A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)

Phase 1

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003107-35-BG
• Lead Sponsor: argenx BVBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-11
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

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.a. Male or female patient with 1 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 until the date of the
last dose of IMP

5. Inclusion criterion removed via protocol amendment #4.
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 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 144

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. a. 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 clinical trial of medicinal product
• Study Design: Not specified