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Trial record 2 of 2 for:    argenx | cidp

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 : Recruiting
First Posted : February 21, 2020
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
argenx

Tracking Information
First Submitted Date  ICMJE February 20, 2020
First Posted Date  ICMJE February 21, 2020
Last Update Posted Date November 29, 2021
Actual Study Start Date  ICMJE September 18, 2020
Estimated Primary Completion Date September 18, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Up to 51 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • Change from baseline over time of the adjusted INCAT score [ Time Frame: Up to 48 weeks ]
  • Change from baseline over time of the MRC Sum score [ Time Frame: Up to 48 weeks ]
  • Change from baseline over time of I-RODS disability scores [ Time Frame: Up to 48 weeks ]
  • Change from baseline over time of mean grip strength [ Time Frame: Up to 48 weeks ]
  • Change from baseline over time of TUG score [ Time Frame: Up to 48 weeks ]
  • Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline. [ Time Frame: Up to 51 weeks ]
  • 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 ]
  • Efgartigimod serum concentrations over time during the trial [ Time Frame: Up to 51 weeks ]
  • Changes from baseline over time of serum IgG levels [ Time Frame: Up to 51 weeks ]
  • Change from baseline over time in EQ-5D-5L [ Time Frame: Up to 48 weeks ]
  • Change from baseline over time in BPI SF [ Time Frame: Up to 48 weeks ]
  • Change from baseline over time in TSQM-9 [ Time Frame: Up to 48 weeks ]
  • Change from baseline over time in RT-FSS [ Time Frame: Up to 48 weeks ]
  • Change from baseline over time in HADS [ Time Frame: Up to 48 weeks ]
  • Percentage of patients performing self-administration over time [ Time Frame: Up to 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Intervention  ICMJE Biological: Efgartigimod PH20 SC
Subcutaneous administration of efgartigimod
Other Name: ARGX-113
Study Arms  ICMJE Experimental: efgartigimod PH20 SC
Patients treated with efgartigimod PH20 SC
Intervention: Biological: Efgartigimod PH20 SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2020)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 18, 2024
Estimated Primary Completion Date September 18, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sabine Coppieters, MD +1 857-350-4834 ClinicalTrials@argenx.com
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Czechia,   Denmark,   France,   Georgia,   Germany,   Israel,   Italy,   Japan,   Latvia,   Netherlands,   Poland,   Russian Federation,   Serbia,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04280718
Other Study ID Numbers  ICMJE ARGX-113-1902
2019-003107-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party argenx
Study Sponsor  ICMJE argenx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account argenx
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP