Teprotumumab for Thyroid Eye Disease

Recruiting at 45 trial locations

Overseen By Horizon Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Amgen

Disqualifiers: Immediate surgery, Diabetes, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

313 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the safety and effectiveness of teprotumumab, an IV medication, in adults with Thyroid Eye Disease. It aims to find the best treatment period and assess the need for additional treatment. The medication helps by reducing inflammation and tissue changes in the eyes. Teprotumumab, initially developed for tumor treatment, was later repurposed for thyroid eye disease and approved by the USFDA.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

Adults aged 18-80 with Thyroid Eye Disease (TED) diagnosed within the last 7 years, not needing immediate eye surgery. Women must test negative for pregnancy and use reliable contraception. Diabetics with HbA1c ≤8% are eligible if they have controlled thyroid levels or mild thyroid dysfunction.

Inclusion Criteria

My eye bulging has increased by 3 mm or more since my TED diagnosis.

I was diagnosed with TED within the last 7 years.

My thyroid function is normal or slightly off but under control.

Exclusion Criteria

You are allergic to teprotumumab or have had allergic reactions to similar medications in the past.

You have untreated HIV, or positive viral load for hepatitis C or hepatitis B infections.

I have had radiation, surgery to relieve eye pressure, or eye muscle surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Initial Treatment

Participants receive teprotumumab infusions based on cohort assignment: 4, 8, or 16 infusions

24-48 weeks

Infusions every 3 weeks

End-of-Initial Treatment

Comprehensive assessment of treatment response at the end of the initial treatment period

1 week

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness; proptosis responders and non-responders are assessed for re-treatment eligibility

52 weeks

Re-treatment (if applicable)

Eligible participants receive a second course of teprotumumab infusions if they flare during follow-up

24 weeks

Infusions every 3 weeks

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness

Up to Week 136

Treatment Details

Interventions

• Teprotumumab

Trial Overview The trial tests Teprotumumab's safety and effectiveness in treating TED compared to a placebo. It involves three different treatment durations, random assignment of participants to groups, double-masking, and parallel assignment across multiple centers.

Participant Groups

Group I: Teprotumumab 8 Infusions Experimental Treatment 1 Intervention

8 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 7 infusions) (Cohort 2)

Group II: Teprotumumab 4 Infusions Experimental Treatment 2 Interventions

• 4 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 3 infusions) (Cohort 1) followed by 4 infusions of: * Placebo if a participant is a treatment responder at Week 12 or * Teprotumumab 20 mg/kg if a participant is a treatment non-responder at Week 12

Group III: Teprotumumab 16 Infusions Experimental Treatment 1 Intervention

16 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 15 infusions) (Cohort 3)

Teprotumumab is already approved in United States for the following indications:

Approved in United States as Tepezza for:

• Thyroid Eye Disease

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Horizon Therapeutics USA, Inc.

Lead Sponsor

Trials

4

Recruited

420+