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
- Nipocalimab (drug), Placebo (drug)
- How long the study runs
- Study runs about 74 months (dates as stated)
- About the drug or intervention
- Nipocalimab — drug: Nipocalimab will be administered intravenously. · Placebo — drug: Placebo will be administered intravenously.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 201
- Started
- 2022-09-23
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for polyradiculoneuropathy, chronic inflammatory demyelinating
- • Phase2/Phase3 - 201 participants
- • The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with polyradiculoneuropathy, chronic inflammatory demyelinating
Where?
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust
- • Devon - Royal Devon & Exeter Hospital
- • Glasgow - NHS Greater Glasgow and Clyde
- • London - Royal Free Hospital
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.
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
Treatment history
Treatments you must have had:
- ✓ this score exclusively from the leg disability score
- ✓ (treatment naive)
What the study is looking for
- ✓Adults greater than or equal to (\>=) 18 years of age at the time of consent and as applicable, must also meet the...
- ✓Active disease as determined by CIDP Disease Activity Status (CDAS) score \>= 3
- ✓Other protocol-defined inclusion criteria will apply
Who cannot take part
- ✗Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
- ✗Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- ✗Other protocol-defined exclusion criteria will apply
See the full criteria
Where Is This Study? (5 UK sites)
University Hospitals Birmingham NHS Foundation Trust
Birmingham B15 2TH, United Kingdom
Royal Devon & Exeter Hospital
Devon EX2 5DW, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow G514TF, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2 JF, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
