Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44376   clinical trials with a EudraCT protocol, of which   7389   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2020-005569-14
    Trial protocol
    		 HU   PL   ES   BG  
    Global end of trial date
    25 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jan 2026
    First version publication date
    23 Jan 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    80202135SLE2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04882878
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Dec 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the efficacy and safety of nipocalimab vs placebo in participants with active systemic lupus erythematosus (SLE).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 Protocol permitted standard of care therapies.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 52
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Colombia: 33
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Taiwan: 9
    Country: Number of subjects enrolled
    Ukraine: 6
    Country: Number of subjects enrolled
    United States: 39
    Country: Number of subjects enrolled
    South Africa: 21
    Worldwide total number of subjects
    228
    EEA total number of subjects
    60
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    225
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 228 participants were randomized and treated in the study. Out of 228, 192 participants completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive placebo matching to nipocalimab as an intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo matching to nipocalimab as an IV infusion q2w through Week 50.

    Arm title
    		 Nipocalimab 5 mg/kg IV
    Arm description
    		 Participants with active, autoantibody-positive SLE who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive nipocalimab 5 milligrams per kilogram (mg/kg) as an IV infusion q2w from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    JNJ-80202135
    Other name
    M281
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received nipocalimab 5 mg/kg as an IV infusion q2w through Week 50.

    Arm title
    		 Nipocalimab 15 mg/kg IV
    Arm description
    		 Participants with active, autoantibody-positive SLE who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive nipocalimab 15 mg/kg as an IV infusion q2w from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    JNJ-80202135
    Other name
    M281
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received nipocalimab 15 mg/kg as an IV infusion q2w through Week 50.

    Number of subjects in period 1
    		Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Started
    75
    77
    76
    Completed
    60
    65
    67
    Not completed
    15
    12
    9
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    9
    4
    4
         Unspecified
    5
    6
    3
         Lost to follow-up
    1
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive placebo matching to nipocalimab as an intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Reporting group title
    Nipocalimab 5 mg/kg IV
    Reporting group description
    		 Participants with active, autoantibody-positive SLE who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive nipocalimab 5 milligrams per kilogram (mg/kg) as an IV infusion q2w from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Reporting group title
    Nipocalimab 15 mg/kg IV
    Reporting group description
    		 Participants with active, autoantibody-positive SLE who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive nipocalimab 15 mg/kg as an IV infusion q2w from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Reporting group values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV Total
    Number of subjects
    		 75 77 76 228
    Age categorical
    Units: Subjects
        In Utero
    		 0 0 0 0
        Preterm newborn infants (gestional age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days - 23 months)
    		 0 0 0 0
        Children (2 - 11 years)
    		 0 0 0 0
        12 - 17 years
    		 0 0 0 0
        Adults (18 - 64 years)
    		 75 76 74 225
        From 65 - 84 years
    		 0 1 2 3
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.3 ( 11.35 ) 41.1 ( 11.82 ) 43.9 ( 11.85 ) -
    Gender categorical
    Units: Subjects
        Male
    		 4 4 4 12
        Female
    		 71 73 72 216

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive placebo matching to nipocalimab as an intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Reporting group title
    Nipocalimab 5 mg/kg IV
    Reporting group description
    		 Participants with active, autoantibody-positive SLE who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive nipocalimab 5 milligrams per kilogram (mg/kg) as an IV infusion q2w from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Reporting group title
    Nipocalimab 15 mg/kg IV
    Reporting group description
    		 Participants with active, autoantibody-positive SLE who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive nipocalimab 15 mg/kg as an IV infusion q2w from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Primary: Percentage of Participants who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24

    		 Close Top of page
    End point title
    		 Percentage of Participants who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
    End point description
    SRI-4 measures reduction in SLE disease activity and was composite measure that included SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) and Physician Global Assessment (PGA). SRI-4 response: >=4-point reduction from baseline (BL) in SLEDAI-2K score, no new BILAG A or >1 new BILAG B (score A: severe disease; B: moderate disease), and no worsening in PGA (PGA <10% increase from BL). Composite response: SRI-4 response in participants who did not meet treatment failure criteria. SLEDAI-2K: assesses improvement in disease activity (ranged:0-105; higher score=higher severity). BILAG: assesses disease extent, severity (A[severe]-E[no disease]). PGA: assesses worsening in participant's health, recorded on visual analogue scale (VAS) with responses for disease activity ranged 0(none)-3(severe); higher score=higher disease activity. Full analysis set (FAS): all randomized participants who received at least 1 dose (partial/complete) of any study intervention.
    End point type
    Primary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    75
    77
    76
    Units: Percentage of participants
        number (confidence interval 90%)
    46.7 (37.2 to 56.1)
    49.4 (39.9 to 58.9)
    53.5 (44.1 to 63.0)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Nipocalimab 5 mg/kg IV v Placebo
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.331
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.1
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.081
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 2.9

