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Monoclonal Antibodies

ARGX-113 for Myasthenia Gravis (ADAPT+ 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 teaes were collected from the start of first administered study treatment (day 1) up to end of follow-up, approximately up to 3 years
Awards & highlights

ADAPT+ Trial Summary

This study is evaluating whether efgartigimod is safe and tolerable in people with gMG.

Eligible Conditions
  • Myasthenia Gravis

ADAPT+ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~teaes were collected from the start of first administered study treatment (day 1) up to end of follow-up, approximately up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and teaes were collected from the start of first administered study treatment (day 1) up to end of follow-up, approximately up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in AChR-Positive Participants
Secondary outcome measures
Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population

Side effects data

From 2020 Phase 3 trial • 167 Patients • NCT03669588
29%
Headache
12%
Nasopharyngitis
11%
Upper respiratory tract infection
10%
Urinary tract infection
8%
Nausea
7%
Diarrhoea
6%
Myalgia
6%
Bronchitis
4%
Oropharyngeal pain
4%
Hypertension
4%
Cough
4%
Dizziness
1%
Rectal adenocarcinoma
1%
Myasthenia gravis
1%
Depression
1%
Thrombocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
ARGX-113
Placebo

ADAPT+ Trial Design

1Treatment groups
Experimental Treatment
Group I: ARGX-113Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARGX-113
2016
Completed Phase 3
~520

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
60 Previous Clinical Trials
9,119 Total Patients Enrolled
12 Trials studying Myasthenia Gravis
3,646 Patients Enrolled for Myasthenia Gravis
Antonio Guglietta, MDStudy Directorargenx
3 Previous Clinical Trials
224 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
191 Patients Enrolled for Myasthenia Gravis
Sabine Coppieters, MDStudy Directorargenx

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
2019. "A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03770403.
~25 spots leftby Apr 2025
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