Trial Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients with Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
NCT ID:
NCT06298552
Condition:
Generalized Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
Efgartigimod IV
Description:
Intravenous infusion of efgartigimod
Arm group label:
Efgartigimod IV
Arm group label:
Placebo
Intervention type:
Other
Intervention name:
Placebo IV
Description:
Intravenous infusion of placebo
Arm group label:
Placebo
Summary:
The primary purpose of this study is to measure the efficacy and safety of efgartigimod
intravenously (IV) compared to placebo in participants with Acetylcholine Receptor
Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other
objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod.
Study will consist of:
- Screening
- Part A: participants will be randomized to receive either efgartigimod IV or placebo
- Part B: participants completing part A will receive open-label efgartigimod IV
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The participant is at least 18 years of age and the local legal age of consent for
clinical studies when signing the ICF.
- The participant is capable of providing signed informed consent and following with
protocol requirements.
- The participant agrees to use contraceptive measures consistent with local
regulations and the women of child-bearing potential (WOCBP) must have a negative
serum pregnancy test result at screening and a negative urine pregnancy test result
at baseline before receiving the study drug.
- The participant has no known weakness in infancy and later develop fatigable
weakness after aged 16 years and diagnosed with acquired gMG of both of the
following:
1. History of abnormal neuromuscular transmission demonstrated by single fiber
electromyography or repetitive nerve stimulation (RNS) or is
anti-muscle-specific kinase antibodies (MuSK-Ab) seropositive
2. Either a history of positive edrophonium chloride test OR a demonstrated
improvement in MG signs with treatments such as oral acetylcholinesterase
(AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenous
immunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment
- The participant is receiving a stable dose of MG therapy before screening that
includes acetylcholinesterase (AChE) inhibitors, steroids, or nonsteroidal
immunosuppressive therapies (NSISTs) in combination or alone.
Exclusion Criteria:
- Known autoimmune disease or any medical condition that would interfere with an
accurate assessment of clinical symptoms of gMG or puts the participant at undue
risk
- History of malignancy, cancer, unless considered cured by adequate treatment with no
evidence of recurrence for ≥3 years. Adequately treated participants with the
following cancers can be included at any time: Basal cell or squamous cell skin
cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental
histological findings of prostate cancer
- Clinically significant active infection that is not sufficiently resolved in the
investigator's opinion or positive serum test at screening for active infection with
any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
- Current participation in another interventional clinical study or previous
participation in an efgartigimod clinical study and received at least 1 dose of the
study drug
- Known hypersensitivity to study drug or one of its excipients (inactive ingredients)
- History of or current alcohol, drug, or medication abuse as assessed by the
investigator
- Pregnant or lactating state or intention to become pregnant during the study
- Live or live-attenuated vaccine received <4 weeks before screening
- Worsening muscle weakness secondary to concurrent infections or medications
- Received a thymectomy less than 3 months before screening or thymectomy is planned
during the study
- Use of some medications before screening (more information is found in the
protocol).
The complete list of exclusion criteria can be found in the protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth Neurology - Bob Bove Neuroscience Institute
Address:
City:
Scottsdale
Zip:
85251
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Loma Linda University Health
Address:
City:
Fresno
Zip:
93701-2234
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
First Choice Neurology Boca Raton
Address:
City:
Boca Raton
Zip:
33428
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Costell, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
SFM Clinical Research LLC
Address:
City:
Boca Raton
Zip:
33487
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marc Feinberg, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
The Neurology Institute / Healthcare Innovations Institute - Coral Springs
Address:
City:
Coral Springs
Zip:
33067
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sonia Kalirao, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Neurology Associates PA
Address:
City:
Maitland
Zip:
32751
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
University of Miami Miller School of Medicine
Address:
City:
Miami
Zip:
33136-2137
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Medsol Clinical Research Center Inc
Address:
City:
Port Charlotte
Zip:
33952
Country:
United States
Status:
Recruiting
Contact:
Last name:
George Li, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
BayCare - St. Anthony's Hospital
Address:
City:
Saint Petersburg
Zip:
33705-1410
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Rosario-Prieto, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
University of South Florida (USF) Health - Morsani Center for Advanced Healthcare
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tuan Vu, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Wellstar - Augusta University Medical Center
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Northwestern Medicine - Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Kansas University Medical Center - Kansas City
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Henry Ford Health - Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Saint Louis University
Address:
City:
Saint Louis
Zip:
63106
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Rutgers-Robert Wood Johnson Medical School
Address:
City:
New Brunswick
Zip:
08901-1962
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shan Chen, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
University of North Carolina - Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599-7025
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Carolinas HealthCare System Neurosciences Institute-Neurology
Address:
City:
Charlotte
Zip:
28207-1885
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Duke University School of Medicine - Duke Early Phase Clinical Research Unit
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195-0001
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Penn Presbyterian Medical Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Erlanger Neuroscience Institute
Address:
City:
Chattanooga
Zip:
37403-2173
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
National Neuromuscular Research Institute
Address:
City:
Austin
Zip:
78756
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yessar Hussain, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298-5048
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
University of Washington Medical Center - Montlake
Address:
City:
Seattle
Zip:
98195
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sabine Coppieters, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Cyprus Institute of Neurology and Genetics
Address:
City:
Egkomi
Zip:
2371
Country:
Cyprus
Status:
Recruiting
Contact:
Last name:
Kleopas Kleopa, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
West Georgia Medical Center
Address:
City:
Kutaisi
Zip:
4600
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Tamar Janelidze, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Pineo Medical Ecosystem
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Alexander Tsiskaridze, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
New Hospitals
Address:
City:
Tbilisi
Zip:
0114
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Temur Margania, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
LLC Caucasus Medical Centre
Address:
City:
Tbilisi
Zip:
0186
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Madona Sekhniashvili, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
University General Hospital of Patras
Address:
City:
Patra
Zip:
265 04
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Elisabeth Chroni, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Centrum Medyczne Neurologia Slaska
Address:
City:
Katowice
Zip:
40-689
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Marek Smilowski, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Krakowska Akademia Neurologii Sp. z o.o.
Address:
City:
Kraków
Zip:
31-505
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Andrzej Szczudlik, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
CLINIREM Sp z o.o.
Address:
City:
Lublin
Zip:
20-883
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Urszula Chyrchel-Paszkiewicz, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Opsta bolnica MSB - Medicinski Sistemi Beograd
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Contact:
Last name:
Dragana Lavrnic, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Facility:
Name:
Hospital Universitario Vall d'Hebron - PPDS
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Raúl Juntas Morales, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Start date:
April 16, 2024
Completion date:
July 23, 2027
Lead sponsor:
Agency:
argenx
Agency class:
Industry
Source:
argenx
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06298552
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