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ADAPT+: A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.

Sponsor
argenx (Industry)
Overall Status
Completed
CT.gov ID
NCT03770403
Collaborator
(none)
151
Enrollment
52
Locations
1
Arm
40
Actual Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.

Condition or Disease Intervention/Treatment Phase
  • Biological: ARGX-113
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
151 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Jun 23, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ARGX-113

Biological: ARGX-113
Intravenous administration of ARGX-113
Other Names:
  • efgartigimod

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability as measured by the incidence of treatment emergent (serious) adverse events in the AChR-positive population. [Up to 3 years]

    Secondary Outcome Measures

    1. Safety and Tolerability as measured by the incidence of treatment emergent (serious) adverse events in the overall population (AChR-Ab seropositive patients and AChR-Ab seronegative patients). [Up to 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.

    2. Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as specified in the protocol.

    Other more specific inclusion criteria are further defined in the protocol.

    Exclusion Criteria:

    1. Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might jeopardize the safety of the patient in that trial.

    2. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women or childbearing potential should have a negative urine pregnancy test at SEB.

    3. Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing.

    4. Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) seropositivity.

    Other, more specific exclusion criteria are further defined in the protocol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigator Site 42 Carlsbad California United States 92011
    2 Investigator Site 8 Los Angeles California United States 90033
    3 Investigator Site 33 Orange California United States 92868
    4 Investigator Site 21 Palo Alto California United States 94304
    5 Investigator Site 41 Jacksonville Florida United States 32209
    6 Investigator Site 4 Tampa Florida United States 33612
    7 Investigator Site 14 Kansas City Kansas United States 66160
    8 Investigator Site 32 Detroit Michigan United States 48201
    9 Investigator Site 2 Chapel Hill North Carolina United States 27599
    10 Investigator Site 18 Cleveland Ohio United States 44195
    11 Investigator Site 12 Portland Oregon United States 97239
    12 Investigator Site 1 Cordova Tennessee United States 38018
    13 Investigator Site 3 San Antonio Texas United States 78229
    14 Investigator Site 37 Charlottesville Virginia United States 22908
    15 Investigator Site 11 Edegem Belgium 2650
    16 Investigator Site 7 Ghent Belgium 9000
    17 Investigator Site 20 Toronto Ontario Canada M5G 2C4
    18 Investigator Site 25 Montréal Quebec Canada H3A 2B4
    19 Investigator Site 16 Brno Czechia 625 00
    20 Investigator Site 19 Ostrava-Poruba Czechia 70852
    21 Investigator Site 30 Praha Czechia 12800
    22 Investigator Site 49 Aarhus Denmark
    23 Investigator Site 17 Copenhagen Denmark DK-2100
    24 Investigator Site 50 Bordeaux France
    25 Investigator Site 51 Marseille France
    26 Investigator Site 45 Tbilisi Georgia 0112
    27 Investigator Site 31 Tbilisi Georgia 0114
    28 Investigator Site 46 Tbilisi Georgia 0114
    29 Investigator Site 28 Berlin Germany 10117
    30 Investigator Site 35 Budapest Hungary 1204
    31 Investigator Site 52 Szeged Hungary
    32 Investigator Site 10 Milano MI Italy 20133
    33 Investigator Site 5 Napoli Italy 80131
    34 Investigator Site 38 Roma Italy 00189
    35 Investigator Site 24 Sapporo Hokkaido Japan 060-8543
    36 Investigator Site 13 Hanamaki-shi Iwate Japan 025-0075
    37 Investigator Site 27 Sendai Miyagi Japan 983-8520
    38 Investigator Site 22 Suita Osaka Japan 565-0871
    39 Investigator Site 23 Ōsaka-sayama Osaka Japan 589-8511
    40 Investigator Site 40 Meguro Tokyo Japan 153-8515
    41 Investigator Site 43 Shinjuku-Ku Tokyo Japan 160-0023
    42 Investigator Site 47 Chiba Japan
    43 Investigator Site 44 Hiroshima Japan 730-8518
    44 Investigator Site 48 Minato Japan
    45 Investigator Site 36 Leiden Netherlands 2333 ZA
    46 Investigator Site 9 Gdańsk Poland 80-952
    47 Investigator Site 29 Katowice Poland 40-123
    48 Investigator Site 6 Kraków Poland 31-505
    49 Investigator Site 15 Warszawa Poland 02-097
    50 Investigator Site 34 Novosibirsk Russian Federation 630087
    51 Investigator Site 39 Samara Russian Federation 443095
    52 Investigator Site 26 Belgrade Serbia 11000

    Sponsors and Collaborators

    • argenx

    Investigators

    • Study Director: Sabine Coppieters, MD, argenx

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    argenx
    ClinicalTrials.gov Identifier:
    NCT03770403
    Other Study ID Numbers:
    • ARGX-113-1705
    • 2018-002133-37
    First Posted:
    Dec 10, 2018
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myasthenia Gravis
    Muscle Weakness
    Paresis

    Study Results

    No Results Posted as of Jul 11, 2022