A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous… (NCT06290141) | Clinical Trial Compass
RecruitingPhase 3
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)
United States160 participantsStarted 2024-08-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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.
* Contracept…
What they're measuring
1
Percentage of participants experiencing a response
Timeframe: Baseline to week 24
2
Percentage of participants randomized to riliprubart who responded during part A and had a lasting response during the open-label treatment extension period
Timeframe: Baseline to week 48
Trial details
NCT IDNCT06290141
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-07-09
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)