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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 February 2021
Main ID:  NCT04280718
Date of registration: 20/02/2020
Prospective Registration: Yes
Primary sponsor: argenx
Public 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) ADHERE+
Scientific 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)
Date of first enrolment: September 18, 2020
Target sample size: 360
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04280718
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Georgia Israel Poland Russian Federation Serbia Ukraine United States
Contacts
Name:     Antonio Guglietta
Address: 
Telephone: +1 857-350-4834
Email: ClinicalTrials@argenx.com
Affiliation: 
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Intervention(s)
Biological: Efgartigimod PH20 SC
Primary Outcome(s)
Incidence of treatment-emergent adverse events and serious adverse events [Time Frame: Up to 51 weeks]
Secondary Outcome(s)
Change from baseline over time in BPI SF [Time Frame: Up to 48 weeks]
Change from baseline over time in EQ-5D-5L [Time Frame: Up to 48 weeks]
Change from baseline over time in HADS [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 TSQM-9 [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 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 TUG score [Time Frame: Up to 48 weeks]
Changes from baseline over time of serum IgG levels [Time Frame: Up to 51 weeks]
Efgartigimod serum concentrations over time during the trial [Time Frame: Up to 51 weeks]
Percentage of patients performing self-administration over time [Time Frame: Up to 48 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]
Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration =1 point compared to baseline. [Time Frame: Up to 51 weeks]
Secondary ID(s)
2019-003107-35
ARGX-113-1902
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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