A Phase 3 interventional study of IgPro20 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by CSL Behring. Completed at 33 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by CSL Behring (part of CSL Limited) · Phase 3, Interventional, and Treatment
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Among 35 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Germany — 16 open to participants now, 18 under way, 7 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Germany.
Among the 35 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Germany, this one is the 17th largest by enrollment of the 25 interventional ones that give a count, is the only one that started in 2014, is one of 13 in phase 3, and was the 7th 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 →16 of the 35 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Germany are open now. Recruiting first, the newest first:
Heinrich-Heine University, Duesseldorf · Sites in Germany
Ages 18+
Heinrich-Heine University, Duesseldorf · Sites in Germany
Ages 18+
University of Ulm · Sites in Germany
Ages 18+
argenx · Sites in Germany, United States, Argentina and 28 more countries
Ages 18+
argenx · Sites in Germany, United States
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
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.
35 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 2 10 · Phase 3 14
First in 2004; this study’s year is marked. 1 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 82 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 106 across the 25 interventional studies, 79 across the 10 observational. Of the 16 that completed or were terminated, 10 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 35 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.
8 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Germany that are under way reach primary completion within a year, 3 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 |
| 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 |
| NCT07072676LMU KlinikumThe Use of Assistive Gait Devices Can Reduce the Risk of Falls in Patients With Neuromuscular Diseases Following a Training Period. | 2027-05-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 35 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy.
Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.
The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg bw (low-dose IgPro20) for up to 48 weeks. Subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20 immediately and will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment.
Biological: IgPro20
Number of Adverse Events (AEs) Per Infusion
Time frame: Up to 49 weeks
Time to First CIDP Relapse
Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score only).
Time frame: Up to 49 weeks
Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
Time frame: Baseline and up to 49 weeks
Change From Baseline in Medical Research Council (MRC) Score
An adapted version of the MRC sum score as published by Kleyweg and the RMC trial group was used. With the MRC sum score, the following 8 bilateral muscle pairs were assessed, and individual muscle scores as well as the sum score documented: Shoulder abduction; Elbow flexion; Wrist extension; Index finger abduction; Hip flexion; Knee extension; Foot dorsiflexion; Great toe dorsiflexion. The MRC sum score ranges from 0 (paralysis) to 80 (normal strength) points.
Time frame: Baseline and up to 49 weeks
Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)
The R-ODS is a recently published outcome measure that captures activity and social participation in subjects with Guillain-Barré Syndrome, CIDP, and monoclonal gammopathy of uncertain significance. The 24-item questionnaire covers a wide range of tasks of daily life that are each to be rated as "impossible to perform", "able to perform with difficulty", or "easy to perform" (scale of 0 - 2 points respectively). Items are sorted in order of increasing difficulty to perform, based on data from subjects with peripheral neuropathies (chronic inflammatory demyelinating polyneuropathy, Guillain-Barré Syndrome, or monoclonal gammopathy of uncertain significance) and subjects recruited at the university outpatient clinics of Rotterdam and Maastricht.
Time frame: Baseline and up to 49 weeks
Change From Baseline in Mean Grip Strength
The hand-held Vigorimeter from Martin (Tuttlingen, Germany) is a device that measures the strength of small muscles in the hand, ie, grip strength. The subject squeezes a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure is recorded via a rubber tube on a nanometer and expressed in kilopascal (kPa). At each assessment, the subject squeezes 3 times with each hand.
Time frame: Baseline and up to 49 weeks
Percentage of Subjects With Adverse Events (AEs)
Time frame: Up to 49 weeks
Number of AEs by Severity Per Infusion
Time frame: Up to 49 weeks
Percentage of Subjects With AEs by Severity
Time frame: Up to 49 weeks
Number of Causally Related AEs Per Infusion
Time frame: Up to 49 weeks
Percentage of Subjects With Causally Related AEs
Time frame: Up to 49 weeks
Number of Serious AEs Per Infusion
Time frame: Up to 49 weeks
Percentage of Subjects With Serious AEs
Time frame: Up to 49 weeks
| Milestone | IgPro20 |
|---|---|
| Started | 82 |
| Completed | 66 |
| Not completed | 16 |
| Withdrew: Adverse event | 3 |
| Withdrew: Lack of efficacy | 8 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Adverse events per infusion | IgPro20 |
|---|---|
| Number of Adverse Events (AEs) Per Infusion | 0.032 |
Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score only).
| Days | IgPro20 |
|---|---|
| Time to First CIDP Relapse | 266.0 (225.0 to NA) |
The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
| units on a scale | IgPro20 |
|---|---|
| Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score | 0.0 (-3 to 6) |
An adapted version of the MRC sum score as published by Kleyweg and the RMC trial group was used. With the MRC sum score, the following 8 bilateral muscle pairs were assessed, and individual muscle scores as well as the sum score documented: Shoulder abduction; Elbow flexion; Wrist extension; Index finger abduction; Hip flexion; Knee extension; Foot dorsiflexion; Great toe dorsiflexion. The MRC sum score ranges from 0 (paralysis) to 80 (normal strength) points.
