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)

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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