Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug shows promise for Long-Term control of rare Muscle-Weakening disease

NCT ID NCT04818671

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the long-term safety of efgartigimod injections in 184 people with generalized myasthenia gravis, a chronic disease that causes muscle weakness. Participants received repeated treatment cycles over time. The goal was to see if the drug is safe and tolerable when used long-term, and to measure its effects on daily living and antibody levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efgartigimod (a drug that lowers certain antibodies)
What this could lead to
If successful, this could provide a long-term treatment option to control symptoms of generalized myasthenia gravis.
What could go wrong
This is an open-label study without a placebo group, so results may be less reliable. The drug lowers IgG levels, which may increase infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

184 people

The number who actually took part.

Started

Apr 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Previously participated in antecedent studies ARGX-113-2001 or ARGX-113-1705 and are eligible for roll over. 3. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and: * Women of Child bearing potential (WOCBP) must have a negative urine pregnancy test at baseline before investigational medicinal product (IMP) can be administered. Exclusion Criteria: 1. The participant was discontinued early from studies ARGX-113-2001 or ARGX-113-1705, unless the reason for discontinuation from study ARGX-113-1705 was to roll over into study ARGX-113-2002. a. Participants who, in the investigator's judgment, are not benefiting from efgartigimod IV in study ARGX-113-1705 Part B are not eligible for roll over into ARGX-113-2002. 2. Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of investigational medicinal product (IMP) 3. Has any of the following medical conditions: 1. Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at roll-over 2. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk 3. History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of investigational medicinal product (IMP). Participants with the following cancers can be included at any time: * adequately treated 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 (TNM classification of malignant tumors stage T1a or T1b) 4. Clinical evidence of other significant serious diseases, or the participant has had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk 4. Received a live-attenuated vaccine within 28 days prior to study entry or plan to receive a live-attenuated vaccine during the study 5. A known hypersensitivity reaction to efgartigimod, rHuPH20, or any of its excipients

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Generalized myasthenia gravis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Generalized myasthenia gravis

Contacts and locations

Locations

  • Investigator Site 1 - GEO9950001

    Tbilisi, 0114, Georgia

  • Investigator Site 25 - DE490006

    Berlin, 10117, Germany

  • Investigator Site 26 - DE490009

    Münster, 48149, Germany

  • Investigator Site 27 - JP0810008

    Sapporo, 060 8542, Japan

  • Investigator Site 28- JP0810059

    Ōta-ku, Tokyo, 143-8541, Japan

  • Investigator Site 29- RU0070002

    Novosibirsk, 630087, Russia

  • Investigator Site 30 - RU0070014

    Saint Petersburg, 194354, Russia

  • Investigator Site 31 - ES0340038

    Barcelona, 08041, Spain

  • Investigator Site 32 - GEO9950004

    Tbilisi, K'alak'i T'bilisi, 0160, Georgia

  • Investigator Site 33 - GEO9950016

    Tbilisi, K'alak'i T'bilisi, 016, Georgia

  • Investigator Site 34 - IT0390007

    Naples, 80138, Italy

  • Investigator Site 35 - IT0390008

    Roma, 00189, Italy

  • Investigator Site 36 - JP0810055

    Sapporo, Hokkaido, 063-0005, Japan

  • Investigator Site 37 - ES0340021

    Barcelona, 08035, Spain

  • Investigator Site 38 - US0010003

    Chapel Hill, North Carolina, 27514, United States

  • Investigator Site 39 - US0010006

    Tampa, Florida, 41076, United States

  • Investigator Site 40 - US0010009

    San Antonio, Texas, 78229, United States

  • Investigator Site 41 - US0010015

    Kansas City, Kansas, 66160, United States

  • Investigator Site 42 - US0010019

    Cleveland, Ohio, 44195, United States

  • Investigator Site 43 - US0010066

    Austin, Texas, 78759, United States

  • Investigator Site 44 - US0010077

    Durham, North Carolina, 27710, United States

  • Investigator Site 45 - US0010108

    Boca Raton, Florida, 33428, United States

  • Investigator Site 46 - US0010111

    Amherst, New York, 14226, United States

  • Investigator Site 47 - US0010021

    Palo Alto, California, 94304, United States

  • Investigator site 10 - HU0360013

    Budapest, 1082, Hungary

  • Investigator site 11 - IT0390003

    Milan, 20133, Italy

  • Investigator site 12 - JP0810002

    Chiba, Chiba-Shi, 260-8677, Japan

  • Investigator site 13 - JP0810005

    Sendai, 983-8520, Japan

  • Investigator site 14 - JP0810007

    Osaka, 565-0871, Japan

  • Investigator site 15 - JP0810009

    Tokyo, 160-0023, Japan

  • Investigator site 16 - NL0310001

    Leiden, 2333, Netherlands

  • Investigator site 17 - PL0480001

    Gdansk, 80-952, Poland

  • Investigator site 18 - PL0480005

    Krakow, 31-505, Poland

  • Investigator site 19 - PL0480007

    Katowice, 40-123, Poland

  • Investigator site 2 - GEO9950002

    Tbilisi, 0112, Georgia

  • Investigator site 20 - PL0480018

    Lublin, 20-093, Poland

  • Investigator site 21 - PL0480022

    Warsaw, 02-097, Poland

  • Investigator site 22 - PL0480065

    Krakow, 31-426, Poland

  • Investigator site 23 - ES0340039

    Valencia, 46026, Spain

  • Investigator site 24 - CZ4200005

    Brno, 625 00, Czechia

  • Investigator site 3 - GEO9950003

    Tbilisi, 0114, Georgia

  • Investigator site 4 - US0010110

    Port Charlotte, Florida, 33952, United States

  • Investigator site 5 - BE0320007

    Ghent, 9000, Belgium

  • Investigator site 6 - US0010032

    Carlsbad, California, 92011, United States

  • Investigator site 7 - US0010008

    Cordova, Tennessee, 38018, United States

  • Investigator site 8 - JP0810004

    Hanamaki, Iwate, 025-0082, Japan

  • Investigator site 9 - HU0360012

    Budapest, 1204, Hungary

More trials for these conditions

Other studies related to the condition(s) this trial covers.