Generalized Myasthenia Gravis MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Efgartigimod PH20 SC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: EFGARTIGIMOD ALFA
CAS Number: 1821402-21-4
Current Sponsor code: ARGX-113
Concentration unit: millil
Sponsors
argenx BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol 2. Previously participated in antecedent studies ARGX-113-2001 or ARGX-113-1705 and are eligible for rollover 3. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and: a. Male participants: - Male participants: no male contraception is required. b. Female participants: - Women of Child bearing potential (WOCBP) must have a negative urine pregnancy test at baseline before IMP can be administered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 121 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 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 rollover 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 rollover 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 IMP 3. Have any of the following medical conditions: a. Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at rollover b. 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 c. History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for =3 years before the first administration of 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) d. 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. Had a known hypersensitivity reaction to efgartigimod, rHuPH20, or any of its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG);Secondary Objective: • To evaluate the impact of efgartigimod PH20 SC on disease severity • To evaluate the effect of efgartigimod PH20 SC on Pharmacodynamic (PD) • To evaluate the PK of efgartigimod PH20 SC • To evaluate the immunogenicity of efgartigimod PH20 SC ;Primary end point(s): • Incidence of Serious Adverse Events (SAEs) and AEs of special interest (AESIs);Timepoint(s) of evaluation of this end point: The primary end point is timeframe 'from the participant's first visit in this study until, at the latest, 31 Dec 2024'. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Myasthenia Gravis Activities of Daily Living (MG-ADL) total score changes from baseline and cycle baseline over time by cycle • Percentage reduction in levels of total immunoglobulin G (IgG) from baseline and cycle baseline over time by cycle • Percentage reduction of anti-acetylcholine receptor antibodies (AChR-Ab) from baseline and cycle baseline over time by cycle in AChR-Ab seropositive participants • Efgartigimod serum concentrations • Incidence and prevalence of anti-drug antibodies (ADAs) to efgartigimod over time ;Timepoint(s) of evaluation of this end point: All secondary end points are timeframe 'from the participant's first visit in this study until, at the latest, 31 Dec 2024''. | — |
Countries
Belgium, Czechia, Czech Republic, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russian Federation, Spain, United States
Contacts
Public Contactregulatory
argenx BV
Outcome results
None listed