At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- riliprubart (drug), Placebo (drug), riliprubart (drug), Placebo (drug)
- How long the study runs
- Study runs about 53 months (dates as stated)
- About the drug or intervention
- riliprubart — drug: Pharmaceutical form: Solution Route of administration: IV solution · Placebo — drug: Pharmaceutical form: Solution Route of administration: IV solution · riliprubart — drug: Pharmaceutical form: Solution Route of administration: SC solution · Placebo — drug: Pharmaceutical form: Solution Route of administration: SC solution · IVIg — drug: Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution · Placebo — drug: Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 160
- Started
- 2024-08-21
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chronic inflammatory demyelinating polyneuropathy
- • Phase3 - 160 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic inflammatory demyelinating polyneuropathy
Where?
- • London - Investigational Site Number : 8260007
- • Inverness - Investigational Site Number : 8260003
- • Oxford - Investigational Site Number : 8260001
This is a simplified summary. Always discuss with your doctor before making any decisions.
About 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ responded to IVIg in the past 5 years
- ✓ active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening
- ✓ documented vaccinations against encapsulated bacterial pathogens given within 5 years
- ✓ a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive
What the study is looking for
- ✓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...
- ✓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...
Who cannot take part
- ✗Participants are excluded from the study if any of the following criteria apply:
- ✗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...
- ✗Poorly controlled diabetes
- ✗Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the...
See the full criteria
Where Is This Study? (3 UK sites)
Investigational Site Number : 8260007
London E1 1BB, United Kingdom
Investigational Site Number : 8260003
Inverness IV2 3UJ, United Kingdom
Investigational Site Number : 8260001
Oxford OX3 9DU, United Kingdom
How to Get in Touch
Trial Transparency email recommended (Toll free for US & Canada)
Sponsor contactCONTACT
