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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Thyroid Eye Disease

In brief

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.

Key facts

Study ID

NCT06248619

Run by

Amgen

People needed

89

Starts

2024-07-05

Expected to finish

2026-11-13

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must provide written informed consent.
• Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening.
• 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.
• 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.)
• 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.
• Participant had onset of active TED symptoms (as determined by participant records) within 15 months prior to Baseline.
• 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.
• Participant does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.
• 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).
• Participant is willing and able to comply with the protocol requirements for the duration of the trial.

You may not qualify if…

• 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.
• Participant has corneal decompensation unresponsive to medical management.
• Participant has a decrease in CAS of ≥ 2 points between Screening and Baseline.
• Participant has a decrease in proptosis of ≥ 2 mm between Screening and Baseline.
• Participant had prior orbital irradiation, orbital decompression or strabismus surgery (excluding childhood strabismus surgeries unrelated to TED/Graves' disease).
• Participant is planning to have eyelid surgery during the trial.
• Participant received periocular botulinum toxin injection within 12 months prior to Screening.
• 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.

Where it is running

• 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
• 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 — Naples, Campania, Italy
• Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello — Pisa, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.