Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 2/3NCT05327114
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Phase 2/3 study testing Nipocalimab in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by Janssen Research & Development, LLC at 120 sites in 19 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- What is being tested?
- Nipocalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 120 sitesin 19 countries
- Study dates
- 23 Sep 2022to 27 Nov 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 to be adjudicated by independent committee during screening period
- 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. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score
- Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (>) 20 mg/day and the participant is willing to taper to <=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
- Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3
- Other protocol-defined inclusion criteria will apply
Who cannot join
- 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 or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results
- 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 another cause such as connective tissue disease or systemic lupus erythematosus
- 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 (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Other protocol-defined exclusion criteria will apply
Trial locations and contacts
120 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
120 sites in 19 countries
China19 sites, 17 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
- Recruiting
Xuanwu Hospital ,Capital Medical University
Beijing, 100053
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
- Recruiting
Peking University Third Hospital
Beijing, 100191
- Recruiting
The First Hospital of Jilin University
Changchun, 130021
- Recruiting
The Third Xiangya Hospital of Central Sourth University
Changsha, 410008
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
- Recruiting
Sichuan Provincial Peoples Hospital
Chengdu, 610072
- Recruiting
Chifeng Municipal Hospital
Chifeng, 024000
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, 350001
- Recruiting
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080
- Recruiting
Qilu Hospital of Shandong University
Jinan, 250012
- Completed
Qianfoshan hospital of Shandong Province
Jinan, 250014
- Recruiting
The First Affiliated Hospital of NanChang University
Nanchang, 330006
- Recruiting
Huashan Hospital Fudan University
Shanghai, 200040
- Completed
Tong Ren Hospital Shanghai Jiao Tong University school of medicine
Shanghai, 200336
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, 430023
- Recruiting
Tangdu hospital the Fourth Military Medical
Xi'an, 710032
- Recruiting
Xi 'an GaoXin Hospital
Xi'an, 710075
Japan19 sites, 16 recruiting
- Recruiting
National Hospital Organization Asahikawa Medical Center
Asahikawa, 070-0901
- Recruiting
Institute of Science Tokyo Hospital
Bunkyō City, 113 8519
- Recruiting
Chiba University Hospital
Chiba, 260-8677
- Recruiting
Seirei Hamamatsu General Hospital
Hamamatsu, 430-8558
- Recruiting
Tokai University Hospital
Isehara, 259-1193
- Completed
Kobe City Medical Center General Hospital
Kobe, 650 0047
- Recruiting
National Center of Neurology and Psychiatry
Kodaira-shi, 187-8551
- Recruiting
Saitama Medical Center
Koshigaya, 343-8555
- Recruiting
Kumamoto University Hospital
Kumamoto, 860-8556
- Recruiting
Chubu Rosai Hospital
Nagoya, 455-8530
- Recruiting
Nagoya University Hospital
Nagoya, 466-8560
- Recruiting
Kindai University Hospital
Osaka Sayama Shi, 589 8511
- Recruiting
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
- Completed
Dokkyo Medical University Hospital
Shimotsuga Gun, 321 0293
- Completed
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666
- Recruiting
Tenri Hospital
Tenri, 632-0015
- Recruiting
Ehime University Hospital
Toon-shi, 791-0295
- Recruiting
Toyama University Hospital
Toyama, 930-0194
- Recruiting
Yamaguchi University Hospital
Ube, 755-8505
United States16 sites, 12 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
- Recruiting
Austin Neuromuscular Center
Austin, Texas, 78756
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Completed
Boston Clinical Trials
Boston, Massachusetts, 02111
- Recruiting
IMMUNOe Health and Research Centers
Centennial, Colorado, 80112
- Recruiting
The Neurological Institute, PA
Charlotte, North Carolina, 28204
- Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
- Recruiting
Healthcare Innovations Institute Inc
Coral Springs, Florida, 33067
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
- Completed
Neurology Associates PA
Maitland, Florida, 32751
- Recruiting
ALS Center at the University of Miami
Miami, Florida, 33136
- Recruiting
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
- Completed
