Brief Title
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
Official Title
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)
Brief Summary
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term
safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Incidence of treatment-emergent adverse events and serious adverse events
Secondary Outcome
Change from baseline over time of the adjusted INCAT score
Condition
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Intervention
Efgartigimod PH20 SC
Study Arms / Comparison Groups
efgartigimod PH20 SC
Description: Patients treated with efgartigimod PH20 SC
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
360
Start Date
September 18, 2020
Completion Date
September 18, 2024
Primary Completion Date
September 18, 2024
Eligibility Criteria
Inclusion Criteria:
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. 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.
3. Women of childbearing potential who have a negative urine pregnancy test at baseline
before IMP administration.
4. Women of childbearing potential must use a highly effective or acceptable method of
contraception from baseline to 90 days after the last administration of IMP.
5. Male patients agree not to donate sperm during the trial period and 90 days
thereafter.
Exclusion Criteria:
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
or within 90 days after last IMP administration.
3. Patients with clinical evidence of other significant serious disease or patients who
underwent a recent or have a planned major surgery, or any other reason which could
confound the results of the trial or put the patient at undue risk.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +1 857-350-4834, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT04280718
Organization ID
ARGX-113-1902
Secondary IDs
2019-003107-35
Responsible Party
Sponsor
Study Sponsor
argenx
Study Sponsor
, ,
Verification Date
May 2022