An observational study in Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by CSL Behring. Recruiting at 27 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by CSL Behring (part of CSL Limited) · Observational
Among 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France — 8 open to participants now, 10 under way, 7 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · France.
Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, this one is one of 4 that started in 2022, is one of 9 observational ones, and was the 26th registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →8 of the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France are open now. Recruiting first, the newest first:
argenx · Sites in France, United States, Argentina and 22 more countries
Ages 18+
argenx · Sites in France, United States, Argentina and 28 more countries
Ages 18+
Dianthus Therapeutics · Sites in France, United States, Argentina and 28 more countries
Ages 18–75
Sanofi · Sites in France, United States, Argentina and 21 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in France, United States, Argentina and 16 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 16
First in 2004; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 49 across 44 observational studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 82 across the 29 interventional studies, 45 across the 9 observational. Of the 25 that completed or were terminated, 12 (48%) have results posted.
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23 of 38 have an industry lead sponsor. The 10 most frequent:
This study is registered under CSL Behring, one of the names counted as CSL Limited. Under that name alone:
CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
CSL Limited has 6 studies filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
5 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05327114Phase 3Janssen Research & Development, LLCEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2026-12-15 |
| NCT06290141Phase 3SanofiA Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2027-07-09 |
| NCT06920004Phase 3argenxA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | 2027-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT04280718argenxA 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) | 2027-04-30 |
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Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes).
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a neurological and rare type of autoimmune disorder. Intravenous immunoglobulin (IVIg) is the first-line treatment for CIDP which has been proven to be effective. For several years, published cases have suggested that the Sub-Cutaneous Ig (SCIg) may be an alternative treatment to IVIg in the treatment of CIDP. Compared to IVIg treatment, the SCIg can achieve more stable plasma IgG concentrations, suggesting a potential reduction in the dose exhaustion effect at the end of the cycle, but also fewer systemic effects. SC administration also enables more straightforward treatment to be given for ambulatory patients.
Based on the PATH study (NCT01545076), a double blind placebo-controlled, randomised, prospective, international multicentre phase III study, Hizentra® obtained an extension of its marketing authorization for the CIDP indication as maintenance treatment after stabilisation with IVIg.
However, in the "real-life" situation, the literature is still based at present on small series of patient or short-term follow-up periods.
However, the methods for switching from the IV to the SC route and the characteristics of patients receiving this treatment are not known. In addition, SCIg administration remote from a specialist centre without assistance from a health professional no longer enables a more regular assessment of the patient in terms of tolerability and efficacy.
The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes). The study duration is estimated to be 36 months in view of: a 24-month inclusion period and a 12-month follow-up period.
French cohort of patients with CIDP
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Solution for injection for subcutaneous use
Also known as: IgPro20
Length of time of Continuation of treatment
Non-continuation is defined by: * an increase in the INCAT score of over one point measured in a consultation despite a bolus dose of IVIg and/or after increasing the dose of Hizentra® * stopping treatment with Hizentra®
Time frame: up to 12 months
The time between the last dose of IVIg and starting Hizentra®
Time frame: At Baseline
The total dose of the last course of IVIg
Time frame: At Baseline
The interval between courses of IVIg
Time frame: At Baseline
The total dose of the first course of Hizentra
Time frame: At Baseline
The number of days of the first course of Hizentra
Time frame: At Baseline
Number of Self-administrations or administrations by a state-registered nurse
Time frame: Up to 12 months
The daily dose of Hizentra
Time frame: Up to 12 months
The daily volume of Hizentra
Time frame: Up to 12 months
Duration of the infusion
Time frame: Up to 12 months
Number of infusion sites
Time frame: Up to 12 months
Number of Patients completing the Patient Reported Outcome (PRO) tests at home
Time frame: Up to 12 months
Rasch-built Overall Disability Scale (RODS) incapacity scale score by patient
Time frame: Up to 12 months
10-metre walking test score by patient
Time frame: Up to 12 months
Rasch-built Overall Disability Scale (RODS) incapacity scale score by doctor
Time frame: Up to 12 months
10-metre walking test score by doctor
Time frame: Up to 12 months
Time since the diagnosis of CIDP
Time frame: At baseline
EuroQol-5D (EQ-5D) quality of life score
Time frame: Up to 12 months
Pictorial Representation of Illness and Self Measure (PRISM) score
Time frame: Up to 12 months
Started Jun 2022 (actual). Primary completion is estimated for Dec 2027, 66 months after the start.
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →