Thyroid Eye DiseasePhase 2HAZEL 401NCT07438405
An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease
A Phase 2 study testing AMG 732 in people with Thyroid Eye Disease, run by Amgen at 8 sites in 4 countries.
Trial summary
The main objective of this trial is to assess the efficacy of AMG 732 in participants with thyroid eye disease (TED) who are defined as primary nonresponders or relapsed during the safety follow-up in the parent trial (NCT06401044). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- AMG 732
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 7 May 2026to 14 Jul 2028
- Phase
- Phase 2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Age ≥ 18 years at the time of signing informed consent for parent trial.
- Moderate-to-severe TED at the time of enrollment in parent trial and does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the rollover trial.
- Any worsening in thyroid status should be corrected to maintain euthyroid status for the entire rollover trial.
- Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.
- Participants with TED who completed Amgen-sponsored clinical trial of AMG 732.
Who cannot join
- Prior orbital irradiation or decompression in the study eye.
- Prior adult strabismus surgery.
- Use of any steroid (intravenous, oral, or injected) and steroid eye drops or other non-steroid immunosuppressive agent, monoclonal antibody except the trial drug in parent trial within a protocol-specified number of months prior to the first injection of study drug.
- Glycated hemoglobin (HbA1c) > 6.5% and/or fasting glucose levels> 126 mg/dL (> 7 mmol/L) at screening.
- Malignant condition in the past 5 years or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study.
- Active liver or kidney disfunction at screening.
Show all 13Show fewer
- Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening.
- Known hypersensitivity to teprotumumab, AMG 732 or any other monoclonal antibody products.
- Participants have had an adverse event that is considered related to AMG 732 which required study drug interruption/discontinuation in the parent study
- Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing.
- Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug.
- History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
United States4 sites, 4 recruiting
- Recruiting
Ilumina Medical Research
Kissimmee, Florida, 34744
- Recruiting
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
- Recruiting
Vision Medical Research, Inc.
Orland Park, Illinois, 60462
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Poland1 site, 1 recruiting
- Recruiting
Eb Group Spolka z ograniczona odpowiedzialnoscia
Warsaw, 00-189
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
About this study
Official title: An Open-label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-sponsored AMG 732 Studies and Are Primary Proptosis Non-responders or Who Relapsed During the Safety Follow-up
The main objective of this trial is to assess the efficacy of AMG 732 in participants with thyroid eye disease (TED) who are defined as primary nonresponders or relapsed during the safety follow-up in the parent trial (NCT06401044).
- Conditions
- Thyroid Eye Disease
- Being tested
- AMG 732
- Keywords
- Thyroid eye disease, AMG 732
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 732Drug
AMG 732 will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| AMG 732 | Experimental | Participants will receive AMG 732 subcutaneously (SC) Receives: Drug: AMG 732 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial
Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.
Measured: Week 24
Secondary outcomes (11)
Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial
Measured: Baseline and Week 24
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial
Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.
Measured: Week 24
Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial
Measured: Baseline and Week 24
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who were Defined as Primary Nonresponders in the Parent Trial
Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.
Measured: Week 24
Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who were Defined as Primary Nonresponders in the Parent Trial
Measured: Baseline and Week 24
Trough Concentration (Ctrough) of AMG 732
Measured: Baseline to Week 24
Maximum Observed Concentration (Cmax) of AMG 732
Measured: Baseline to Week 24
Time to Cmax (tmax) of AMG 732
Measured: Baseline to Week 24
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 732
Measured: Baseline to Week 24
Half-life (t1/2) of AMG 732
Measured: Baseline to Week 24
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESEAs), Adverse Events Leading to Investigational Product Discontinuation and Events of Interest (EOIs)
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start7 May 2026
- Primary completion29 Jan 2028 (estimated)
- Study completion14 Jul 2028 (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.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438405
- Sponsor's protocol ID
- 20230294
- Acronym
- HAZEL 401
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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
- An Open-label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-sponsored AMG 732 Studies and Are Primary Proptosis Non-responders or Who Relapsed During the Safety Follow-up
- ClinicalTrials.gov ID
- NCT07438405
- Acronym / sponsor ID
- HAZEL 401 / 20230294
- Conditions
- Thyroid Eye Disease
- Keywords
- Thyroid eye disease, AMG 732
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 29 Jan 2028 (estimated)
- Study completion
- 14 Jul 2028 (estimated)
- First posted
- 27 Feb 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.
The main objective of this trial is to assess the efficacy of AMG 732 in participants with thyroid eye disease (TED) who are defined as primary nonresponders or relapsed during the safety follow-up in the parent trial (NCT06401044).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMG 732 | Experimental | Drug: AMG 732Participants will receive AMG 732 subcutaneously (SC) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Age ≥ 18 years at the time of signing informed consent for parent trial.
- Moderate-to-severe TED at the time of enrollment in parent trial and does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the rollover trial.
- Any worsening in thyroid status should be corrected to maintain euthyroid status for the entire rollover trial.
- Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.
Key exclusion criteria (13 listed)
- Prior orbital irradiation or decompression in the study eye.
- Prior adult strabismus surgery.
- Use of any steroid (intravenous, oral, or injected) and steroid eye drops or other non-steroid immunosuppressive agent, monoclonal antibody except the trial drug in parent trial within a protocol-specified number of months prior to the first injection of study drug.
- Glycated hemoglobin (HbA1c) > 6.5% and/or fasting glucose levels> 126 mg/dL (> 7 mmol/L) at screening.
- Malignant condition in the past 5 years or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study.
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 |
|---|---|---|
| AMG 732AMG 732 will be administered SC. | Drug | AMG 732 |
Primary outcome
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial
Time frame: Week 24
Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.
11 secondary outcomes
Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial
Time frame: Baseline and Week 24
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial
Time frame: Week 24
Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial
Time frame: Baseline and Week 24
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who were Defined as Primary Nonresponders in the Parent Trial
Time frame: Week 24
Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who were Defined as Primary Nonresponders in the Parent Trial
Time frame: Baseline and Week 24
Trough Concentration (Ctrough) of AMG 732
Time frame: Baseline to Week 24
Maximum Observed Concentration (Cmax) of AMG 732
Time frame: Baseline to Week 24
Time to Cmax (tmax) of AMG 732
Time frame: Baseline to Week 24
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 732
Time frame: Baseline to Week 24
Half-life (t1/2) of AMG 732
Time frame: Baseline to Week 24
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESEAs), Adverse Events Leading to Investigational Product Discontinuation and Events of Interest (EOIs)
Time frame: Up to Week 48
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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 732 in people with Thyroid Eye Disease, run by Amgen at 8 sites in 4 countries.
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 6 inclusion and 13 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: looking for participants now, 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 8 sites in United States, Spain, Poland, Taiwan. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial (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.