| units on a scale | IgPro20 |
|---|---|
| Change From Baseline in Medical Research Council (MRC) Score | 0.0 (-23 to 18) |
The R-ODS is a recently published outcome measure that captures activity and social participation in subjects with Guillain-Barré Syndrome, CIDP, and monoclonal gammopathy of uncertain significance. The 24-item questionnaire covers a wide range of tasks of daily life that are each to be rated as "impossible to perform", "able to perform with difficulty", or "easy to perform" (scale of 0 - 2 points respectively). Items are sorted in order of increasing difficulty to perform, based on data from subjects with peripheral neuropathies (chronic inflammatory demyelinating polyneuropathy, Guillain-Barré Syndrome, or monoclonal gammopathy of uncertain significance) and subjects recruited at the university outpatient clinics of Rotterdam and Maastricht.
| units on a scale | IgPro20 |
|---|---|
| Change From Baseline in Rasch-built Overall Disability Scale (R-ODS) | 0.0 (-76 to 33) |
The hand-held Vigorimeter from Martin (Tuttlingen, Germany) is a device that measures the strength of small muscles in the hand, ie, grip strength. The subject squeezes a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure is recorded via a rubber tube on a nanometer and expressed in kilopascal (kPa). At each assessment, the subject squeezes 3 times with each hand.
| kPa | IgPro20 |
|---|---|
| Change From Baseline in Mean Grip Strength | -0.7 (-80 to 27) |
| percentage of subjects | IgPro20 |
|---|---|
| Percentage of Subjects With Adverse Events (AEs) | 75.6 |
| Adverse events per infusion | IgPro20 |
|---|---|
| Mild | 0.024 |
| Moderate | 0.006 |
| Severe | 0.002 |
| percentage of subjects | IgPro20 |
|---|---|
| Mild | 62.2 |
| Moderate | 29.3 |
| Severe | 9.8 |
| Adverse events per infusion | IgPro20 |
|---|---|
| Number of Causally Related AEs Per Infusion | 0.011 |
| percentage of subjects | IgPro20 |
|---|---|
| Percentage of Subjects With Causally Related AEs | 25.6 |
| Adverse events per infusion | IgPro20 |
|---|---|
| Number of Serious AEs Per Infusion | 0.001 |
| percentage of subjects | IgPro20 |
|---|---|
| Percentage of Subjects With Serious AEs | 8.5 |
Collected over Up to 49 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IgPro20 | 0/82 (0%) | 7/82 (8.5%) | 25/82 (30.5%) |
| Event | IgPro20 |
|---|---|
| Atrial FlutterCardiac disorders | 2/82 |
| Gallbladder PerforationHepatobiliary disorders | 1/82 |
| Nerve CompressionNervous system disorders | 1/82 |
| Pulmonary SepsisRespiratory, thoracic and mediastinal disorders | 1/82 |
| Urinary Tract InfectionRenal and urinary disorders | 1/82 |
| FaecalomaGastrointestinal disorders | 1/82 |
| Chronic Inflammatory Demyelinating PolyradiculoneuropathyImmune system disorders | 1/82 |
| Back PainMusculoskeletal and connective tissue disorders | 1/82 |
| Event | IgPro20 |
|---|---|
| NasopharyngitisInfections and infestations | 11/82 |
| Infusion site swellingSkin and subcutaneous tissue disorders | 9/82 |
| Infusion site swellingSkin and subcutaneous tissue disorders | 9/82 |
| Infusion site erythemaSkin and subcutaneous tissue disorders | 7/82 |
| Infusion Site erythemaSkin and subcutaneous tissue disorders | 7/82 |
| HeadacheNervous system disorders | 4/82 |
| Age, Categorical(Participants) | IgPro20 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 55 |
| >=65 years | 27 |
| Age, Continuous(years) | IgPro20 |
|---|---|
| Mean | 57.57 ± 13.224 |
| Sex: Female, Male(Participants) | IgPro20 |
|---|---|
| Female | 32 |
| Male | 50 |
| Ethnicity (NIH/OMB)(Participants) | IgPro20 |
|---|---|
| Hispanic or Latino | 14 |
| Not Hispanic or Latino | 66 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | IgPro20 |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 70 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | IgPro20 |
|---|---|
| Canada | 7 |
| Netherlands | 1 |
| United States | 9 |
| Czechia | 2 |
| Japan | 10 |
| Italy | 8 |
| United Kingdom | 4 |
| Australia | 1 |
| France | 1 |
| Germany | 29 |
| Spain | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2014 to primary completion in Jul 2017, 35 months.
Results were first posted in Oct 2018, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Hizentra
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →