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Monoclonal Antibodies

Efgartigimod for Thyroid Eye Disease (UplighTED Trial)

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 up to week 24 of the double-blinded treatment period
Awards & highlights
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to week 24 of the double-blinded treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 of the double-blinded treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline

Side effects data

From 2023 Phase 3 trial • 207 Patients • NCT04687072
31%
Blood urine present
25%
Ecchymosis
25%
Petechiae
23%
Haematuria
16%
Contusion
15%
Epistaxis
14%
Mouth haemorrhage
13%
COVID-19
12%
Headache
11%
Purpura
10%
Gingival bleeding
10%
Injection site haemorrhage
9%
Upper respiratory tract infection
9%
Injection site bruising
7%
Injection site reaction
7%
Anaemia
7%
Oral blood blister
7%
Injection site erythema
6%
Urinary tract infection
6%
Fatigue
6%
Injection site pain
6%
Dizziness
5%
Diarrhoea
5%
Injection site rash
5%
Hyperuricaemia
5%
Haematoma
5%
Hypertension
2%
Vessel puncture site haemorrhage
2%
C-reactive protein increased
2%
Dyspepsia
2%
Arthralgia
1%
COVID-19 pneumonia
1%
Meningitis aseptic
1%
Abdominal distension
1%
Haematochezia
1%
Immune thrombocytopenia
1%
Amaurosis fugax
1%
Vitreous haemorrhage
1%
Melaena
1%
Cholecystitis acute
1%
Haemoglobin decreased
1%
Cerebral infarction
1%
Intermenstrual bleeding
1%
Thrombocytopenia
1%
Urosepsis
1%
Heavy menstrual bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efgartigimod PH20 SC
Placebo PH20 SC

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: 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

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
71 Previous Clinical Trials
10,972 Total Patients Enrolled
~69 spots leftby Feb 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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