Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy

NCT01184846 | Completed Phase 3 Results DMC

• 3 other identifiers: IgPro10_300115042009-017672-24
• Study Type: interventional
• Target: 31
• Locations: 5 countries
• Sites: 22

Brief Summary

The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Chronic inflammatory demyelinating polyneuropathy; CIDP

Outcome Measures

Primary Outcomes (1)

• Responder Rate

  Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score. Responders were defined as those subjects who: 1) demonstrated a "clinically meaningful improvement" between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with "clinically meaningful improvement" at the last study visit. "Clinically meaningful improvement" was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0.

  25 weeks

Secondary Outcomes (13)

• Change in Adjusted INCAT Score

  Up to 34 weeks

• Change in Maximum Grip Strength

  Up to 34 weeks

• Change in Medical Research Council Sum Scale (MRC)

  Up to 34 weeks

• Immunoglobulin G (IgG) Level

  At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)

• Frequency of Adverse Events (AEs)

  For the duration of the study, up to 34 weeks

Study Arms (1)

IgPro10

EXPERIMENTAL

10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.

Biological: 10% liquid formulation of human immunoglobulin

Interventions

10% liquid formulation of human immunoglobulin BIOLOGICAL

Also known as: IgPro10; Privigen

IgPro10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IVIG-untreated subjects:
• Either subjects with newly diagnosed CIDP (developing over at least 2 months) or subjects with an IVIG treatment interruption for at least 1 year with a progressive disease (deteriorating in the last 2 months) prior to enrolment.
• Actual diagnosis (including electrophysiology) of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline.
• Age ≥18 years.
• Male or female.
• Written informed consent for study participation obtained before undergoing any study specific procedures.
• IVIG-pretreated subjects:
• Being treated regularly with IVIG on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months, on a fixed dosage of ± 20 % in the last 6 months and deteriorating by at least 1 INCAT score point during the Washout Period of up to 10 weeks (except for an increase from 0 to 1 solely due to upper limb score).
• Historic diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline.
• Age ≥18 years.
• Male or female.
• Written informed consent for study participation obtained before undergoing any study specific procedures.

You may not qualify if:

• A motor syndrome that fulfils criteria for multifocal motor neuropathy (MMN) with conduction block (i.e., upper limb motor weakness without sensory deficit and with a 50% decrease in action potential amplitude or area on proximal compared with distal stimulation in motor nerves).
• CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-MGUS antibodies and patients with distal acquired demyelinating symmetric (DADS)neuropathy.
• Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or may interfere with treatment or outcome assessments with the INCAT (e.g., diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with radiculopathy, post-polio-syndrome,M. Parkinson, stroke).
• Current malignancy.
• History of cardiac insufficiency (New York Heart Association \[NYHA\] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension.
• History of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident).
• Migraine associated with IVIG infusion in the last 3 months prior to enrolment.
• Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis).
• Subjects with serum IgA level less than 50% of the lower normal limit.
• Known hyperprolinemia.
• Any condition (including alcohol, drug or medication abuse) that is likely to interfere with evaluation of the study product or satisfactory conduct of the study.
• Plasma exchange 3 months prior to enrolment.
• Treatment with immunomodulatory agents others than steroids, methotrexate or azathioprine (e.g. interferon, TNF-α inhibitors) within 6 months before enrolment.
• Treatment with rituximab in the 12 months before enrolment.
• Abnormal laboratory parameters: creatinine \> 1.5 times the upper normal limit (UNL), lactate dehydrogenase (LDH) \> 1.5 times the UNL, C-reactive protein (CRP) \> 1.5 times the UNL, hemoglobin (Hb) \< 10 g/dL.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (22)

Study Site

Brussels, Belgium

Location

Study Site

Edegem, Belgium

Location

Study Site

Ghent, Belgium

Location

Study Site

Leuven, Belgium

Location

Study Site

Helsinki, Finland

Location

Study Site

Turku, Finland

Location

Study Site

Vaasa, Finland

Location

Study Site

Limoges, France

Location

Study Site

Lyon, France

Location

Study Site

Marseille, France

Location

Study Site

Montpellier, France

Location

Study Site

Paris, France

Location

Study Site

Berlin, Germany

Location

Study Site

Feldberger Seenlandschaft, Germany

Location

Study Site

Göttingen, Germany

Location

Study Site

Itzehoe, Germany

Location

Study Site

Prien am Chiemsee, Germany

Location

Study Site

Schwedt, Germany

Location

Study Site

Würzburg, Germany

Location

Study Site

Krakow, Poland

Location

Study Site

Lublin, Poland

Location

Study Site

Wroclaw, Poland

Location

Related Publications (2)

• Leger JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Shebl A, Bauhofer A, Zenker O, Merkies IS; PRIMA study investigators. Efficacy and safety of Privigen((R)) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013 Jun;18(2):130-40. doi: 10.1111/jns5.12017.

  PMID: 23781960 RESULT

• Merkies ISJ, Lawo JP, Edelman JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Leger JM; PRIMA trial investigators. Minimum clinically important difference analysis confirms the efficacy of IgPro10 in CIDP: the PRIMA trial. J Peripher Nerv Syst. 2017 Jun;22(2):149-152. doi: 10.1111/jns.12204. No abstract available.

  PMID: 28594116 DERIVED

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: CSL Behring

clinicaltrials@cslbehring.com

Use email contact

Study Officials

• Program Director Clinical R&D

  CSL Behring

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 19, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 25, 2024
• Results First Posted: April 4, 2013

Record last verified: 2024-06

Locations

DE (7); FI (3); PL (3); FR (5); BE (4)