A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

NCT ID: NCT06248619

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-05
• Study Completion Date: 2026-09-29

Brief Summary

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

Detailed Description

The main objective of the study is to evaluate the effect of teprotumumab subcutaneous administration versus placebo on the proptosis responder rate (ie, the percentage of participants with a ≥ 2-mm reduction from Baseline in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye) at Week 24.

Acquired from Horizon in 2024.

Conditions

Thyroid Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Teprotumumab

Teprotumumab administered SC

Group Type: EXPERIMENTAL

Teprotumumab

Intervention Type: BIOLOGICAL

SC injection

Placebo

Placebo for teprotumumab administered SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

SC injection

Interventions

Teprotumumab

SC injection

Intervention Type: BIOLOGICAL

Placebo

SC injection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participant must provide written informed consent.

2. Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening.

3. Participant must have a 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.

4. Participant must have moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement and/or inconstant or constant diplopia. (Note: Participants with no diplopia at Baseline will be limited to approximately 25% of the total number enrolled.)

5. Participant has proptosis ≥ 3 mm from Baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis ≥ 3 mm above normal for race and gender.

6. Participant had onset of active TED symptoms (as determined by participant records) within 15 months prior to Baseline.

7. Participants must be euthyroid with the baseline disease under control or have mild hypoor hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine [FT3] levels < 50% above or below 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.

8. Participant does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.

9. Women of childbearing potential must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (ie, prior to each dose and throughout participation in the trial).

10. Participant is willing and able to comply with the protocol requirements for the duration of the trial.

Exclusion Criteria

1. Participant has decreased best-corrected visual acuity due to optic neuropathy, defined by a decrease in vision of 2 lines on the Snellen chart (or equivalent), new visual field defect or color defect secondary to optic nerve involvement within the last 6 months.

2. Participant has corneal decompensation unresponsive to medical management.

3. Participant has a decrease in CAS of ≥ 2 points between Screening and Baseline.

4. Participant has a decrease in proptosis of ≥ 2 mm between Screening and Baseline.

5. Participant had prior orbital irradiation, orbital decompression or strabismus surgery (excluding childhood strabismus surgeries unrelated to TED/Graves' disease).

6. Participant is planning to have eyelid surgery during the trial.

7. Participant received periocular botulinum toxin injection within 12 months prior to Screening.

8. Participant has any systemic use of a steroid (IV or oral) or steroid eye drops for the treatment of TED or other conditions within 3 weeks prior to Screening. Exceptions include local administration (excluding periocular), eg, topical, intra-articular, and inhaled steroids, as well as steroids used to treat infusion reactions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Catalina Eye Care - NVISION - PPDS

Tucson, Arizona, United States

Advanced Quality Medical Research

Orland Park, Illinois, United States

W Kellogg Eye Center

Ann Arbor, Michigan, United States

Las Vegas Endocrinology

Henderson, Nevada, United States

The Center for Eye and Facial Plastic Surgery

Somerset, New Jersey, United States

Casey Eye Institute -515 SW Campus Dr

Portland, Oregon, United States

Scheie Eye Institute

Philadelphia, Pennsylvania, United States

University of Tennessee Health Science Center - 848 Adams Ave

Memphis, Tennessee, United States

Baylor College of Medicine-1977 Butler Blvd

Houston, Texas, United States

University of Washington Eye Institute

Seattle, Washington, United States

West Virginia University Eye Institute

Morgantown, West Virginia, United States

Centro de Ojos Loria

Lomas de Zamora, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Organización Médica de Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Centro Medico Grupo Laser Vision

Rosario, Santa Fe Province, Argentina

Sydney Eye Hospital

Sydney, New South Wales, Australia

Queensland Eye Institute

Wooloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaie, South Australia, Australia

Centre For Eye Research Australia Ltd

East Melbourne, Victoria, Australia

Vancouver Coastal Health Research Institute (VCHRI) - 2550 Willow St

Vancouver, British Columbia, Canada

McGill University Health Centre Research Institute

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval CUO Recherche Clinique Hopital du St-Sacrement

Québec, , Canada

AP-HM-Hôpital de La Conception

Marseille, Bouches-du-Rhône, France

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Azienda Ospedaliera Universitaria Federico II

Napoli, Campania, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

Pisa, , Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, , Italy

Hayashi Eye Hospital

Fukuoka, Hukuoka, Japan

Kozawa Eye hospital and Diabetes Center

Mito, Ibaraki, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Gokeikai Osaka Kaisei Hospital

Osaka-Shi Yodogawa-Ku, Ôsaka, Japan

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitari i Politecnic La Fe de Valencia-Avda de Fernando Abril Martorell 106

Valencia, , Spain

Changhua Christian Hospital

Changhua County, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Moorfields Eye Hospital - PPDS

London, Middlesex, United Kingdom

Countries

United States; Argentina; Australia; Canada; France; Germany; Italy; Japan; Spain; Taiwan; United Kingdom

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

HZNP-TEP-305

Identifier Type: -

Identifier Source: org_study_id