    Secondary: Percentage of Participants With Baseline Active Mucocutaneous Lupus Manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] Activity Score >=6) Achieving >=50% Reduction in CLASI Activity Score at Week 24

    		 Close Top of page
    End point title
    		 Percentage of Participants With Baseline Active Mucocutaneous Lupus Manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] Activity Score >=6) Achieving >=50% Reduction in CLASI Activity Score at Week 24
    End point description
    Percentage of participants with baseline active mucocutaneous lupus manifestations (CLASI activity score >=6) achieving >=50% reduction in CLASI activity score at Week 24 was reported. CLASI assess disease activity and damage caused to skin for cutaneous lupus erythematosus patients with/without systemic involvement across 13 body areas. CLASI consisted of 2 scores; (1) Activity Score (ranged: 0-70) (2) Damage Score (ranged: 0-56). Activity was scored by the investigator based on erythema (0-3 per area), scale/hyperkeratosis (0-2 per area), mucous membrane involvement (0-1), acute hair loss (0-1) and non-scarring alopecia (0-3). Damage was scored in terms of dyspigmentation (0-2 per area), scarring (0-2 per area), scarring alopecia (3 points if present), deep scarring (1 point). Scores were calculated by addition based on the extent of symptoms. Higher scores=worse disease activity. FAS used. N (overall number of participants analyzed)=participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    41
    43
    40
    Units: Percentage of participants
        number (confidence interval 90%)
    46.3 (33.5 to 59.2)
    53.2 (40.4 to 66.1)
    53.8 (40.7 to 66.9)
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.247
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 3.1
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.09
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 4.5

    Secondary: Percentage of Participants With Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving Greater Than or Equal to (>=) 50% Reduction in Active Joints at Week 24

    		 Close Top of page
    End point title
    		 Percentage of Participants With Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving Greater Than or Equal to (>=) 50% Reduction in Active Joints at Week 24
    End point description
    The active joint was defined as a joint that was painful as reported by the participant and demonstrated tenderness and at least one additional sign of inflammation (for example [e.g.]: observed swelling such as edema or effusion) on physical examination as determined by the joint assessor. Each of 64 joints would be evaluated for symptoms of pain, tenderness and 62 joints for swelling or effusion (hips are excluded). 50% reduction in active joints: Participants with baseline arthritis who had >=50% reduction in active joints from baseline. FAS: all randomized participants who received at least 1 dose (partial or complete) of any study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    68
    72
    69
    Units: Percentage of participants
        number (confidence interval 90%)
    75.0 (66.4 to 83.6)
    82.0 (74.4 to 89.6)
    75.4 (66.8 to 83.9)
    Statistical analysis title
    		 Statistical Analysis 5
    Comparison groups
    Placebo v Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.122
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 3.7
    Statistical analysis title
    		 Statistical Analysis 6
    Comparison groups
    Placebo v Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.296
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 2.6

    Secondary: Percentage of Participants With >=4 Point Improvement From Baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24

    		 Close Top of page
    End point title
    		 Percentage of Participants With >=4 Point Improvement From Baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24
    End point description
    SLEDAI-2K was a validated SLE activity index, based on the presence of 24 features in 9 organ systems and measures disease activity in SLE patients at the time of visit or in previous 30 days; the index was weighted according to the feature. Features were scored by assessing physician if present at the time of visit or within last 30 days, with more severe features having higher scores, and added to determine total SLEDAI-2K score, ranged: 0-105; higher scores=increased disease activity. Baseline measurement for SLEDAI-2K was defined as the closest measurement taken prior to initiation of the Week 0 study intervention administration. SLEDAI improvement was defined as a reduction from baseline in total SLEDAI-2K score. No worsening of total SLEDAI-2K from baseline was defined as a change <=0 in SLEDAI-2K score and meaningful improvement was defined as a reduction in SLEDAI-2K of 4 or more. FAS used. 'N' (overall number of participants analyzed)=participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    75
    77
    75
    Units: Percentage of participants
        number (confidence interval 90%)
    46.7 (37.2 to 56.1)
    49.3 (39.8 to 58.8)
    54.3 (44.7 to 63.8)
    Statistical analysis title
    		 Statistical Analysis 8
    Comparison groups
    Placebo v Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.069
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 3
    Statistical analysis title
    		 Statistical Analysis 7
    Comparison groups
    Placebo v Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.338
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.1

