any drug, vaccine, or device clinical trial within 3 months prior to screening, or currently within follow-up or within 5 half-lives of another study
- Female subjects who are pregnant or lactating
- Any other condition deemed by the investigator as inappropriate for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200135
Study Team, +86-028-87509966/87508866, khn939_trial@cnkh.com
About this study
Official title: A Multicenter, Randomized, Double-masked, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of KHN939 in the Treatment of Moderate-to-Severe Inactive Thyroid Eye Disease (TED) in China.
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.
- Conditions
- Thyroid Eye Disease
- Being tested
- KHN939, Placebo
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHN939Drug
Intravenous (IV) infusion: 20 mg/kg every 3 weeks (Q3W) for a total of 8 doses over 21 weeks
PlaceboDrug
Intravenous (IV) infusion: placebo every 3 weeks (Q3W) for a total of 8 doses over 21 weeks
| Study group | Role | What they receive |
|---|---|---|
| KHN939 20 mg/kg | Experimental | 8 infusions of KHN939 q3W for a total of 21 weeks Receives: Drug: KHN939 |
| Placebo | Placebo comparator | 8 infusions of placebo q3W for a total of 21 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proptosis responder rate of the study eye
Defined as percentage of subjects with a ≥ 2mm reduction from Baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye at Week 24. Proptosis assessment: amount of protrusion of the eye from the orbital rim measured by Hertel exophthalmometer.
Measured: Week 24
Secondary outcomes (13)
Proptosis responder rate in the study eye
See primary outcome measure description for details.
Measured: Week 12
Change from baseline in proptosis measurement of the study eye
See primary outcome measure description for details.
Measured: week 12, week 24
Change in Quality of Life (GO-QoL) Scores
The GO-QoL is a 16-item self-administered questionnaire divided into 2 subsets and used to assess the perceived effects of TED by the subjects on (i) their daily physical activity as it relates to visual function, and (ii) psychosocial functioning. The range of the GO-QoL overall transformed scores is 0 to 100, where higher values correspond to better quality of life.
Measured: week 12, week 24
Change from baseline in Clinical Activity Score (CAS) in the study eye
The CAS, based on the 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amendment, was used to evaluate clinical activity. The CAS ranges from 0 to 7, where higher scores indicate greater disease activity (worse outcome).
Measured: week 12, week 24
Change from baseline in diplopia score
Diplopia will be evaluated using the Gorman Subjective Diplopia Scale. The total score ranges from a minimum value of 0 to a maximum value of 3 (0 = no diplopia; 1 = intermittent diplopia; 2 = inconstant diplopia; 3 = constant diplopia). Higher scores mean a worse outcome (more severe diplopia condition).
Measured: week 12, week 24
Change from Baseline in Diplopia Questionnaire (DQ) Score
The Diplopia Questionnaire (DQ) will be used to evaluate the severity and impact of diplopia. Total scores range from 0 to 100, with higher scores indicating greater symptom severity and a more significant negative impact on daily life (representing a worse outcome).
Measured: Week 12, Week 24
Percentage of subjects with a CAS value of 0 or 1 in the study eye
Measured: week 12, week 24
Proptosis responder rate in the non-study eye
Measured: week 12, week 24
Change from baseline in proptosis measurement in the non-study eye
Measured: week 12, week 24
Change from baseline in ocular motility of the study eye
Measured: week 12, week 24
The number, incidence, severity, and relevance to study drugs or treatments of all ocular and other systemic AEs, TEAEs, AESIs, and SAEs
Measured: From the Screening period through study completion, with each participant completing all study visits over approximately 28 weeks, comprising a Screening Period (up to 4 weeks), a Treatment Period (21 weeks), and a Safety Follow-up Period (3 weeks).
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAbs)
Measured: Up to Week 24
Serum Drug Concentration
Serum drug concentrations will be collected at the following scheduled time points:
- Pre-dose (within 1 hour before infusion) and end-of-infusion (within 5 minutes after infusion completion) at Dose 1 (Week 0/Day 1), Dose 2 (Week 3), Dose 3 (Week 6), and Dose 5 (Week 12)
- A single sample at Week 1 (Day 8)
- A single sample at Week 24 or at early termination Serum concentration data from all sampling time points will be used to develop a population pharmacokinetic (PopPK) model and characterize the pharmacokinetics of KHN939.
Measured: Pre-dose and end-of-infusion at Doses 1, 2, 3, and 5, with additional samples at Week 1 and Week 24 (or early termination), up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Kanghong Biological Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720648
- Sponsor's protocol ID
- KHN939-60102
- Acronym
- Halo-2
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-masked, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of KHN939 in the Treatment of Moderate-to-Severe Inactive Thyroid Eye Disease (TED) in China.
- ClinicalTrials.gov ID
- NCT07720648
- Acronym / sponsor ID
- Halo-2 / KHN939-60102
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Beijing Kanghong Biological Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHN939 20 mg/kg | Experimental | Drug: KHN9398 infusions of KHN939 q3W for a total of 21 weeks |
| Placebo | Placebo comparator | Drug: Placebo8 infusions of placebo q3W for a total of 21 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (35 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHN939Intravenous (IV) infusion: 20 mg/kg every 3 weeks (Q3W) for a total of 8 doses over 21 weeks | Drug | KHN939 20 mg/kg |
| PlaceboIntravenous (IV) infusion: placebo every 3 weeks (Q3W) for a total of 8 doses over 21 weeks | Drug | Placebo |
Primary outcome
The proptosis responder rate of the study eye
Time frame: Week 24
Defined as percentage of subjects with a ≥ 2mm reduction from Baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye at Week 24. Proptosis assessment: amount of protrusion of the eye from the orbital rim measured by Hertel exophthalmometer.
13 secondary outcomes
Proptosis responder rate in the study eye
Time frame: Week 12
Change from baseline in proptosis measurement of the study eye
Time frame: week 12, week 24
Change in Quality of Life (GO-QoL) Scores
Time frame: week 12, week 24
Change from baseline in Clinical Activity Score (CAS) in the study eye
Time frame: week 12, week 24
Change from baseline in diplopia score
Time frame: week 12, week 24
Change from Baseline in Diplopia Questionnaire (DQ) Score
Time frame: Week 12, Week 24
Percentage of subjects with a CAS value of 0 or 1 in the study eye
Time frame: week 12, week 24
Proptosis responder rate in the non-study eye
Time frame: week 12, week 24
Change from baseline in proptosis measurement in the non-study eye
Time frame: week 12, week 24
Change from baseline in ocular motility of the study eye
Time frame: week 12, week 24
The number, incidence, severity, and relevance to study drugs or treatments of all ocular and other systemic AEs, TEAEs, AESIs, and SAEs
Time frame: From the Screening period through study completion, with each participant completing all study visits over approximately 28 weeks, comprising a Screening Period (up to 4 weeks), a Treatment Period (21 weeks), and a Safety Follow-up Period (3 weeks).
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAbs)
Time frame: Up to Week 24
Serum Drug Concentration
Time frame: Pre-dose and end-of-infusion at Doses 1, 2, 3, and 5, with additional samples at Week 1 and Week 24 (or early termination), up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Related trials for Thyroid Eye Disease
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Graves' Disease, Graves Disease
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KHN939 in people with Thyroid Eye Disease, run by Beijing Kanghong Biological Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhili Niu (+86-028-87516260, niuzhili@cnkh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proptosis responder rate of the study eye (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.