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Monoclonal Antibodies

Efgartigimod arm for Graves' Ophthalmopathy

Phase 3

Recruiting

Research Sponsored by argenx

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 at week 24 of the double-blinded treatment period

Awards & highlights

Study Summary

This trial aims to test the effectiveness, safety, and tolerability of a drug called efgartigimod PH20 SC in people with moderate-to-severe thyroid eye disease (TED). Participants

Who is the study for?

Adults with active, moderate-to-severe thyroid eye disease (TED) who've had symptoms start within the last year can join. They must be over 18, able to consent and follow the study plan, have their thyroid condition under control or only mildly off balance. Participants need to use birth control and women must test negative for pregnancy.Check my eligibility

What is being tested?

The trial is testing Efgartigimod PH20 SC against a placebo in people with TED. It's a randomized study where two-thirds get the real drug and one-third gets a fake drug (placebo), given by injection for 24 weeks. Responders are observed for another year without treatment; nonresponders get more of the real drug.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, general discomfort or flu-like symptoms, headaches, muscle pains, and potentially others not listed here as it's being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24 of the double-blinded treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 24 of the double-blinded treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 of the double-blinded treatment period for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of participants who were proptosis responders

Secondary outcome measures

Change in proptosis measurement in the study eye from baseline

Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline

Percentage of participants with a resolution of diplopia (responders)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Efgartigimod armExperimental Treatment1 Intervention

Participants with active, moderate-to-severe TED receiving Efgartigimod PH20 SC (subcutaneously) via pre-filled syringe (PFS)

Group II: Placebo armPlacebo Group1 Intervention

Participants with active, moderate-to-severe TED receiving Placebo PH20 SC (subcutaneously) via pre-filled syringe (PFS)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Efgartigimod PH20 SC

2020

Completed Phase 3

~210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

argenxLead Sponsor

60 Previous Clinical Trials

9,147 Total Patients Enrolled

Frequently Asked Questions

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

What is the collective count of individuals actively involved in this research trial?

"Affirmative. Data available on clinicaltrials.gov indicates that this research initiative is currently in search of suitable candidates. The trial was initially listed on 3/28/2024 and underwent its latest update on 4/3/2024. Participation slots are open for a total of 108 individuals at a single designated site."

Answered by AI

Is the enrollment of participants ongoing for this study?

"Indeed, the details on clinicaltrials.gov indicate that this investigation is currently seeking suitable candidates. The trial was initially disclosed on March 28th, 2024 and last revised on April 3rd, 2024. Recruitment aims to enroll a total of 108 participants at a single designated site."

Answered by AI

What is the safety profile of the Efgartigimod treatment arm for individuals undergoing medical care?

"Based on our evaluation at Power, the safety rating for the Efgartigimod arm in this trial is 3. This score reflects robust data supporting both efficacy and safety due to its Phase 3 status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.

2024. "A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06307626.

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