The Neurological Institute of New York
New York, New York, 10032
- Recruiting
South Shore Neurologic Associates - Patchogue
Patchogue, New York, 11772
- Completed
Beaumont Hospital Royal Oak
Royal Oak, Michigan, 48073
France9 sites, 9 recruiting
- Recruiting
CHU Bordeaux
Bordeaux, 33000
- Recruiting
Hospices Civils de Lyon HCL
Bron, 69699
- Recruiting
Hopital de Bicetre
Le Kremlin-Bicêtre, 94270
- Recruiting
Hopital de la Timone
Marseille, 13385
- Recruiting
Hopital PASTEUR
Nice, 06000
- Recruiting
CHU Nimes Hopital Caremeau
Nîmes, 30029
- Recruiting
Hopital de la Pitie Salpetriere
Paris, 75013
- Recruiting
Fondation Adolphe de Rothschild Hospital
Paris, 75019
- Recruiting
CHRU Strasbourg
Strasbourg, 67200
Italy9 sites, 9 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico di Catania
Catania, 95123
- Recruiting
Azienda Ospedaliera Universitaria San Martino di Genova
Genova, 16132
- Recruiting
Casa di Cura del Policlinico
Milan, 20144
- Recruiting
Istituto Neurologico Carlo Besta
Milan, 20133
- Recruiting
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, 80131
- Recruiting
Aou San Luigi Gonzaga
Orbassano, 10043
- Recruiting
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
- Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
- Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, 20086
Germany6 sites, 5 recruiting
- Recruiting
Judisches Krankenhaus Berlin
Berlin, 13347
- Recruiting
St. Josef-Hospital, Ruhr-Universität Bochum
Bochum, 44791
- Recruiting
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, 6120
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
- Recruiting
Universitaetsklinikum Leipzig
Leipzig, 4103
- Completed
St Josefs Krankenhaus Potsdam Sanssouci
Potsdam, 14471
Spain6 sites, 6 recruiting
- Recruiting
Hosp. Gral. Univ. de Alicante
Alicante, 03010
- Recruiting
Hosp Univ Vall D Hebron
Barcelona, 8035
- Recruiting
Hosp. Univ. de Basurto
Bilbao, 48013
- Recruiting
Hosp. Univ. Donostia
Donostia / San Sebastian, 20014
- Recruiting
Hosp. Clinico San Carlos
Madrid, 28040
- Recruiting
Hosp. Virgen Macarena
Seville, 41009
United Kingdom5 sites, 4 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
- Recruiting
Royal Devon & Exeter Hospital
Devon, EX2 5DW
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow, G514TF
- Suspended
Royal Free Hospital
London, NW3 2QG
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2 JF
Argentina4 sites, 4 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
- Recruiting
Instituto Fleni
Buenos Aires, C1428AQK
- Recruiting
Hospital Gral Agudos Ignacio Pirovano
Buenos Aires, C1428
- Recruiting
INECO Neurociencias Orono
Rosario, 2900
Greece4 sites, 3 recruiting
- Recruiting
Attikon General Hospital of Athens
Athens, 12462
- Completed
Patras University Hospital
Pátrai, 26504
- Recruiting
Ahepa Hospital Aristotle University of Thessaloniki
Thessaloniki, 54636
- Recruiting
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, 56429
Poland4 sites, 2 recruiting
- Completed
Centrum Medyczne
Chorzów, 41 500
- Completed
Specjalistyczne Gabinety Lekarskie
Krakow, 30 539
- Recruiting
Prywatny Gabinet Lekarski
Lublin, 20 093
- Recruiting
Clinical Research Center sp z o o MEDIC R s k
Poznan, 61 731
Czechia3 sites, 1 recruiting
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
- Completed
Fakultni Nemocnice Ostrava
Ostrava, 708 52
- Completed
Pardubicka krajska nemocnice a s
Pardubice, 53203
Portugal3 sites, 3 recruiting
- Recruiting
Hospital Garcia de Orta
Almada, 2805-267
- Recruiting
Hospital de Braga
Braga, 4710-243
- Recruiting
Centro Hospitalar de Sao Joao Epe
Porto, 4200 319
South Korea3 sites, 2 recruiting
- Recruiting
Kyunghee University Medical Center
Seoul, 02447
- Completed
Konkuk University Medical Center
Seoul, 05030
- Recruiting
Samsung Medical Center
Seoul, 135-710
Taiwan3 sites, 2 recruiting
- Completed
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 88301
- Recruiting
National Taiwan University Hospital
Taipei, 100
- Recruiting
Shin Kong Wu Ho Su Memorial Hospital
Taipei, 111
Australia2 sites
- Completed
The Alfred Hospital
Melbourne, 3004
- Completed
Gold Coast University Hospital
Parkwood, 4215
Colombia2 sites, 2 recruiting
- Recruiting
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, 681004
- Recruiting
Instituto Neurológico de Colombia
Medellín, 50021
Mexico2 sites, 2 recruiting
- Recruiting
i Can Oncology Center
Monterrey, 64710
- Recruiting
Clinical Research Institute S.C.
Tlalnepantla, 54055
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital Ottawa NeuroMuscular Centre
Ottawa, K1N 6N5
About this study
Official title: Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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.
- Being tested
- Nipocalimab, Placebo
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NipocalimabDrug
Also called JNJ-80202135, M281
Nipocalimab will be administered intravenously.
