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Tests treatment safety and results for Polyradiculoneuropathy, Chronic Inflammatory...
Official title Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
ClinicalTrials.gov ID: NCT05327114
What this study is testing
What is Nipocalimab?
Nipocalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for polyradiculoneuropathy, chronic inflammatory demyelinating.
Also referred to as JNJ-80202135, M281.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults greater than or equal to (\>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the...
- Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve...
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In...
- Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (\ ) 20 mg/day and...
- Active disease as determined by CIDP Disease Activity Status (CDAS) score \>= 3
You likely can't join if
- Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease)...
- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
- Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or...
- Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with...
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Other protocol-defined exclusion criteria will apply
See the full eligibility criteria
- Adults greater than or equal to (\>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place
- Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis...
- Inflammatory Neuropathy Cause and Treatment (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...
- Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (\ ) 20 mg/day and the participant is willing to taper to \<=20 mg/day during the run-in...
- Active disease as determined by CIDP Disease Activity Status (CDAS) score \>= 3
- Other protocol-defined will apply
- Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological...
- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
- Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from...
- 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)...
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Other protocol-defined exclusion criteria will apply
The study team makes the final eligibility decision.
Where it's taking place
- Centennial, Colorado, United States
- Coral Springs, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Royal Oak, Michigan, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Patchogue, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Austin, Texas, United States
- Milwaukee, Wisconsin, United States
- Buenos Aires, Argentina
- Rosario, Argentina
- Melbourne, Australia
- Parkwood, Australia
- Ottawa, Canada
+ 83 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Centennial, Colorado, United States; Coral Springs, Florida, United States; Maitland, Florida, United States; Miami, Florida, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States and 97 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 ClinicalTrials.gov; the study team decides eligibility.