Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ended
Participants planned
60
Countries
1
Sites
4
Chronic inflammatory demyelinating polyneuropathy (CIDP)
To evaluate the effect of SCIG versus IVIG in de-novo CIDP patients during a treatment period of 26 weeks (phase I)
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- completed 30 Apr 2026
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- CSL Behring
External identifiers
- EU CT number
- 2024-515898-96-01
- EudraCT number
- 2018-003592-34
- ClinicalTrials.gov
- NCT04589299
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Dose response
To evaluate the effect of SCIG versus IVIG in de-novo CIDP patients during a treatment period of 26 weeks (phase I)
Secondary objectives 1
- To evaluate a standardized reductino of dosage regimen to identify the lowest effective dosage of immunoglobulin (phase II)
Conditions and MedDRA coding
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515898-96-00 | Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy | Region Midtjylland |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients diagnosed with typical or pure motor CIDP fulfilling the European Federation of Neurological Societies / Peripheral Nerve Society (EFNS/PNS) clinical and elctrophysiological criteria for definite or propable CIDP; Age > 18 and <80 years at inclusion; Overall disability sum score (ODSS) > 1
Exclusion criteria 1
- Previous treatment with immmunoglobulin; Pregnancy; Malignancies; Other causes of neuropathy (Diabetes Mellitus); Severe medical diseases; Other immunomodulating treatment in the last 6 weeks prior to inclusion; Hepatitis B and C or HIV; Lactation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Change in Overall Disability Sum score (ODSS) measured by questionnaire from baseline until end of phase I (26 weeks)
- Change in Overall Disability Sum score (ODSS) measured by questionnaire from start of phase II and until the lovest effective dosage of immunoglobulin has been reached (up til 60 weeks)
Secondary endpoints 6
- Change in parameters describing muscle strength and sensory: Grip strength, MRC-score, INCAT Sensory Sum Score (ISSS)
- Change in parameters describing functional ability: 10-meter-walk test (10-MWT), 6-spot-step test (6-SST), 9-hole-peg test (9-HPT)
- Change in parameters describing disability, quality of life, pain and treatment satisfaction: QoL (EQ-5D-5L), Fatigue Severity Scale (FSS), Neuropathic Pain Symptom Inventory (NPSI), Rasch built overall disability scale (RODS) and Treatment Satisfaction Questionnaire for Medication (TSQM)
- Serum samples: Plasma IgG
- Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count.
- Fluctuations in describing parameter in each arm at pre-defined time points according to IVIG infusions (pre versus post IVIG): Week 0, 4 and 20 versus week 2, 14 and 26
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hizentra 200 mg/ml solution for subcutaneous injection
PRD332108 · Product
- Active substance
- Human Normal Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 9 g gram(s)
- Max total dose
- 65 g gram(s)
- Max treatment duration
- 74 Week(s)
- Authorisation status
- Authorised
- ATC code
- J06BA01 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/11/687/012
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Privigen 100 mg/ml solution for infusion
PRD339229 · Product
- Active substance
- Human Normal Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 60 g gram(s)
- Max total dose
- 240 g gram(s)
- Max treatment duration
- 74 Week(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/08/446/006
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Lars Markvardsen
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Lars Markvardsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 60 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Odense University Hospital
Neurology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Neurology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Midtjylland
Neurology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
Neurology, Ladegaardsgade 5, 9000, Aalborg
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | SIDEC protokol | 3.0 |
| Recruitment arrangements (for publication) | Recruitment arrangements CTIS | 1 |
| Subject information and informed consent form (for publication) | SIDEC deltagerinfo | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2018-003592-34 Produktresume Hizentra 270219 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 2018-003592-34 Produktresume Privigen 270219 | 1 |
| Synopsis of the protocol (for publication) | SIDEC protokolresume | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Denmark | Acceptable 2024-10-11
|
2024-10-15 |