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Clinical Trials List

Protocol NumberARGX-113-1902
NCT Number(ClinicalTrials.gov Identfier)NCT04280718
Active

2022-06-01 - 2027-10-31

Phase II

Not yet recruiting1

Recruiting1

Terminated5

ICD-10G36.0

Neuromyelitis optica [Devic]

ICD-9341.0

Neuromyelitis optica

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)

  • Sponsor

    PPD DEVELOPMENT (HK) LIMITED TAIWAN BRANCH

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Jia-Ying Sung Division of Neurology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 蔡乃文 Division of Neurology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Chao Chao Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 葉建宏 Division of Neurology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Han-Wei Huang Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Long-Sun Ro
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yuh-Cherng Guo Division of Neurology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Objectives

 To assess the long-term safety and tolerability of efgartigimod PH20 SC.  To determine the long-term treatment effect.  To evaluate the immunogenicity (anti-drug antibodies [ADA]) of efgartigimod and rHuPH20.  To evaluate the PK of efgartigimod PH20 SC.  To evaluate the PD effect of efgartigimod PH20 SC (ie, IgG levels).  To evaluate additional patient-reported outcomes (PROs) (including patient-reported quality of life and satisfaction with treatment).  To explore self-administration of the treatment.

Test Drug

Efgartigimod (ARGX-113)

Active Ingredient

Efgartigimod (ARGX-113)

Dosage Form

皮下注射

Dosage

180 mg/ml

Endpoints

To assess the long-term safety and tolerability of efgartigimod PH20 SC, efgartigimod co-formulated with recombinant human hyaluronic acid® PH20 (rHuPH20) for subcutaneous [SC] administration.

Inclution Criteria

Inclusion Criteria:
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.
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.
Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.

Exclusion Criteria

Exclusion Criteria:
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.
Pregnant and lactating women and those intending to become pregnant during the trial.
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 (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.

The Estimated Number of Participants

  • Taiwan

    21 participants

  • Global

    180 participants

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