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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) linked to autoimmune thyroid conditions like Graves' disease or Hashimoto's thyroiditis. Participants must have had TED symptoms start within the last year and be able to follow study procedures. They should have normal or near-normal thyroid function that is stable or being treated.Check my eligibility

What is being tested?

The trial tests Efgartigimod PH20 SC, a new medication for TED, against a placebo. Patients are randomly assigned in a 2:1 ratio to receive either the drug or placebo via injection over a 24-week period, followed by an observational phase to monitor long-term effects.See study design

What are the potential side effects?

Possible side effects of Efgartigimod PH20 SC may include reactions at the injection site, general discomfort, immune system changes leading to increased risk of infections or other immune-related issues.

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.

Has Efgartigimod been granted approval by the FDA?

"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

What is the current size of the patient cohort being observed in this clinical investigation?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is actively seeking participants. The clinical trial was initially listed on 3/27/2024 and recently revised on 4/3/2024. A total of 108 individuals are sought after at a single site for enrollment."

Answered by AI

Are potential participants currently able to apply for enrollment in this study?

"Affirmative, details from clinicaltrials.gov indicate that patient recruitment is ongoing for this investigation. The trial was first listed on 3/27/2024 and last modified on 4/3/2024. They aim to recruit a total of 108 participants at one designated site."

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/NCT06307613.

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