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Monoclonal Antibodies

Teprotumumab for Graves' Eye Disease

Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial involves testing a new treatment for proptosis in a blinded study where some participants will receive the treatment and others will receive a placebo. Participants who do not respond to the initial treatment may have

Who is the study for?
Adults aged 18-80 with moderate-to-severe active Thyroid Eye Disease (TED) linked to Graves' disease can join. They should have had TED symptoms start within the last 15 months, not need immediate eye surgery, and be able to follow trial procedures. Women must test negative for pregnancy.
What is being tested?
The trial is testing Teprotumumab against a placebo in adults with active TED. Participants are randomly assigned to receive either the drug or placebo, without knowing which one they get, in a controlled environment across multiple centers.
What are the potential side effects?
Potential side effects of Teprotumumab may include muscle spasms, nausea, hair loss, diarrhea, fatigue, high blood sugar levels among others. The experience of side effects varies from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 3 trial • 83 Patients • NCT03298867
34%
Muscle Spasms
24%
Alopecia
15%
Nausea
12%
Diarrhoea
12%
Fatigue
12%
Dry Skin
10%
Headache
10%
Dysgeusia
10%
Amenorrhoea
7%
Stomatitis
7%
Dizziness
7%
Madarosis
5%
Cough
5%
Abdominal Pain Upper
2%
Infusion related reaction
2%
Influenza
2%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Teprotumumab 20 mg/kg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TeprotumumabExperimental Treatment1 Intervention
Teprotumumab administered SC
Group II: PlaceboPlacebo Group1 Intervention
Placebo for teprotumumab administered SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Teprotumumab
2023
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,434 Previous Clinical Trials
1,395,756 Total Patients Enrolled
Horizon Pharma USA, Inc.Lead Sponsor
22 Previous Clinical Trials
1,971 Total Patients Enrolled
MDStudy DirectorAmgen
972 Previous Clinical Trials
939,928 Total Patients Enrolled
~53 spots leftby Oct 2025
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