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Recruiting
Sponsor ID
20230294

An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye DiseaseHAZEL 401

Sponsor ID
20230294
Clinicaltrials.gov ID
NCT07438405
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 2
Product
AMG 732
Type
Interventional
Masking
None (Open Label)
Enrollment
30
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Week 24

Secondary Outcome Measures

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Baseline and Week 24

Trough Concentration (Ctrough) of AMG 732

Timeframe: Baseline to Week 24

Maximum Observed Concentration (Cmax) of AMG 732

Timeframe: Baseline to Week 24

Time to Cmax (tmax) of AMG 732

Timeframe: Baseline to Week 24

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 732

Timeframe: Baseline to Week 24

Half-life (t1/2) of AMG 732

Timeframe: 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)

Timeframe: Up to Week 48

Locations

Location
Status
Contact Us
Location
Applied Research Center of Arkansas
Little Rock, AR, United States, 72205
Status
Recruiting
Location
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 10002
Status
Recruiting
Location
Hospital Universitario Virgen Macarena
Sevilla, Andalucía, Spain, 41009
Status
Recruiting
Location
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Status
Recruiting
Location
Eb Group Spolka z ograniczona odpowiedzialnoscia
Warszawa, Poland, 00-189
Status
Recruiting
Location
Ilumina Medical Research
Kissimmee, FL, United States, 34744
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Thyroid Eye Disease (TED)
    • Sex
    All
    Trial Dates
    May 2026 - Jan 2028
    Inclusion and Exclusion Criteria
    Inclusion Criteria 1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Age ≥ 18 years at the time of signing informed consent for parent trial. 3. 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. 4. Any worsening in thyroid status should be corrected to maintain euthyroid status for the entire rollover trial. 5. Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention. 6. Participants with TED who completed Amgen-sponsored clinical trial of AMG 732. Exclusion Criteria 1. Prior orbital irradiation or decompression in the study eye. 2. Prior adult strabismus surgery. 3. 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. 4. Glycated hemoglobin (HbA1c) > 6.5% and/or fasting glucose levels> 126 mg/dL (> 7 mmol/L) at screening. 5. 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. 6. Active liver or kidney disfunction at screening. 7. Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening. 8. Known hypersensitivity to teprotumumab, AMG 732 or any other monoclonal antibody products. 9. Participants have had an adverse event that is considered related to AMG 732 which required study drug interruption/discontinuation in the parent study 10. 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. 11. Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug. 12. History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease). 13. Other protocol-defined inclusion/exclusion criteria apply.