Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Conditions
- damaged myelin sheath of nerve fibersinflammation of peripheral nervous system10012303
- Registration Number
- NL-OMON52460
- Lead Sponsor
- Argenx BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 4
1. Ability to understand the requirements of the trial, provide written
informed consent (including consent for the use and disclosure of
research-related health information), willingness and ability to comply with
the trial protocol procedures (including required trial visits) of this trial.
2.a. Male or female patient with one of the following options:
- Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and
are considered to be eligible for treatment with efgartigimod PH20 SC; or
- Have deteriorated during Stage B of the ARGX-113-1802 trial and are
considered to be eligible for treatment with efgartigimod PH20 SC, or
- Have been offered the participation in the OLE trial due to early termination
of the ARGX-113-1802 trial (because sufficient events for the primary endpoint
analysis of the that trial have been reached and it is stopped) and are
considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
- Have completed the Week-48 visit of the previous cycle of the OLE trial and
are considered to be eligible to continue with efgartigimod PH20 SC treatment.
Optional Dosing Frequency Substudy: Note that after a minimum period of weekly
dosing in this OLE trial, as specified in a separate protocol appendix for a
dosing frequency substudy, patients who have a stable clinical condition for at
least 12 weeks will be offered the option to receive less frequent dosing to
evaluate the maintenance of the clinical condition by administration of
efgartigimod PH20 SC 1000 mg at 2 lower dosing frequencies.
3. Women of childbearing potential who have a negative urine pregnancy test at
baseline before IMP administration.
4.a. Women of childbearing potential must use an acceptable method of
contraception from signing the ICF untul the date of the last dose of IMP.
5. Inclusion criterion removed via protocol amendment #4.
1. Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the
previous OLE participation occurred more than 14 days prior to SD1 of the OLE
trial or the start of a new treatment cycle in the OLE trial and more than 21
days since the last dose of IMP.
2. Pregnant and lactating women and those intending to become pregnant during
the trial.
3. a. Patients with clinical evidence of other significant serious disease or
patients who underwent a recent or have a planned major surgery, or patients
who (intend to) use prohibited medications and therapies during the trial, or
any other reason which could confound the results of the trial or put the
patient at undue risk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>• Safety and tolerability of the drug:<br /><br>- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse<br /><br>events (SAEs) by system organ class (SOC) and preferred term (PT);<br /><br>- Incidence of clinically significant laboratory abnormalities.</p><br>
- Secondary Outcome Measures
Name Time Method