A Phase 2 interventional study of Immunoadsorption and Immunoglobulins in CIDP, sponsored by University of Ulm. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Ulm · Phase 2, Interventional, and Treatment
This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
This study's planned enrollment of 20 is below the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.
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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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 cycles of immunoadsorption in week 1, 7, and 13 after randomization. One cycle consists of 5 sessions on 5 consecutive days with processing of the 2-fold plasma volume on the first day and the 2.5-fold plasma volume on consecutive days, using regenerative adsorbers (Therasorb, Miltenyi Biotec, Bergisch Gladbach)
Device: Immunoadsorption
5 cycles of intravenous immunoglobulins in week 1, 4, 7, 10, and 13 after randomization. The first cycle consists of 5 intravenous applications of immunoglobulins on 5 consecutive days in a dosage of 0.4 g per kg body weight per day. Subsequent cycles consist of 2 intravenous applications of immunoglobulins on 2 consecutive days in a dosage of 0.5 g per kg body weight per day.
Biological: Immunoglobulins
see arm/group description
see arm/group description
CIDP Score
The CIDP Score is a combined score of Inflammatory Cause and Treatment (INCAT) Disability Score, Oxford Muscle Strength Score, and Vibration Score, with each subscore equally weighted.
Time frame: 15 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Standard clinical score for CIDP, quantifying disability.
Time frame: 15 weeks
Oxford Muscle Strength Score (Medical Research Council, MRC)
Standard clinical score for evaluation of muscle strength / paresis. Muscle strength is evaluated on a scale between 0/5 (no movement) and 5/5 (full strength) at 8 pre-defined muscles (one proximal and one distal muscle at each extremity).
Time frame: 15 weeks
Vibration Score
Standard clinical score for evaluation of pallesthesia, using a 256 Hz tuning fork. The individual perception threshold for vibration sensations on a scale between 0/8 (no perception) and 8/8 (normal perception) will be determined at 4 predefined spots (processus styloideus radii and malleolus lateralis on each side).
Time frame: 15 weeks
CIDP Score
The CIDP Score is a combined score of Inflammatory Cause and Treatment (INCAT) Disability Score, Oxford Muscle Strength Score, and Vibration Score, with each subscore equally weighted.
Time frame: 1, 7, and 13 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Standard clinical score for CIDP, quantifying disability.
Time frame: 1, 7, and 13 weeks
Oxford Muscle Strength Score (Medical Research Council, MRC)
Standard clinical score for evaluation of muscle strength / paresis. Muscle strength is evaluated on a scale between 0/5 (no movement) and 5/5 (full strength) at 8 pre-defined muscles (one proximal and one distal muscle at each extremity).
Time frame: 16 weeks
Vibration Score
Standard clinical score for evaluation of pallesthesia, using a 256 Hz tuning fork. The individual perception threshold for vibration sensations on a scale between 0/8 (no perception) and 8/8 (normal perception) will be determined at 4 predefined spots (processus styloideus radii and malleolus lateralis on each side).
Time frame: 16 weeks
Pain
Quantifying pain on a Visual Analog Scale between 0 (no pain) and 10 (maximum pain).
Time frame: 1, 7, 13, and 15 weeks
N20 Latency
N20 latency of Nervus medianus (both sides) in somatosensory evoked potentials (SEPs).
Time frame: 15 weeks
P40 Latency
P40 latency of Nervus tibialis (both sides) in somatosensory evoked potentials (SEPs).
Time frame: 15 weeks
Nerve Conduction Velocity
Nerve conduction velocities of clinically affected nerves as measured by electroneurography (ENG).
Time frame: 15 weeks
Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L)
Quality of Life Scale
Time frame: 1, 7, 13, and 15 weeks
Immunoglobulin A
Immunoglobulin A serum levels
Time frame: 1, 7, 13, and 15 weeks
Immunoglobulin G
Immunoglobulin G serum levels
Time frame: 1, 7, 13, and 15 weeks
Immunoglobulin M
Immunoglobulin M serum levels
Time frame: 1, 7, 13, and 15 weeks
Interleukin-1
Interleukin-1 serum levels
Time frame: 1, 7, 13, and 15 weeks
Interleukin-6
Interleukin-6 serum levels
Time frame: 1, 7, 13, and 15 weeks
Anti-contactin-1
Anti-contactin-1 serum levels
Time frame: 1, 7, 13, and 15 weeks
Anti-neurofascin155
Anti-neurofascin155 serum levels
Time frame: 1, 7, 13, and 15 weeks
Anti-contactin-associated-protein1
Anti-contactin-associated-protein1 serum levels
Time frame: 1, 7, 13, and 15 weeks
Anti-neurofascin186
Anti-neurofascin186 serum levels
Time frame: 1, 7, 13, and 15 weeks
Anti-neurofascin140
Anti-neurofascin140 serum levels
Time frame: 1, 7, 13, and 15 weeks
Neurofilament Light Chain (NfL)
Neurofilament light chain (NfL) serum levels
Time frame: 1, 7, 13, and 15 weeks
Therapeutic Response
Share of patients with at least 10% improvement in CIDP score compared to baseline.
Time frame: 15 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.
Supporting information: Study protocol
Time frame: 3 months after publication until 5 years after publication
Access criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.
Data sharing details ↗ · www.uniklinik-ulm.de
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →