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    Summary
    EudraCT Number:2021-003234-37
    Sponsor's Protocol Code Number:80202135CDP3001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-003234-37
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Study of Nipocalimab for Adults with CIDP
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety Study of Nipocalimab for Adults with CIDP
    A.4.1Sponsor's protocol code number80202135CDP3001
    A.5.4Other Identifiers
    Name:INDNumber:156269
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71524 2166
    B.5.5Fax number+31(0)71524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNipocalimab
    D.3.2Product code M281/JNJ-80202135
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnipocalimab
    D.3.9.1CAS number 2211985-36-1
    D.3.9.2Current sponsor codeJNJ-80202135
    D.3.9.3Other descriptive nameJNJ-80202135
    D.3.9.4EV Substance CodeSUB195356
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Inflammatory Demyelinating Polyneuropathy
    E.1.1.1Medical condition in easily understood language
    Chronic Inflammatory Demyelinating Polyneuropathy
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of nipocalimab compared to placebo in delaying relapse in participants with CIDP who initially respond to nipocalimab in
    Stage A
    E.2.2Secondary objectives of the trial
    Stage A:
    * To assess improvement of symptoms on nipocalimab
    * To assess improvement in disease severity and progression on nipocalimab

    Stage B:
    * To evaluate the efficacy of nipocalimab compared to placebo on time to CIDP disease progression from Stage B baseline
    * To evaluate the efficacy of nipocalimab compared to placebo on improved functional level compared to Stage B baseline

    Other secondary:
    * To assess the safety and tolerability of nipocalimab compared to placebo
    * To assess the PK and immunogenicity of nipocalimab
    * To evaluate the PD of nipocalimab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 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.
    2. 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.
    3. Adjusted INCAT disability score between 2 and 9 (a score of 2 has to be exclusively from leg disability).
    4. Fulfilling any of the following treatment conditions:
    a. Currently treated with pulsed corticosteroids, oral corticosteroids and/or IVIg or SCIg and the patient is willing to discontinue or taper this treatment at the first run-in visit;
    or
    b. Without previous treatment (treatment naïve); or
    Treatment with corticosteroids and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
    5. Active disease as determined by CIDP Disease Activity Status (CDAS) score ≥3.
    6. Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol.
    7. It is recommended to be up to date on all age-appropriate vaccinations prior to screening per routine local medical guidelines. It is strongly recommended that participants will have completed a locally-approved (or emergency use-authorized) COVID-19 vaccination regimen at least 2 weeks prior to study-related visits or procedures. Study participants should follow applicable local vaccine labeling, guidelines, and standards-of-care for patients receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrollment.
    8. A woman of childbearing potential must have a negative highly sensitive serum (b-human
    chorionic gonadotropin [b-hCG]) at Screening and a negative urine pregnancy test at
    Day 1 prior to administration of study intervention.
    9. A woman must be:
    - Not of childbearing potential
    - Of childbearing potential and practicing a highly effective method of contraception while receiving study intervention and until 30 days after last dose-the end of relevant systemic exposure.
    10. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after the administration of study intervention.
    11. A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the
    study and for at least 90 days after receiving the last administration of study intervention. In addition, male participants with partners who are
    a woman of childbearing potential are highly encouraged to inform their partner to use highly effective contraception methods that result in a low
    failure rate (less than 1% per year). See Appendix 6.
    12. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention.
    13. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to
    voluntarily participate in the study and comply with all study procedures. Participants who initially provide consent and subsequently withdraw it
    prior to enrollment in Run-in or Stage A (as applicable as per Inclusion Criteria 4), will be deemed as having failed this inclusion criterion. (Must
    be legal age of consent is the jurisdiction in which the study is taking place, at the time of consent).
    14. Must be able to read and write.
    E.4Principal exclusion criteria
    1. 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.
    2. Pure sensory CIDP or CISP (EAN/PNS definition).
    3. 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.
    4. Any other disease that could better explain the patient'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.
    5. Any history of myelopathy or evidence of central demyelination.
    6. Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell
    carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months
    [defined as a minimum of 12 weeks] before the first study intervention administration or cervical carcinoma in situ that has been treated with
    no evidence of recurrence for at least 3 months before the first study intervention administration).
    7. Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients.
    8. Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (eg, mAbs).
    9. Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening.
    10. History of moderate or severe substance or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th
    edition) (DSM-5) criteria, except nicotine or caffeine, within 1 year before screening.
    11. Is (anatomically or functionally) asplenic.
    12. Is currently breastfeeding, pregnant, intends to become pregnant during the study, or is planning egg donation during the study or within
    30 days after the last dose of study intervention.
    13. Is planning to father a child while enrolled in this study or within 90 days after the last dose of study intervention.
    14. Treatment with the following:
    - Within 3 months (or 5 half-lives of the drug, whichever is longer) before screening: plasma exchange or immunoadsorption, any
    concomitant Fccontaining therapeutic agents (including factor or enzyme replacement) or other biological, or any other investigational product.
    - Within 6 months before screening: rituximab, alemtuzumab, any other monoclonal antibody, cyclophosphamide, interferon, tumor necrosis
    factor-alpha inhibitors, fingolimod, methotrexate, azathioprine, mycophenolate, and any other immunomodulating or immunosuppressive medications.
    Note: Inhaled, intra-articular, topical or ocular corticosteroids are not exclusionary.
    - Has previously received nipocalimab.
    15. Has received, or is expected to receive, a live vaccine within 4 weeks prior to screening or has a known need to receive a live vaccine during
    the study or within 8 weeks after the last administration of study intervention in this study. Participants are allowed to receive a vaccine
    conditionally approved SARS-CoV-2, unless it is a live vaccine. Concomitant enrollment in an investigational study for any SARS-CoV-2
    (COVID-19) vaccine while participating in this study is not permitted.
    16. Has had a Bacille Calmette-Guérin (BCG) vaccination within 1 year of first administration of study intervention..
    (For additional criteria, please see protocol)
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of a relapse event, where relapse is defined by the deterioration in either adjusted INCAT disability score relative to Stage B baseline or the switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent RAC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage B
    E.5.2Secondary end point(s)
    * Time to initial confirmed ECI
    * Percentage of responders as determined by ECI
    * Change from Stage A baseline over time in adjusted INCAT disability score
    * Change from Stage A baseline over time in MRC Muscle Grading Scale Sum score
    * Change from Stage A baseline over time in I-RODS centile score
    * Change from Stage A baseline over time in mean grip strength (dominant hand)
    * Change from Stage A baseline over time in mean grip strength (non-dominant hand)

