Efficacy and Safety Study of Nipocalimab for Adults with CIDP
EU CTIS ID: 2023-508425-28-00
What this study is testing
To evaluate the efficacy of nipocalimab compared to placebo in delaying relapse in participants with CIDP who initially respond to nipocalimab in Stage A
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults ≥18 years of age at the time of consent and as applicable, must also meet the legal age of consent and in the jurisdiction in which the study is taking place.
- Diagnosed with CIDP according to criteria of the EAN/PNS 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period.
- INCAT disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score.
You likely can't join if
- Has a history of severe and/or uncontrolled hepatic (e.g. viral/alcoholic/ autoimmune hepatitis/cirrhosis and or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/ or any other medical or uncontrolled autoimmune disorder(s) (e.g. diabetes mellitus) or clinically significant abnormalities in screening laboratory that might interfere with the patient's full participation in the study, or might jeopardize the safety of the participant or the validity of the study results. Note: Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participants (e.g., compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Pure sensory CIDP or CISP (EAN/PNS definition).
- Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy. Note: A concomitant polyneuropathy of other causes (e.g. a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if CIDP is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Taiwan
- Colombia
- Brazil
- Korea, Republic of
- Canada
- United Kingdom
- Australia
- Mexico
- Argentina
- Japan
- Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Taiwan; Colombia; Brazil; Korea, Republic of; Canada and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.