AMG 732 for Thyroid Eye Disease | Graves' ophthalmopathy

Inclusion criteria

• {"criterion_text":"- Subject has provided informed consent before initiation of any study-specific activities/procedures.\n- Male or female aged 18 to 55 years for Part A and male or female aged 18 to 65 years for Part B 65 years for Part B, inclusive, at the time of informed consent.\n- Part B only: Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with 2 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and inconstant or constant diplopia.\n- Part B only: Subject had onset of active TED symptoms (as determined by subject records) within 15 months prior to baseline\n- Part B only: Clinical diagnosis of Graves disease associated with active TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye at screening and baseline\n- Part B only: Proptosis ≥ 18 mm in the study eye at baseline.\n- Part B Only: Subjects with baseline subjective binocular diplopia score > 0\n- Part B Only: Subjects must be euthyroid with the baseline disease under control or have mild hypo or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels < 50% below or above the normal limits) at screening. Every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of the trial.\n- Part B Only: Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial"}

Exclusion criteria

• {"criterion_text":"- Malignant condition in the past 12 months (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ)\n- The subject has a major surgery within 8 weeks prior to the first dose of study drug or plans to have an elective surgery from screening through end of study.\n- 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.\n- History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined in this section) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.\n- Part B only: Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, 9999) to the best of the subject and investigator’s knowledge, except when an eligible patient is contraindicated for 9999 in which case 9999 is not required. Also when subject did not consent for 9999 is not required.\n- Subjects with a history of 9999, such as 9999.\n- Laboratory Parameters for active liver disease, hepatic dysfunction or 9999 as determined by Part A: ALT or aspartate aminotransferase (AST) levels > 1.5 times upper limit of normal (ULN) Part B: ALT or AST levels > 3 times ULN or glomerular filtration rate ≤ 30 mL/min/1.73 m2 at screening. 9999\n- Positive test for hepatitis B serology at screening defined as: (1) positive for hepatitis B surface antigen (HBsAg); OR (2) positive for hepatitis B core antibody (HBcAb). Patients HBsAg negative, hepatitis B surface antibody (HBsAb) positive and HBcAb negative due to vaccination are eligible for the study. Patients HBsAg negative and HBsAb positive for which the cause cannot be determined as vaccination will be considered ineligible for the study\n- Positive test for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) antibody at screening or within the last 12 months. Subjects successfully treated for an HCV infection are allowed to participate if a sustained virologic response was achieved, defined as aviremia 24 weeks after completion of the antiviral therapy.\n- Subject tested positive for alcohol and/or drugs of abuse at screening\n- Part A: History of substance abuse (eg, alcohol, nicotine or tobacco, and licit or illicit drugs) within 12 months before screening. Part B only: History of substance abuse (eg, alcohol and illicit drugs) within 12 months before screening."}

Primary endpoints

• {"endpoint_text":"- Change from baseline at week 9999 in proptosis measurement by an exophthalmometer in the study eye","definition_or_measurement_approach":"Change from baseline at specified week (week 9999) measured by exophthalmometer in the study eye (proptosis measurement using an exophthalmometer)."}

Secondary endpoints

• {"endpoint_text":"- Subject incidence of treatment-emergent adverse events, including serious adverse events","definition_or_measurement_approach":"Incidence (count and proportion) of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported for subjects during the study."}
• {"endpoint_text":"- PK parameters including but not limited to maximum observed concentration (Cmax), time to maximum observed concentration (Tmax), area under the concentration time curve (AUC) over the dosing interval, accumulation following multiple dosing, and if feasible, half-life (t1/2) as data permits.","definition_or_measurement_approach":"Pharmacokinetic assessments measuring Cmax, Tmax, AUC over dosing interval, accumulation after multiple dosing, and half-life (t1/2) where data permit."}
• {"endpoint_text":"- Subject incidence of antidrug antibodies (ADAs)","definition_or_measurement_approach":"Immunogenicity testing to detect and report incidence of anti-drug antibodies (ADAs) in subjects."}
• {"endpoint_text":"- Proptosis response status in the study eye 9999 proptosis in the fellow eye) at week 9999","definition_or_measurement_approach":"Assessment of proptosis response status in the study eye (and reported reference to fellow eye) at the specified week (week 9999) based on proptosis measurements."}
• {"endpoint_text":"- Mean change from Baseline at Week 9999 in the GO-QoL Visual Functioning (VF) subscale score","definition_or_measurement_approach":"Mean change from baseline in the GO‑QoL Visual Functioning subscale score at the specified week (week 9999)."}
• {"endpoint_text":"- Mean change from Baseline at Week 9999 in the GO-QoL Appearance (A) subscale score","definition_or_measurement_approach":"Mean change from baseline in the GO‑QoL Appearance subscale score at the specified week (week 9999)."}

Methods

• Leapcure digital recruitment campaign (campaign copy, imagery, patient journey, pre-screener questionnaire) targeting subjects with Thyroid Eye Disease; country-specific materials indicated for Germany, Spain, Poland, France and others (documents named with country suffixes).
• Online advertising and outreach via platforms including Google and Reddit (privacy policy documents present) as part of digital recruitment materials.
• Patient-facing recruitment materials including summary letters, advocacy materials and pre-screener questionnaires for prospective participants.
• Site-level recruitment arrangements (K1 recruitment arrangements documents) and recruitment procedure documents for country-specific implementation (e.g., Germany recruitment arrangements, recruitment procedure v1.0).

Spain

Earliest CTIS Part Ii Submission Date

12-08-2025

Latest Decision Or Authorization Date

16-09-2025

Processing Time Days

35

Number Of Sites

3

Number Of Participants

2

Poland

Earliest CTIS Part Ii Submission Date

29-08-2025

Latest Decision Or Authorization Date

19-09-2025

Processing Time Days

21

Number Of Sites

4

Number Of Participants

2

France

Earliest CTIS Part Ii Submission Date

28-08-2025

Latest Decision Or Authorization Date

16-09-2025

Processing Time Days

19

Number Of Sites

4

Number Of Participants

2

Italy

Earliest CTIS Part Ii Submission Date

07-07-2025

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

107

Number Of Sites

4

Number Of Participants

8

Germany

Earliest CTIS Part Ii Submission Date

11-08-2025

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

275

Number Of Sites

5

Number Of Participants

3

Greece

Earliest CTIS Part Ii Submission Date

22-10-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

198

Number Of Sites

2

Number Of Participants

3

Primary sponsor

Full Name

Amgen Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Biologics Development Services LLC

Responsibilities

code: 4

Name

Bioclinica Inc.

Responsibilities

ECG, Tablet, MRI Central Reader

Name

Suvoda LLC

Responsibilities

code: 3

Name

Medical Equipment Supplies And Management Limited

Responsibilities

Equipment/exophthalmometer, refrigerator, scales, centrifuge, freezer, thermometer

Name

Q Squared Solutions LLC

Responsibilities

code: 4

Name

Labcorp Central Laboratory Services SARL

Responsibilities

code: 4

Third parties

• {"country":"United States","full_name":"Biologics Development Services LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ECG, Tablet, MRI Central Reader","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment/exophthalmometer, refrigerator, scales, centrifuge, freezer, thermometer","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}