A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyeli… (NCT06290128) | Clinical Trial Compass
RecruitingPhase 3
A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work
United States140 participantsStarted 2024-07-12
Plain-language summary
The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 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 two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee.
* Participant must be refractory to either immunoglobulin therapy or corticosteroid therapy, as defined below.
* Immunoglobulin-refractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening
* Corticosteroid-refractory subgroup: Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening
* Participant has an INCAT score of 2 to 9
* Any allowed immunosuppressant drugs (azathioprine, cyclosporine, or mycophenolate mofetil) have been taken for ≥6 months
* Participant may be receiving low-dose oral corticosteroids (≤20 mg/day of prednisone or equivalent)
* 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
* Contrace…
What they're measuring
1
Percentage of participants experiencing a response
Timeframe: Baseline to week 24
2
Percentage of participants randomized to riliprubart with lasting response
Timeframe: Baseline to week 48
3
Percentage of participants randomized to placebo who experience a response
Timeframe: Week 24 to week 48
Trial details
NCT IDNCT06290128
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-05-17
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)