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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) 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.
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.
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 ~ up to week 24 of the double-blinded treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 24 of the double-blinded treatment period
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 • NCT0468707231%
Blood urine present
25%
Ecchymosis
25%
Petechiae
23%
Haematuria
16%
Contusion
15%
Epistaxis
14%
Mouth haemorrhage
13%
COVID-19
12%
Headache
11%
Purpura
10%
Injection site haemorrhage
10%
Gingival bleeding
9%
Injection site bruising
9%
Upper respiratory tract infection
7%
Oral blood blister
7%
Injection site erythema
7%
Injection site reaction
7%
Anaemia
6%
Injection site pain
6%
Dizziness
6%
Urinary tract infection
6%
Fatigue
5%
Injection site rash
5%
Hyperuricaemia
5%
Hypertension
5%
Haematoma
5%
Diarrhoea
2%
Vessel puncture site haemorrhage
2%
C-reactive protein increased
2%
Dyspepsia
2%
Arthralgia
1%
Abdominal distension
1%
Haematochezia
1%
Vitreous haemorrhage
1%
Melaena
1%
Cholecystitis acute
1%
Immune thrombocytopenia
1%
Meningitis aseptic
1%
Urosepsis
1%
Amaurosis fugax
1%
COVID-19 pneumonia
1%
Thrombocytopenia
1%
Cerebral infarction
1%
Heavy menstrual bleeding
1%
Intermenstrual bleeding
1%
Haemoglobin decreased
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
72 Previous Clinical Trials
11,008 Total Patients Enrolled