CIDPPhase 2IVITOCNCT04881682
Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Phase 2 study testing Immunoadsorption and Immunoglobulins in people with CIDP, run by University of Ulm at 1 site in Germany.
Trial summary
This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIDP
- What is being tested?
- Immunoadsorption and Immunoglobulins
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2023to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of possible, probable, or definite CIDP (typical or atypical) according to European Federation of Neurological Societies (EFNS) guidelines
- Disease duration of 3 years or less
- Age 18 years or above
- Previous treatment with methyl-prednisolone and insufficient therapeutic response as judged by the treating physician, or contraindications against methyl-prednisolone, or clinically significant side effects under methyl-prednisolone therapy as judged by the treating physician
Who cannot join
- Clinical or laboratory evidence of manifest systemic infection, i.e., C-reactive protein (CRP) above 20 mg/l, or evidence of nitrite-positive urinary tract infection
- Intake of angiotensin converting enzyme inhibitor within 1 week before first treatment
- immunoglobulin A deficiency
- Other contraindications against immunoadsorption or intravenous immunoglobulins
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, 89081
Albert C Ludolph, MD, Prof., +49-731-177- ext. 1200, albert.ludolph@rku.de
Albert C Ludolph, MD, Prof.
About this study
This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
- Conditions
- CIDP
- Being tested
- Immunoadsorption, Immunoglobulins
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoadsorptionDevice
see arm/group description
ImmunoglobulinsBiological
see arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Immunoadsorption | Experimental | 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) Receives: Device: Immunoadsorption |
| Immunoglobulins | Active comparator | 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. Receives: Biological: Immunoglobulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Standard clinical score for CIDP, quantifying disability.
Measured: 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).
Measured: 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).
Measured: 15 weeks
Secondary outcomes (21)
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.
Measured: 1, 7, and 13 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Standard clinical score for CIDP, quantifying disability.
Measured: 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).
Measured: 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).
Measured: 16 weeks
Pain
Quantifying pain on a Visual Analog Scale between 0 (no pain) and 10 (maximum pain).
Measured: 1, 7, 13, and 15 weeks
N20 Latency
N20 latency of Nervus medianus (both sides) in somatosensory evoked potentials (SEPs).
Measured: 15 weeks
P40 Latency
P40 latency of Nervus tibialis (both sides) in somatosensory evoked potentials (SEPs).
Measured: 15 weeks
Nerve Conduction Velocity
Nerve conduction velocities of clinically affected nerves as measured by electroneurography (ENG).
Measured: 15 weeks
Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L)
Quality of Life Scale
Measured: 1, 7, 13, and 15 weeks
Immunoglobulin A
Immunoglobulin A serum levels
Measured: 1, 7, 13, and 15 weeks
Immunoglobulin G
Immunoglobulin G serum levels
Measured: 1, 7, 13, and 15 weeks
Immunoglobulin M
Immunoglobulin M serum levels
Measured: 1, 7, 13, and 15 weeks
Interleukin-1
Interleukin-1 serum levels
Measured: 1, 7, 13, and 15 weeks
Interleukin-6
Interleukin-6 serum levels
Measured: 1, 7, 13, and 15 weeks
Anti-contactin-1
Anti-contactin-1 serum levels
Measured: 1, 7, 13, and 15 weeks
Anti-neurofascin155
Anti-neurofascin155 serum levels
Measured: 1, 7, 13, and 15 weeks
Anti-contactin-associated-protein1
Anti-contactin-associated-protein1 serum levels
Measured: 1, 7, 13, and 15 weeks
Anti-neurofascin186
Anti-neurofascin186 serum levels
Measured: 1, 7, 13, and 15 weeks
Anti-neurofascin140
Anti-neurofascin140 serum levels
Measured: 1, 7, 13, and 15 weeks
Neurofilament Light Chain (NfL)
Neurofilament light chain (NfL) serum levels
Measured: 1, 7, 13, and 15 weeks
Therapeutic Response
Share of patients with at least 10% improvement in CIDP score compared to baseline.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 May 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIDPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Responsible party
- Principal investigator, Albert Christian Ludolph, Prof., University of Ulm
- Investigators
- Johannes Dorst, Prof, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881682
- Sponsor's protocol ID
- IVITOC 1.1
- Acronym
- IVITOC
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- ClinicalTrials.gov ID
- NCT04881682
- Acronym / sponsor ID
- IVITOC / IVITOC 1.1
- Conditions
- CIDP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption | Experimental | Device: Immunoadsorption3 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) |
| Immunoglobulins | Active comparator | Biological: Immunoglobulins5 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of possible, probable, or definite CIDP (typical or atypical) according to European Federation of Neurological Societies (EFNS) guidelines
- Disease duration of 3 years or less
- Age 18 years or above
- Previous treatment with methyl-prednisolone and insufficient therapeutic response as judged by the treating physician, or contraindications against methyl-prednisolone, or clinically significant side effects under methyl-prednisolone therapy as judged by the treating physician
Key exclusion criteria (4 listed)
- Clinical or laboratory evidence of manifest systemic infection, i.e., C-reactive protein (CRP) above 20 mg/l, or evidence of nitrite-positive urinary tract infection
- Intake of angiotensin converting enzyme inhibitor within 1 week before first treatment
- immunoglobulin A deficiency
- Other contraindications against immunoadsorption or intravenous immunoglobulins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoadsorptionsee arm/group description | Device | Immunoadsorption |
| Immunoglobulinssee arm/group description | Biological | Immunoglobulins |
Primary outcome
CIDP Score
Time frame: 15 weeks
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.
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Time frame: 15 weeks
Standard clinical score for CIDP, quantifying disability.
Oxford Muscle Strength Score (Medical Research Council, MRC)
Time frame: 15 weeks
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).
Vibration Score
Time frame: 15 weeks
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).
21 secondary outcomes
CIDP Score
Time frame: 1, 7, and 13 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Time frame: 1, 7, and 13 weeks
Oxford Muscle Strength Score (Medical Research Council, MRC)
Time frame: 16 weeks
Vibration Score
Time frame: 16 weeks
Pain
Time frame: 1, 7, 13, and 15 weeks
N20 Latency
Time frame: 15 weeks
P40 Latency
Time frame: 15 weeks
Nerve Conduction Velocity
Time frame: 15 weeks
Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L)
Time frame: 1, 7, 13, and 15 weeks
Immunoglobulin A
Time frame: 1, 7, 13, and 15 weeks
Immunoglobulin G
Time frame: 1, 7, 13, and 15 weeks
Immunoglobulin M
Time frame: 1, 7, 13, and 15 weeks
Interleukin-1
Time frame: 1, 7, 13, and 15 weeks
Interleukin-6
Time frame: 1, 7, 13, and 15 weeks
Anti-contactin-1
Time frame: 1, 7, 13, and 15 weeks
Anti-neurofascin155
Time frame: 1, 7, 13, and 15 weeks
Anti-contactin-associated-protein1
Time frame: 1, 7, 13, and 15 weeks
Anti-neurofascin186
Time frame: 1, 7, 13, and 15 weeks
Anti-neurofascin140
Time frame: 1, 7, 13, and 15 weeks
Neurofilament Light Chain (NfL)
Time frame: 1, 7, 13, and 15 weeks
Therapeutic Response
Time frame: 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Dorst, Prof principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunoadsorption and Immunoglobulins in people with CIDP, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Dorst, Prof (+49 731 177 5285, johannes.dorst@uni-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIDP Score (time frame: 15 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.