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Tests treatment safety and results for Chronic Inflammatory Demyelinating Polyneuropathy
Official title A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
ClinicalTrials.gov ID: NCT06290141
What this study is testing
What is riliprubart?
riliprubart is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic inflammatory demyelinating polyneuropathy.
Also referred to as SAR445088.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/Peripheral Nerve Society (PNS) Task Force CIDP...
- Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner...
- Participants must have responded to IVIg in the past 5 years.
- Participant must be on a stable maintenance dosage of IVIg.
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary...
- Sensory CIDP, distal CIDP and focal CIDP variants.
- Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.
- Poorly controlled diabetes
- Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during...
See the full eligibility criteria
Who can join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).
- Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.
- Participants must have responded to IVIg in the past 5 years.
- Participant must be on a stable maintenance dosage of IVIg.
- Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).
- Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN/PNS 2021 CIDP guidelines.
- Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.
- Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening.
- Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention.
- Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant
- Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.
- Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing...
What rules you out
- Participants are excluded from the study if any of the following criteria apply:
- Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic...
- Sensory CIDP, distal CIDP and focal CIDP variants.
- Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.
- Poorly controlled diabetes
- Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to...
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE...
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any...
- Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of...
- Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or...
- Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the...
- Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.
- Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.
- Recent treatment with plasma exchange
- Treatment within 3 months prior to dosing with immunosuppressive/ immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly...
- Prior treatment with riliprubart.
- Recent use of any specific complement system inhibitor (eg, eculizumab).
- Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.
- Prior treatment with B-cell depleting agents such as rituximab within 6 months.
- Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).
- Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening.
- Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.
- Positive result of any of the following tests:
- hepatitis B surface antigen (HbsAg).
- anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies [anti-HBs Ab] are also positive, indicating natural immunity).
- anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained.
- anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.
- Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.
- Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
- Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.
- Recent treatment with efgartigimod. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Orange, California, United States
- Centennial, Colorado, United States
- New Haven, Connecticut, United States
- Bradenton, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Glenview, Illinois, United States
- Kansas City, Kansas, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- East Lansing, Michigan, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Amherst, New York, United States
- New York, New York, United States
+ 95 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homewood, Alabama, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Orange, California, United States; Centennial, Colorado, United States; New Haven, Connecticut, United States and 109 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.