    * Time to first adjusted INCAT disability score deterioration relative to Stage B baseline
    * Time to first switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent RAC relative to Stage B baseline
    * Change from Stage B baseline over time in adjusted INCAT disability score
    * Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score
    * Change from Stage B baseline over time in I-RODS centile score
    * Change from Stage B baseline over time in mean grip strength (dominant hand)
    * Change from Stage B baseline over time in mean grip strength (non-dominant hand)
    * Binary response endpoint satisfying all 4 conditions: (1) an improved adjusted INCAT disability score compared
    to Stage B baseline, (2) not relapsing, (3) not switching to SoC, (4) not discontinuing treatment

    * Percentage of participants with TEAEs and SAEs
    * Change in ECG, vital signs and clinical laboratory values over time
    * Incidence of clinically significant ECG, vital signs and clinical laboratory abnormalities
    * Percentage of participants with suicidal ideation or suicidal behavior based on the C-SSRS

    * Serum nipocalimab concentrations over time in participants receiving active study intervention
    * Incidence and titers of ADA to nipocalimab and the presence of NAb to nipocalimab
    * Changes in total serum IgG concentrations over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    See protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Colombia
    Switzerland
    Taiwan
    Australia
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Mexico
    Turkey
    United Kingdom
    United States
    Austria
    Belgium
    Czechia
    Denmark
    France
    Germany
    Greece
    Italy
    Poland
    Portugal
    Slovakia
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Local regulations on continued access will always take precedence.
    Plans for continued access stated in the protocol may change if new
    information on the benefit-risk profile of nipocalimab becomes
    available during the study or program.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-05
    P. End of Trial
    P.End of Trial StatusOngoing
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