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    Summary
    EudraCT Number:2020-005569-14
    Sponsor's Protocol Code Number:80202135SLE2001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-09
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-005569-14
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus
    A.4.1Sponsor's protocol code number80202135SLE2001
    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+31715242166
    B.5.5Fax number+31715242110
    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 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 nameM281
    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
    Active Systemic Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    Active Systemic Lupus Erythematosus
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of nipocalimab vs placebo in participants with active systemic lupus erythematosus (SLE)
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of nipocalimab vs placebo in participants with active SLE
    2. To evaluate the pharmacokinetics (PK) and immunogenicity of nipocalimab in participants with active SLE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female, 18 to 65 years of age (inclusive) at the time of consent.
    -Has a clinical diagnosis of SLE ≥6 months prior to the screening visit and according to Systemic Lupus International Collaborating Clinics (SLICC)-2012 classification criteria: at least 4 criteria fulfilled, with at least one clinical criterion AND one immunologic criterion.
    -Has at least 1 BILAG A and/or 2 BILAG B scores observed during screening.
    -Must have at least moderately active SLE, as defined as SLEDAI-2K score ≥6 at screening visit. Must also have SLEDAI 2K ≥4 for clinical features (ie, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization.
    -Must be receiving one or more of the following protocol-permitted, systemic standard-of-care treatments:
    a) Oral GCs (average daily dose ≤20 mg of prednisone or equivalent) for ≥6 weeks and at a stable dose ≥4 weeks prior to first administration of study intervention. If currently not using oral GCs, must not have received them for ≥6 weeks prior to the first administration of study intervention.
    b) Antimalarials (≤250 mg/day [3 mg/kg/day] chloroquine, ≤400 mg/day hydroxychloroquine, and/or ≤100 mg/day quinacrine) at a stable dose for ≥12 weeks prior to first administration of study intervention.
    c) If using one or more of the following immunomodulatory drugs, must be on a stable dose for ≥8 weeks prior to first administration of study intervention:
    • Mycophenolate mofetil (MMF) ≤2 g/day
    • Mycophenolic acid (MPA) ≤1.5 g/day
    • Azathioprine (AZA)/6 mercaptopurine (6-MP) ≤2 mg/kg/day; up to 100 mg/day for participants weighing ≤50 kg
    • Oral methotrexate (MTX) ≤25 mg/week or SC or intramuscular (IM) MTX ≤20 mg/week with concomitant folic acid or folinic acid.
    No more than 2 immunomodulatory drugs listed above (MMF, MPA, AZA, 6-MP, MTX) is allowed.
    E.4Principal exclusion criteria
    -Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active LN. Have severe active LN as determined by sponsor (or designee) adjudication.
    -Anticipated to require dialysis within 6 months.
    -Comorbidities (other than SLE, eg, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic GCs within the previous 12 months and likely to require multiple courses of GCs within 6 months.
    -Has any unstable or progressive manifestation of SLE
    -Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis, RA/lupus overlap, psoriasis, Crohn’s disease, or active Lyme disease.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving an SLE Responder Index (SRI)-4 composite response
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    1. Proportion of participants with baseline active mucocutaneous lupus manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] activity score ≥6) achieving ≥50% reduction in the CLASI) activity score
    2. Proportion of participants with baseline arthritis (with at least 4 active joints at baseline) achieving ≥50% reduction in active joints
    3. Proportion of participants with ≥4 point improvement in SLE disease activity index 2000 (SLEDAI-2K)
    4. Proportion of participants achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) response
    5. Time to first flare, with flare defined as either 1 or more new BILAG A or 2 or more new BILAG B scores
    6. Proportion of participants achieving SRI-4 composite response
    7. Proportion of participants receiving ≥10 mg/day prednisone or equivalent at baseline who achieve Week 6 – 16 glucocorticoid (GC) taper goal (at Week 16 to ≤7.5 mg/day prednisone or equivalent) and maintain that reduction
    8. Proportion of participants with treatment emergent adverse events (AEs)
    9. Proportion of participants with treatment emergent serious adverse events (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 24
    2. Week 24
    3. Week 24
    4. Week 24
    5. Week 24
    6. Week 52
    7. Week 24
    8. Through Week 58
    9. Through Week 58
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and tolerability
    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) No
    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 trial3
    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 EEA17
    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
    Colombia
    Hong Kong
    Japan
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    United States
    Bulgaria
    Germany
    Hungary
    Poland
    Spain
    Argentina
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days29
    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: 225
    F.1.3Elderly (>=65 years) No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 225
    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)
    None
    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 Decision2021-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
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