    Secondary: Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24

    		 Close Top of page
    End point title
    		 Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24
    End point description
    The BILAG-based Composite Lupus Assessment (BICLA) was a composite index to assess disease activity in SLE. BICLA response defined as: (1) Reduction of all baseline (BL) BILAG-2004 A to B/C/D and BL BILAG-2004 B to C/D and no BILAG-2004 worsening in other organ systems, defined by >=1 new BILAG-2004 A or >=2 new BILAG-2004 B (Score A: Severely active disease; B: Moderately active disease; C: Mild stable disease; D: Inactive now but previously active; E: Never affected). (2) No worsening from BL in SLEDAI-2K: increase from BL of >0 points in SLEDAI-2K. Increase from BL corresponds to change from BL. (3) No worsening from BL in participants’ lupus disease activity defined by increase >=0.30 points on 3-point PGA VAS. (4) No discontinuation of study intervention or use of rescue medication beyond protocol-allowed threshold before assessment. If any of the conditions cannot be evaluated at Week 24 (due to missing values) the participant was defined as BICLA non-responder. FAS was used.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    75
    77
    76
    Units: Percentage of participants
        number (confidence interval 90%)
    32.0 (23.1 to 40.9)
    39.3 (30.0 to 48.6)
    36.1 (27.0 to 45.2)
    Statistical analysis title
    		 Statistical Analysis 9
    Comparison groups
    Placebo v Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.211
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.4
    Statistical analysis title
    		 Statistical Analysis 10
    Comparison groups
    Placebo v Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.242
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.3

    Secondary: Time to First Flare Through Week 24

    		 Close Top of page
    End point title
    		 Time to First Flare Through Week 24
    End point description
    Time to first flare: Time to first occurrence of a flare. Flare was defined as at least 1 new BILAG A item score or at least 2 new BILAG B item scores meeting at least 1 of following criteria: 1) Not present at baseline, 2) The occurrence of a new/worse manifestation in a different component of an organ system that is already present, 3) at least 1 A or 2 B scores in an organ system which improves to B/C/D for at least 2 sequential study visits followed by new/worse disease activity. Here, score A: Severely active disease; B: Moderately active disease; C: Mild stable disease; D: Inactive now but previously active; E: Never affected. BILAG flare was based on adjudicated flare. FAS: all randomized participants who received at least 1 dose (partial or complete) of any study intervention. 99999 signifies that median, lower and upper limit of confidence interval could not be calculated due to low number of participants with event.
    End point type
    Secondary
    End point timeframe
    From Week 0 up to Week 24
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    75
    77
    76
    Units: Days
        median (confidence interval 90%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Statistical Analysis 11
    Comparison groups
    Placebo v Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.459
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.69
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.44
    Statistical analysis title
    		 Statistical Analysis 12
    Statistical analysis description
    NA
    Comparison groups
    Placebo v Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.769
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.92

    Secondary: Percentage of Participants who Achieved SRI-4 Composite Response at Week 52

    		 Close Top of page
    End point title
    		 Percentage of Participants who Achieved SRI-4 Composite Response at Week 52
    End point description
    SRI-4 measures reduction in SLE disease activity and was a composite measure that included the SLEDAI-2K, BILAG and PGA. SRI-4 response was defined as >=4-point reduction from baseline in SLEDAI-2K score, no new BILAG A or >1 new BILAG B, and no worsening in the PGA (PGA less than [<] 10% increase from baseline). Composite response was defined as SRI-4 response in participants who did not meet treatment failure criteria. SLEDAI-2K: assesses improvement in disease activity (ranged: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E[no disease]). PGA: assesses worsening in participant's general health , recorded on a VAS with responses for disease activity ranging from 0 (none) to 3 (severe); higher score = higher disease activity. Modified full analysis set (mFAS) included all randomized participants, excluding those from Argentinian site W02-AR10008, who received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    73
    74
    74
    Units: Percentage of participants
        number (confidence interval 90%)
    39.7 (30.3 to 49.1)
    51.7 (42.1 to 61.4)
    53.6 (44.0 to 63.2)
    Statistical analysis title
    		 Statistical Analysis 14
    Comparison groups
    Placebo v Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 3.9
    Statistical analysis title
    		 Statistical Analysis 13
    Comparison groups
    Placebo v Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.054
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 3.3

