Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients with Generalized Myasthenia Gravis

Last updated: January 22, 2025
Sponsor: argenx
Overall Status: Completed

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

efgartigimod PH20 SC

Clinical Study ID

NCT04818671
ARGX-113-2002
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection.

Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods

Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must be capable of giving signed informed consent, which includes compliance withthe requirements and restrictions listed in the informed consent form (ICF) and inthis protocol.

  2. Previously participated in antecedent studies ARGX-113-2001 or ARGX-113-1705 and areeligible for roll over.

  3. Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studiesand:

  • Women of Child bearing potential (WOCBP) must have a negative urine pregnancytest at baseline before investigational medicinal product (IMP) can beadministered.

Exclusion

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 intostudy ARGX-113-2002. a. Participants who, in the investigator's judgment, are not benefiting fromefgartigimod IV in study ARGX-113-1705 Part B are not eligible for roll over intoARGX-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:

  4. Clinically significant uncontrolled chronic bacterial, viral, or fungalinfection at roll-over

  5. Any other known autoimmune disease that, in the opinion of the investigator,would interfere with accurate assessment of clinical symptoms of myastheniagravis or put the participant at undue risk

  6. History of malignancy unless deemed cured by adequate treatment with noevidence of reoccurrence for ≥3 years before the first administration ofinvestigational 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 ofmalignant tumors stage T1a or T1b)
  1. Clinical evidence of other significant serious diseases, or the participant hashad a recent major surgery, or who have any other condition that, in theopinion of the investigator, could confound the results of the study or put theparticipant at undue risk

  2. Received a live-attenuated vaccine within 28 days prior to study entry or plan toreceive a live-attenuated vaccine during the study

  3. A known hypersensitivity reaction to efgartigimod, rHuPH20, or any of its excipients

Study Design

Total Participants: 184
Treatment Group(s): 1
Primary Treatment: efgartigimod PH20 SC
Phase: 3
Study Start date:
April 26, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Investigator site 5 - BE0320007

    Gent, 9000
    Belgium

    Site Not Available

  • Investigator site 24 - CZ4200005

    Brno, 625 00
    Czechia

    Site Not Available

  • Investigator Site 1 - GEO9950001

    Tbilisi, 0114
    Georgia

    Site Not Available

  • Investigator Site 32 - GEO9950004

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Investigator Site 33 - GEO9950016

    Tbilisi, 016
    Georgia

    Site Not Available

  • Investigator site 2 - GEO9950002

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Investigator site 3 - GEO9950003

    Tbilisi, 0114
    Georgia

    Site Not Available

  • Investigator Site 25 - DE490006

    Berlin, 10117
    Germany

    Site Not Available

  • Investigator Site 26 - DE490009

    Münster, 48149
    Germany

    Site Not Available

  • Investigator site 10 - HU0360013

    Budapest, 1082
    Hungary

    Site Not Available

  • Investigator site 9 - HU0360012

    Budapest, 1204
    Hungary

    Site Not Available

  • Investigator site 11 - IT0390003

    Milano, 20133
    Italy

    Site Not Available

  • Investigator Site 34 - IT0390007

    Napoli, 80138
    Italy

    Site Not Available

  • Investigator Site 35 - IT0390008

    Roma, 00189
    Italy

    Site Not Available

  • Investigator site 12 - JP0810002

    Chiba, Chiba-Shi 260-8677
    Japan

    Site Not Available

  • Investigator Site 36 - JP0810055

    Sapporo, Hokkaido 063-0005
    Japan

    Site Not Available

  • Investigator site 8 - JP0810004

    Hanamaki, Iwate 025-0082
    Japan

    Site Not Available

  • Investigator Site 28- JP0810059

    Ota-Ku, Tokyo 143-8541
    Japan

    Site Not Available

  • Investigator site 14 - JP0810007

    Osaka, 565-0871
    Japan

    Site Not Available

  • Investigator Site 27 - JP0810008

    Sapporo, 060 8542
    Japan

    Site Not Available

  • Investigator site 13 - JP0810005

    Sendai-shi, 983-8520
    Japan

    Site Not Available

  • Investigator site 15 - JP0810009

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Investigator site 16 - NL0310001

    Leiden, 2333
    Netherlands

    Site Not Available

  • Investigator site 17 - PL0480001

    Gdańsk, 80-952
    Poland

    Site Not Available

  • Investigator site 19 - PL0480007

    Katowice, 40-123
    Poland

    Site Not Available

  • Investigator site 18 - PL0480005

    Kraków, 31-505
    Poland

    Site Not Available

  • Investigator site 22 - PL0480065

    Kraków, 31-426
    Poland

    Site Not Available

  • Investigator site 20 - PL0480018

    Lublin, 20-093
    Poland

    Site Not Available

  • Investigator site 21 - PL0480022

    Warsaw, 02-097
    Poland

    Site Not Available

  • Investigator Site 29- RU0070002

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Investigator Site 30 - RU0070014

    Saint Petersburg, 194354
    Russian Federation

    Site Not Available

  • Investigator Site 31 - ES0340038

    Barcelona, 08041
    Spain

    Site Not Available

  • Investigator Site 37 - ES0340021

    Barcelona, 08035
    Spain

    Site Not Available

  • Investigator site 23 - ES0340039

    Valencia, 46026
    Spain

    Site Not Available

  • Investigator site 6 - US0010032

    Carlsbad, California 92011
    United States

    Site Not Available

  • Investigator Site 47 - US0010021

    Palo Alto, California 94304
    United States

    Site Not Available

  • Investigator Site 45 - US0010108

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Investigator site 4 - US0010110

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Investigator Site 39 - US0010006

    Tampa, Florida 41076
    United States

    Site Not Available

  • Investigator Site 41 - US0010015

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Investigator Site 46 - US0010111

    Amherst, New York 14226
    United States

    Site Not Available

  • Investigator Site 38 - US0010003

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Investigator Site 44 - US0010077

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Investigator Site 42 - US0010019

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Investigator site 7 - US0010008

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Investigator Site 43 - US0010066

    Austin, Texas 78759
    United States

    Site Not Available

  • Investigator Site 40 - US0010009

    San Antonio, Texas 78229
    United States

    Site Not Available

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