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Monoclonal Antibodies

Teprotumumab for Graves' Ophthalmopathy

Phase 3

Recruiting

Research Sponsored by Horizon Pharma USA, Inc.

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 week 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proptosis responder rate (percentage of participants with a ≥ 2-mm reduction from baseline in proptosis in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye).

Secondary outcome measures

Change from Baseline in diplopia as ordinal response categories

Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0

Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade

+4 more

Side effects data

From 2020 Phase 3 trial • 83 Patients • NCT03298867

34%

Muscle Spasms

24%

Alopecia

15%

Nausea

12%

Dry Skin

12%

Diarrhoea

12%

Fatigue

10%

Dysgeusia

10%

Amenorrhoea

10%

Headache

Madarosis

Stomatitis

Dizziness

Cough

Abdominal Pain Upper

Influenza

Infusion related reaction

Pneumothorax

100%

80%

60%

40%

20%

Study treatment Arm

Teprotumumab 20 mg/kg

Placebo

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

2018

Completed Phase 3

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Horizon Pharma USA, Inc.Lead Sponsor

22 Previous Clinical Trials

1,956 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study include individuals who are older than 60 years of age?

"Recruitment for this research is targeting individuals aged above 18 and below 80 years."

Answered by AI

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, as per clinicaltrials.gov, this trial is presently in the recruitment phase. The initial posting date was February 21st, 2024 and the latest update occurred on March 22nd, 2024. A total of 80 participants are sought from a single designated site."

Answered by AI

How large is the patient population participating in this medical study?

"Indeed, the details on clinicaltrials.gov signify that this trial is presently seeking volunteers. This particular research initiative was initially made available on February 21st, 2024, and had its most recent revision on March 22nd, 2024. The investigation aims to enroll a total of 80 participants from just one location."

Answered by AI

Has Teprotumumab been officially sanctioned by the FDA for utilization?

"Our experts at Power rate the safety of Teprotumumab as 3 on a scale of 1 to 3 due to being in Phase III, indicating existing efficacy data and repeated safety assessments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06248619.

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