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

Generalized Myasthenia Gravis Clinical Trial

— ADAPT+  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770403
• Other study ID #: ARGX-113-1705
• Secondary ID: 2018-002133-37
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2023
• Source: argenx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 30, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Generalized Myasthenia Gravis
• Muscle Weakness
• Myasthenia Gravis
• Paresis

Intervention

Biological:
• ARGX-113
Intravenous administration of ARGX-113

Locations

Country	Name	City	State
Belgium	Investigator Site 11	Edegem
Belgium	Investigator Site 7	Ghent
Canada	Investigator Site 25	Montréal	Quebec
Canada	Investigator Site 20	Toronto	Ontario
Czechia	Investigator Site 16	Brno
Czechia	Investigator Site 19	Ostrava-Poruba
Czechia	Investigator Site 30	Praha
Denmark	Investigator Site 49	Aarhus
Denmark	Investigator Site 17	Copenhagen
France	Investigator Site 50	Bordeaux
France	Investigator Site 51	Marseille
Georgia	Investigator Site 31	Tbilisi
Georgia	Investigator Site 45	Tbilisi
Georgia	Investigator Site 46	Tbilisi
Germany	Investigator Site 28	Berlin
Hungary	Investigator Site 35	Budapest
Hungary	Investigator Site 52	Szeged
Italy	Investigator Site 10	Milano	MI
Italy	Investigator Site 5	Napoli
Italy	Investigator Site 38	Roma
Japan	Investigator Site 47	Chiba
Japan	Investigator Site 13	Hanamaki-shi	Iwate
Japan	Investigator Site 44	Hiroshima
Japan	Investigator Site 40	Meguro	Tokyo
Japan	Investigator Site 48	Minato
Japan	Investigator Site 23	Osaka-sayama	Osaka
Japan	Investigator Site 24	Sapporo	Hokkaido
Japan	Investigator Site 27	Sendai	Miyagi
Japan	Investigator Site 43	Shinjuku-Ku	Tokyo
Japan	Investigator Site 22	Suita	Osaka
Netherlands	Investigator Site 36	Leiden
Poland	Investigator Site 9	Gdansk
Poland	Investigator Site 29	Katowice
Poland	Investigator Site 6	Kraków
Poland	Investigator Site 15	Warszawa
Russian Federation	Investigator Site 34	Novosibirsk
Russian Federation	Investigator Site 39	Samara
Serbia	Investigator Site 26	Belgrade
United States	Investigator Site 42	Carlsbad	California
United States	Investigator Site 2	Chapel Hill	North Carolina
United States	Investigator Site 37	Charlottesville	Virginia
United States	Investigator Site 18	Cleveland	Ohio
United States	Investigator Site 1	Cordova	Tennessee
United States	Investigator Site 32	Detroit	Michigan
United States	Investigator Site 41	Jacksonville	Florida
United States	Investigator Site 14	Kansas City	Kansas
United States	Investigator Site 8	Los Angeles	California
United States	Investigator Site 33	Orange	California
United States	Investigator Site 21	Palo Alto	California
United States	Investigator Site 12	Portland	Oregon
United States	Investigator Site 3	San Antonio	Texas
United States	Investigator Site 4	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
argenx

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Denmark,  France,  Georgia,  Germany,  Hungary,  Italy,  Japan,  Netherlands,  Poland,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (electrocardiogram [ECG], radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of participant's last visit were considered as TEAEs. A serious AE (SAE) was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant.	TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years
Secondary	Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population	Overall population included both AChR-Ab seropositive and AChR-Ab seronegative participants. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (ECG, radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of participant's last visit were considered as TEAEs. An SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant.	TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years