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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
ADAPTSC+ 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.Check my eligibility
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.See study design
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.
ADAPTSC+ Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of Adverse Events (AEs)
Incidence of Adverse Events of Special Interest (AESI)
Incidence of Serious Adverse Events (SAEs)
Secondary outcome measures
Changes in EuroQoL 5 Dimensions 5-Level (EQ-5D-5L) visual analog scale (VAS) score from baseline
Changes in total Myasthenia Gravis Quality of Life Questionnaire (15-item scale revised) (MG-QoL15r) from baseline
Cycle baseline by cycle (for EQ-5D-5L)
+24 moreSide effects data
From 2021 Phase 3 trial • 110 Patients • NCT0473543215%
Injection site rash
13%
Headache
13%
Injection site erythema
11%
Myasthenia gravis
9%
Injection site pruritus
7%
Injection site bruising
5%
Injection site pain
4%
Fatigue
2%
Fall
2%
Cellulitis
2%
Humerus fracture
2%
Dyspnoea
2%
Optic neuritis
2%
Syncope
2%
Diarrhoea
2%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efgartigimod PH20 SC
Efgartigimod IV
ADAPTSC+ 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
~390
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
60 Previous Clinical Trials
9,087 Total Patients Enrolled
12 Trials studying Myasthenia Gravis
3,614 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has efgartigimod PH20 SC received official backing from the FDA?
"Efgartigimod PH20 SC is safe according to our team's estimation. We give it a score of 3 because this medication has reached Phase 3 in clinical trials, meaning that there is some data supporting both efficacy and safety."
Answered by AI
In how many different medical clinics is this research project being conducted today?
"At the moment, this trial is being conducted at 5 total sites, 3 of which are Investigator Sites: 41 - US0010015 in Kansas City, Kansas; 40 - US0010009 in San Antonio, Texas; and 38 - US0010003 in Chapel Hill, North carolina."
Answered by AI
Are people with this illness still able to enroll in the program?
"Although this clinical trial is no longer recruiting patients, the information available on clinicaltrials.gov suggests that it was a active study at some point. The study was first posted on 4/26/2021 and edited for the last time on 7/5/2022. There are 87 other studies currently looking for candidates to fill their ranks."
Answered by AI
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