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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 baseline, week 24
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial tests TEPEZZA®, an IV medication, in people with chronic, inactive Thyroid Eye Disease. The drug works by blocking a protein that causes eye problems. Participants will receive the treatment periodically over several months. TEPEZZA® was approved in the USA for the treatment of thyroid eye disease.
Eligible Conditions
- Graves' Ophthalmopathy
- Graves Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Proptosis of Study Eye at Week 24
Side effects data
From 2023 Phase 4 trial • 62 Patients • NCT0458373541%
Muscle spasms
22%
Fatigue
20%
Diarrhoea
17%
Headache
15%
COVID-19
12%
Eye pain
12%
Dry skin
10%
Hypoacusis
10%
Dysgeusia
7%
Eye pruritus
7%
Glycosylated haemoglobin increased
7%
Hypertension
5%
Eye irritation
5%
Vision blurred
5%
Ear discomfort
5%
Tinnitus
5%
Nausea
5%
Infusion related reaction
5%
Diabetes mellitus
5%
Dizziness
5%
Cough
5%
Heavy menstrual bleeding
2%
Conductive deafness
2%
Abdominal pain
2%
Blepharospasm
2%
Upper respiratory tract infection
2%
Contusion
2%
Glucose tolerance impaired
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teprotumumab
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: TEPEZZAExperimental Treatment1 Intervention
Participants received intravenous infusion of 10 milligrams per kilogram (mg/kg) teprotumumab at first infusion and then 20 mg/kg once every 3 weeks (Q3W) for next 7 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Participants received teprotumumab matching placebo by intravenous infusion, Q3W for 8 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TEPEZZA
2021
Completed Phase 4
~100
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,431 Previous Clinical Trials
1,385,103 Total Patients Enrolled
Horizon Therapeutics USA, Inc.Lead Sponsor
3 Previous Clinical Trials
354 Total Patients Enrolled
MDStudy DirectorAmgen
970 Previous Clinical Trials
929,401 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not need to have eye surgery right away or have plans for eye surgery or radiation during the study.You have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease. You must not have had any surgery on your intestines in the last 6 months or have planned surgery during the trial. You must also be in clinical remission for at least 3 months and not have changed your treatment for inflammatory bowel disease in the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: TEPEZZA
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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