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Trial record 1 of 2 for:    efgartigimod | CIDP
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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) (ADHERE+)

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ClinicalTrials.gov Identifier: NCT04280718
Recruitment Status : Not yet recruiting
First Posted : February 21, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
argenx BVBA

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.

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Biological: Efgartigimod PH20 SC Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 25, 2024
Estimated Study Completion Date : May 25, 2024


Arm Intervention/treatment
Experimental: efgartigimod PH20 SC
Patients treated with efgartigimod PH20 SC
Biological: Efgartigimod PH20 SC
Subcutaneous administration of efgartigimod
Other Name: ARGX-113




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Up to 51 weeks ]

Secondary Outcome Measures :
  1. Change from baseline over time of the adjusted INCAT score [ Time Frame: Up to 48 weeks ]
  2. Change from baseline over time of the MRC Sum score [ Time Frame: Up to 48 weeks ]
  3. Change from baseline over time of I-RODS disability scores [ Time Frame: Up to 48 weeks ]
  4. Change from baseline over time of mean grip strength [ Time Frame: Up to 48 weeks ]
  5. Change from baseline over time of TUG score [ Time Frame: Up to 48 weeks ]
  6. Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline. [ Time Frame: Up to 51 weeks ]
  7. Percentage of patients with and titers of binding antibodies towards efgartigimod and/or rHuPH20 and the presence of neutralizing antibodies against efgartigimod and titers of NAb against rHuPH20. [ Time Frame: Up to 51 weeks ]
  8. Efgartigimod serum concentrations over time during the trial [ Time Frame: Up to 51 weeks ]
  9. Changes from baseline over time of serum IgG levels [ Time Frame: Up to 51 weeks ]
  10. Change from baseline over time in EQ-5D-5L [ Time Frame: Up to 48 weeks ]
  11. Change from baseline over time in BPI SF [ Time Frame: Up to 48 weeks ]
  12. Change from baseline over time in TSQM-9 [ Time Frame: Up to 48 weeks ]
  13. Change from baseline over time in RT-FSS [ Time Frame: Up to 48 weeks ]
  14. Change from baseline over time in HADS [ Time Frame: Up to 48 weeks ]
  15. Percentage of patients performing self-administration over time [ Time Frame: Up to 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 method of contraception (failure rate of less than 1% per year) from baseline to 90 days after the last administration of IMP
  5. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom and his partner must use a highly effective method of contraception (failure rate of less than 1% per year) from baseline to 90 days after the last administration of IMP. Male patients practicing true sexual abstinence (when this is in line with the preferred and usual life style of the participant) can be included. Sterilized male patients who have had vasectomy with documented aspermia post-procedure can be included. In addition, male patients are not allowed to donate sperm from baseline to 90 days after the last administration of IMP.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280718


Contacts
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Contact: Antonio Guglietta +1 857-350-4834 ClinicalTrials@argenx.com

Sponsors and Collaborators
argenx BVBA
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Responsible Party: argenx BVBA
ClinicalTrials.gov Identifier: NCT04280718    
Other Study ID Numbers: ARGX-113-1902
2019-003107-35 ( EudraCT Number )
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases