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Monoclonal Antibodies
Efgartigimod for Myasthenia Gravis (ADAPTSC+ Trial)
Phase 3
Waitlist Available
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
Must not have
Has any of the following medical conditions: Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at roll-over
Received a live-attenuated vaccine within 28 days prior to study entry or plan to receive a live-attenuated vaccine during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a drug to see if it is safe and effective for long-term use in treating myasthenia gravis.
Who is the study for?
This trial is for individuals with generalized myasthenia gravis who have previously participated in specific antecedent studies. They must be able to consent, use contraception, and not be pregnant or breastfeeding. Excluded are those allergic to the study drug or its components, recently had major surgery, have serious infections or diseases that could affect results or safety.
What is being tested?
The trial tests the long-term safety of Efgartigimod PH20 SC (a subcutaneous injection) for treating myasthenia gravis. It looks at how well it works over time, its effects on quality of life and daily activities, and if patients can self-administer the treatment.
What are the potential side effects?
Potential side effects may include reactions at the injection site, changes in immune system function due to lowered IgG levels which might increase infection risk; however specific side effect profiles will be monitored throughout the study.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any uncontrolled long-term infections.
Select...
I have not received a live vaccine in the last 28 days and do not plan to during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Myasthenia Gravis Activities of Daily Living (MG-ADL) total score changes from baseline
Side effects data
From 2023 Phase 3 trial • 222 Patients • NCT0459845114%
HYPERTENSION
12%
INSOMNIA
12%
COVID-19
7%
BLOOD LACTATE DEHYDROGENASE INCREASED
7%
HYPERTRIGLYCERIDAEMIA
6%
MYOPATHY
6%
HEADACHE
6%
DEPRESSION
5%
DERMATITIS ACNEIFORM
5%
INJECTION SITE ERYTHEMA
4%
ORAL CANDIDIASIS
3%
NASOPHARYNGITIS
3%
URINARY TRACT INFECTION
3%
LEUKOCYTURIA
3%
INCREASED TENDENCY TO BRUISE
1%
SPINAL COMPRESSION FRACTURE
1%
GLOMERULONEPHRITIS
1%
DRUG ERUPTION
1%
SKIN INFECTION
1%
HYPOPROTEINAEMIA
1%
RESPIRATORY FAILURE
1%
TACHYCARDIA
1%
VISION BLURRED
1%
WEIGHT INCREASED
1%
PEMPHIGUS
1%
ERYSIPELAS
1%
VOMITING
1%
COVID-19 PNEUMONIA
1%
GASTROENTERITIS
1%
PNEUMONIA
1%
DIABETES MELLITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efgartigimod PH20 SC
Placebo PH20 SC
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: efgartigimod PH20 SCExperimental Treatment1 Intervention
Patients receiving efgartigimod PH20 subcutaneous (SC) treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
efgartigimod PH20 SC
2021
Completed Phase 3
~490
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
71 Previous Clinical Trials
10,896 Total Patients Enrolled
15 Trials studying Myasthenia Gravis
4,613 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can sign and follow the study's consent form and rules.I had cancer before but have been cancer-free for over 3 years.I do not have serious health issues or recent major surgery that could risk my safety in the study.I have had certain skin, cervical, breast, or early-stage prostate cancers but they are treated.I do not have any uncontrolled long-term infections.I have not received a live vaccine in the last 28 days and do not plan to during the study.You are allergic to efgartigimod or rHuPH20.You were part of a previous study and left early, unless you were switching to a different part of the same study.You have another autoimmune disease that could make it hard to tell if you have myasthenia gravis or could put you in danger.
Research Study Groups:
This trial has the following groups:- Group 1: efgartigimod PH20 SC
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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