Riliprubart vs IVIg for CIDP

(VITALIZE Trial)

Recruiting at 94 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must be taking: IVIg

Must not be taking: Immunosuppressants, Corticosteroids, Chemotherapy, others

Disqualifiers: Diabetes, Infections, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

160 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable maintenance dosage of IVIg (a type of medication) and does not specify stopping other medications. However, certain treatments like plasma exchange, immunosuppressive medications, and specific complement system inhibitors must not have been used recently. It's best to discuss your current medications with the study team to ensure eligibility.

How is the drug Riliprubart different from other treatments for CIDP?

Riliprubart is a novel treatment for CIDP that may offer a different mechanism of action compared to traditional immunoglobulin therapies like IVIg, which are commonly used but have varying effectiveness and require ongoing maintenance. While IVIg is administered intravenously, Riliprubart's unique approach could potentially address some of the limitations and burdens associated with current CIDP treatments. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who have responded to IVIg treatment in the past. They must meet specific diagnostic criteria, have a stable dose of IVIg, and some ongoing disability from CIDP. Vaccinations against certain bacteria are required, and participants must agree to use contraception.

Inclusion Criteria

I am willing to switch my IVIg infusions to a hospital setting before the study starts.

I agree to use birth control during and after the study as required.

My IVIg dose has been stable for the last 8 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Riliprubart + Placebo IVIg or IVIg + Placebo Riliprubart for 24 weeks

24 weeks

Open-label extension

Participants receive Riliprubart for an additional 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Riliprubart

Trial Overview The study tests Riliprubart's effectiveness compared to standard IVIg treatment in managing CIDP symptoms over up to 109 weeks. Participants will be randomly assigned either the new drug or usual treatment and monitored for changes in their condition.

Participant Groups

Group I: Riliprubart Arm Experimental Treatment 2 Interventions

Riliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks

Group II: IVIg Arm Active Control 3 Interventions

IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks

Riliprubart is already approved in China, European Union for the following indications:

Approved in China as Riliprubart for:

• Chronic inflammatory demyelinating polyneuropathy (CIDP) - Breakthrough Therapy status

Approved in European Union as Riliprubart for:

• Chronic inflammatory demyelinating polyneuropathy (CIDP) - Orphan Drug status

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Findings from Research

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients often start treatment with intravenous immunoglobulin (IVIg) at a standard dose of 2 g/kg, but most require ongoing maintenance therapy due to limited sustained improvement.

There is significant variability in IVIg maintenance regimens among doctors, and the lack of evidence-based guidelines may lead to either under- or overtreatment, highlighting the need for standardized protocols to optimize therapy for CIDP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance IV immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy. Kuitwaard, K., Fokkink, WR., Brusse, E., et al.[2018]

In a pivotal phase III trial, maintenance therapy with subcutaneous immunoglobulin (IgPro20) for 24 weeks significantly reduced relapse rates in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) compared to placebo, demonstrating its efficacy as a treatment option.

IgPro20 was well tolerated with low rates of systemic adverse events, and over half of the patients preferred it over their previous intravenous immunoglobulin (IVIg) therapy, indicating it may be a more convenient and safer alternative for long-term management of CIDP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Globulin Subcutaneous (Human) 20% (Hizentra®): A Review in Chronic Inflammatory Demyelinating Polyneuropathy. Lamb, YN., Syed, YY., Dhillon, S.[2022]

In a study involving 41 patients with chronic inflammatory demyelinating polyneuropathy (CIDP), switching from intravenous immunoglobulin (IVIg) to an equivalent dose of subcutaneous immunoglobulin (IgPro20) maintained stability in clinical outcomes such as disability and muscle strength over 6 months.

A significant 88% of patients preferred the subcutaneous IgPro20 treatment over IVIg after the switch, indicating not only efficacy but also improved patient satisfaction with the new treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switch from intravenous to subcutaneous immunoglobulin IgPro20 in CIDP patients: a prospective observational study under real-world conditions. Gingele, S., Koch, M., Saparilla, AC., et al.[2022]

Hizentra, a subcutaneous immunoglobulin therapy, offers significant cost savings of approximately $32,447 per patient annually compared to intravenous immunoglobulin (IVIG) for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

The analysis suggests that switching 10% of patients from IVIG to Hizentra could save a hypothetical 25-million-member health plan about $2.3 million, highlighting Hizentra's economic advantages and reduced patient burden due to self-administration and fewer adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Budget Impact Model of Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy with IgPro20 (Hizentra) Relative to Intravenous Immunoglobulin in the United States. Mallick, R., Carlton, R., Van Stiphout, J.[2023]

In a study of 41 patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), intravenous immunoglobulin (IVIg) was found to be more effective than intravenous methylprednisolone (IVMP), with 87.5% of IVIg patients improving compared to 54.2% of IVMP patients.

While both treatments had a high rate of relapse after discontinuation (85.7% for IVIg and 76.9% for IVMP), the median time to relapse was significantly longer for IVMP (14 months) compared to IVIg (4.5 months), suggesting that IVMP may provide a longer duration of benefit despite a lower initial response rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and time to relapse after discontinuing 6-month therapy with IVIg or pulsed methylprednisolone in CIDP. Nobile-Orazio, E., Cocito, D., Jann, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Maintenance IV immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Immune Globulin Subcutaneous (Human) 20% (Hizentra®): A Review in Chronic Inflammatory Demyelinating Polyneuropathy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Switch from intravenous to subcutaneous immunoglobulin IgPro20 in CIDP patients: a prospective observational study under real-world conditions. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Budget Impact Model of Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy with IgPro20 (Hizentra) Relative to Intravenous Immunoglobulin in the United States. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Frequency and time to relapse after discontinuing 6-month therapy with IVIg or pulsed methylprednisolone in CIDP. [2022]