PlaceboDrug
Placebo will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Nipocalimab | Experimental | Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first. Receives: Drug: Nipocalimab |
| Placebo | Placebo comparator | Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage B: Time to First Occurrence of a Relapse Event
Stage B time to first occurrence of a relapse event will be reported.
Measured: Up to 52 weeks
Secondary outcomes (29)
Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
Time to initial confirmed ECI will be reported.
Measured: 12 weeks
Stage A: Percentage of Responders as Determined by ECI
Stage A percentage of responders as determined by ECI will be reported.
Measured: 12 weeks
Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score
Change from Stage A baseline over time in adjusted INCAT disability scale score will be reported. The INCAT disability scale is a clinician-rated assessment that measures activity limitation and degree of functional disability. The INCAT scale is an ordinal scale scored from 0 to 10, with higher scores indicating more disability.
Measured: Baseline to 12 weeks
Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score
Change from Stage A baseline over time in MRC muscle grading scale sum score will be reported. The MRC muscle grading scale is a clinician-rated outcome that provides a strength rating (on a scale from 0 [no visible contraction] to 5 [normal]) in 6 muscles collected bilaterally: deltoid, biceps, wrist extensors, iliopsoas, quadriceps, tibialis anterior. Lower scores indicate greater impairment.
Measured: Baseline to 12 weeks
Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score
Change from Stage A baseline over time in I-RODS centile score will be reported. The I-RODS comprises of 24 items representing common daily activities that address upper and lower limb disability and range in difficulty from very easy to very difficult. Lower scores indicate greater activity and social participation limitations.
Measured: Baseline to 12 weeks
Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
Change from Stage A baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).
Measured: Baseline to 12 weeks
Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
Change from Stage A baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).
Measured: Baseline to 12 weeks
Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline
Time to first adjusted INCAT disability scale score deterioration relative to Stage B baseline will be reported.
Measured: Up to 52 weeks
Stage B: Time to First Switch to Intravenous Immunoglobulin (IVIg) or Other Standard of Care (SoC) as a Result of Investigator-assessed Lack of Efficacy as Confirmed by an Independent RAC Relative to Baseline
Time to first switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent Relapse Adjudication Committee (RAC) relative to Stage B baseline will be reported.
Measured: Up to 52 weeks
Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score
Change from Stage B baseline over time in adjusted INCAT disability score will be reported.
Measured: Up to 52 weeks
Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score
Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score will be reported.
Measured: Up to 52 weeks
Stage B: Change from Baseline Over Time in I-RODS Centile Score
Change from Stage B baseline over time in I-RODS centile score will be reported.
Measured: Up to 52 weeks
Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
Change from Stage B baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).
Measured: Up to 52 weeks
Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
Change from Stage B baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).
Measured: Up to 52 weeks
Stage B: Number of Participants with Binary Response Endpoint Satisfying all 4 Conditions: a) An Improved Adjusted INCAT Disability Score Compared to Baseline; b) Not Relapsing; c) Not Switching to SoC; d) Not Discontinuing Treatment
Number of participants with Binary response endpoint satisfying all 4 conditions: a) an improved adjusted INCAT Disability Score compared to Stage B baseline; b) not relapsing; c) not switching to SoC; d) not discontinuing treatment, will be reported.
Measured: Up to 52 weeks
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Percentage of Participants with Serious Adverse Events (SAEs)
SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Number of Participants with Change in Electrocardiogram (ECG) Values Over Time
Number of participants with change in ECG values over time will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Number of Participants with Change in Vital Signs Values Over Time
Number of participants with change in vital signs values over time will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Number of Participants with Change in Clinical Laboratory Values Over Time
Number of participants with change in clinical laboratory values over time will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Number of Participants with Clinically Significant ECG Abnormalities
Number of participants with clinically significant ECG abnormalities will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Number of Participants with Clinically Significant Vital Signs Abnormalities
Number of participants with clinically significant vital signs abnormalities will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Number of Participants with Clinically Significant Clinical Laboratory Abnormalities
Number of participants with clinically significant clinical laboratory abnormalities will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Percentage of participants with suicidal ideation or suicidal behavior based on the C-SSRS will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention
Serum nipocalimab concentrations over time in participants receiving active study intervention will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab
Number of participants with ADA to Nipocalimab will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Titers of ADA to Nipocalimab
Titers of ADA to nipocalimab will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab
Number of participants with NAb to Nipocalimab will be reported.
Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks
Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time
Change from baseline in total serum IgG concentrations levels over time will be reported.
Measured: Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start23 Sep 2022
- Primary completion14 May 2027 (estimated)
- Study completion27 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327114
- Sponsor's protocol ID
- CR109195
- Other IDs
- 80202135CDP3001, 2021-003234-37, 2023-508425-28-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- Expanded access
- Available