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)
- Conditions
- Chronic Inflammatory Demyelinating PolyneuropathyMedDRA version: 20.0Level: LLTClassification code: 10077384Term: Chronic inflammatory demyelinating polyneuropathy Class: 10029205Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-508338-33-00
- Lead Sponsor
- Sanofi-Aventis Recherche & Developpement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 229
Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripherial Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021)., Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN/PNS 2021 CIDP guidelines: 0.4 to 1 g/kg every 2 to 6 weeks., 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 of Screening or initiated a minimum of 14 days prior to first dose of study intervention., 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, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records., All participants must agree to use contraception methods during and after the study as required., Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies., -A male participant is eligible to participate if they agree to the following during the study intervention period and for at least 55 weeks after the last dose of study medication. --Refrain from donating or cryopreserving sperm. PLUS, either: --Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR --Must agree to use contraception/barrier as detailed below: -A male condom and an additional highly effective contraceptive method (Contraceptive and barrier guidance per protocol) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant., -A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: --Is a woman of nonchildbearing potential (WONCBP) as defined by the protocol. OR --Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, as described in the protocol during the study intervention period (to be effective before starting the intervention) and for at least 55 weeks after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period., 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. Response must be an objective clinically meaningful improvement defined by at least one of the following: =1 point decrease in adjusted INCAT score, =4 points increase in I-RODS centile score, =3 points increase in the MRC-SS, =8 kilopascal improvement
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 disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy., 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 participant is at risk for a suicide attempt., 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., Treatment with plasma exchange within 8 weeks prior to Screening., Treatment within 3 months prior to dosing with immunosuppressive/ immunomodulator medication, or corticosteroids (except =20 mg/day of prednisone or equivalent which is allowed), or prior treatment (at any time) with highly immunosuppressive/ chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine)., Prior treatment with riliprubart., Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer, prior to Screening., 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 prior to riliprubart dosing, or before B-cell counts return to normal levels, whichever is longer., Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening)., Sensory CIDP, distal CIDP and focal CIDP variants., -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: --HBsAg. --Anti-HBc Ab; unless anti-HBs Ab are also positive, indicating natural immunity. --Anti-HCV antibodies. --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., Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments., Poorly controlled diabetes (HbA1c >7%)., Serious infections requiring hospita
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method