A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

NCT06401044 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 20230302
• Study Type: interventional
• Target: 88
• Locations: 11 countries
• Sites: 30

Brief Summary

The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.

Conditions

Thyroid Eye Disease

Keywords

AMG 732; Thyroid Eye Disease; TED

Outcome Measures

Primary Outcomes (2)

• Part A: Number of Participants With Treatment-emergent Adverse Events

  Day 1 through Week 36 (End of Study)

• Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye

  Baseline to End of Treatment (EoT) (approximately 6 Months)

Secondary Outcomes (15)

• Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732

  Up to Week 36

• Part A: Time to Cmax (Tmax) of AMG 732

  Up to Week 36

• Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732

  Up to Week 36

• Part A: Half-life (t1/2) of AMG 732

  Up to Week 36

• Part A: Number of Participants With Anti-drug Antibodies (ADAs)

  Up to Week 36

Study Arms (6)

Part A: AMG 732

EXPERIMENTAL

Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).

Drug: AMG 732

Part A: Placebo

PLACEBO COMPARATOR

Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).

Other: Placebo

Part B: AMG 732 Low Dose

EXPERIMENTAL

Participants will receive AMG 732 low dose SC.

Drug: AMG 732

Part B: AMG 732 Medium Dose

EXPERIMENTAL

Participants will receive AMG 732 medium dose SC.

Drug: AMG 732

Part B: AMG 732 High Dose

EXPERIMENTAL

Participants will receive AMG 732 high dose SC.

Drug: AMG 732

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC.

Other: Placebo

Interventions

AMG 732 DRUG

SC injection

Part A: AMG 732; Part B: AMG 732 High Dose; Part B: AMG 732 Low Dose; Part B: AMG 732 Medium Dose

Placebo OTHER

SC injection

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided informed consent before initiation of any study-specific activities/procedures.
• Male or female aged 18 to 55 years (Part A).
• Female participants must be of non-childbearing potential.
• Body mass index (BMI) between 18 and 30 kg/m\^2, inclusive, at screening.
• The participant has adequate venous access and can receive intravenous (IV) therapy.
• The participant is considered by the investigator or designee to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.
• Healthy Japanese participants in cohort 4 only. Japanese participants must meet all the following as confirmed by interview: Descendants of 4 ethnic Japanese grandparents who were born in Japan; Both parents are ethnic Japanese who were born in Japan; Hold a Japanese passport or identity papers; Have lived outside Japan for less than 10 years at the time of screening and lifestyle including diet has not changed significantly since leaving Japan.
• Male or female aged 18 to 65 years.
• Moderate-to-severe active TED.
• The participant had onset of active TED within 15 months prior to baseline.
• Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS)≥3 for the most severely affected eye at screening and baseline.
• Proptosis ≥18mm in the study eye at baseline.
• Participants with baseline subjective binocular diplopia score \>0.
• Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.

You may not qualify if:

• Malignant condition in the past 12 months 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.
• Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening.
• Glycated hemoglobin (HbA1c) \> 6.5% and/or fasting glucose levels\> 126 mg/dL (\> 7 mmol/L) at screening.
• Use of any steroid (IV, oral, steroid eye drops) within 3 weeks prior to the first dose. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat injection related reactions or short course of steroid for asthma control.
• Known hypersensitivity to teprotumumab or any other monoclonal antibody products.
• History of substance abuse within 12 months before screening.
• 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.
• Blood pressure or ECG abnormalities at screening.
• Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug.
• Use of teprotumumab or any other IGF-1R inhibitor.
• Prior orbital irradiation or decompression in the study eye.
• History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease).

Sponsors & Collaborators

• Amgen: lead

Study Sites (30)

Applied Research Center of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

RECRUITING

Ilumina Medical Research

Kissimmee, Florida, 34744, United States

RECRUITING

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

RECRUITING

Vision Medical Research, Inc.

Orland Park, Illinois, 60462, United States

RECRUITING

Ppd Las Vegas Research Unit

Las Vegas, Nevada, 89113, United States

RECRUITING

Erie Retina Research

Erie, Pennsylvania, 16505, United States

RECRUITING

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Macquarie University

North Ryde, New South Wales, 2109, Australia

RECRUITING

North Shore Private Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 0A6, Canada

RECRUITING

Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

Nantes, 44800, France

RECRUITING

Hopital Pitie-Salpetriere

Paris, 75013, France

RECRUITING

Universitaetsklinikum Essen

Essen, 45147, Germany

RECRUITING

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, 480-1195, Japan

RECRUITING

Hayashi Eye Hospital

Fukuoka, Fukuoka, 812-0011, Japan

RECRUITING

Kozawa Eye Hospital And Diabetes Center

Mito, Ibaraki, 310-0845, Japan

RECRUITING

Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

Gdansk, 80-180, Poland

RECRUITING

Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa

Swidnica, 58-100, Poland

RECRUITING

Eb Group Spolka z ograniczona odpowiedzialnoscia

Warsaw, 00-189, Poland

RECRUITING

Singapore National Eye Centre

Singapore, 169608, Singapore

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): February 22, 2027
• Study Completion (Estimated): August 13, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

DE (1); FR (2); ES (3); PL (3); SG (1); TW (2); US (9); CA (1); JP (3); IT (3); AU (2)