    Secondary: Percentage of Participants Receiving >=10 milligram/day (mg/day) Prednisone or Equivalent at Baseline who Achieved Week 6-16 Glucocorticoid (GC) Taper Goal (at Week 16 to <=7.5 mg/day Prednisone or Equivalent) and Maintained that Reduction Until Week 24

    		 Close Top of page
    End point title
    		 Percentage of Participants Receiving >=10 milligram/day (mg/day) Prednisone or Equivalent at Baseline who Achieved Week 6-16 Glucocorticoid (GC) Taper Goal (at Week 16 to <=7.5 mg/day Prednisone or Equivalent) and Maintained that Reduction Until Week 24
    End point description
    Sustained (maintained) reduction was defined as achieving Week 6–16 GC taper goal (at Week 16 to less than or equal to [<=] 7.5 mg/day prednisone or equivalent) and maintaining that reduction until Week 24. FAS included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    33
    36
    32
    Units: Percentage of participants
        number (confidence interval 90%)
    69.7 (56.5 to 82.9)
    67.4 (54.2 to 80.6)
    80.8 (69.2 to 92.4)
    Statistical analysis title
    		 Statistical Analysis 16
    Comparison groups
    Placebo v Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.135
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 6.5
    Statistical analysis title
    		 Statistical Analysis 15
    Comparison groups
    Placebo v Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.718
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 1.9

    Secondary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through Week 58

    		 Close Top of page
    End point title
    		 Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through Week 58
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after the initial administration of study intervention. TEAEs included both serious and non-serious AEs. Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    From start of treatment (Week 0) up to Week 58
    End point values
    		 Placebo Nipocalimab 5 mg/kg IV Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    75
    77
    76
    Units: Percentage of participants
    number (not applicable)
        TEAEs
    76.0
    89.6
    82.9
        TESAEs
    8.0
    7.8
    13.2
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From start of treatment (Week 0) up to Week 58
    Adverse event reporting additional description
    Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive placebo matching to nipocalimab as an intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Reporting group title
    Nipocalimab 15 mg/kg IV
    Reporting group description
    		 Participants with active, autoantibody-positive SLE who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive nipocalimab 15 mg/kg as an IV infusion q2w from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Reporting group title
    Nipocalimab 5 mg/kg IV
    Reporting group description
    		 Participants with active, autoantibody-positive SLE who had an inadequate response to one or more standard-of-care treatments (immunomodulators, antimalarial drugs, and glucocorticoids) were randomized to receive nipocalimab 5 milligrams per kilogram (mg/kg) as an IV infusion q2w from Week 0 through Week 50 along with ongoing standard-of-care treatments. Participants were then followed up for safety up to Week 58.

    Serious adverse events
    		 Placebo Nipocalimab 15 mg/kg IV Nipocalimab 5 mg/kg IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 75 (8.00%)
    10 / 76 (13.16%)
    6 / 77 (7.79%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid Haemorrhage
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic Pregnancy
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal Obstruction
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis Alcoholic
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine Enlargement
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Shrinking Lung Syndrome
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot Deformity
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic Lupus Erythematosus
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parametritis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Wound Infection
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Nipocalimab 15 mg/kg IV Nipocalimab 5 mg/kg IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 75 (54.67%)
    51 / 76 (67.11%)
    53 / 77 (68.83%)
    Injury, poisoning and procedural complications
    Limb Injury
         subjects affected / exposed
    3 / 75 (4.00%)
    0 / 76 (0.00%)
    5 / 77 (6.49%)
         occurrences all number
    3
    0
    5
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 75 (5.33%)
    4 / 76 (5.26%)
    5 / 77 (6.49%)
         occurrences all number
    5
    4
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 75 (6.67%)
    6 / 76 (7.89%)
    11 / 77 (14.29%)
         occurrences all number
    5
    7
    11
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 76 (2.63%)
    4 / 77 (5.19%)
         occurrences all number
    10
    2
    5
    Oedema Peripheral
         subjects affected / exposed
    0 / 75 (0.00%)
    5 / 76 (6.58%)
    1 / 77 (1.30%)
         occurrences all number
    0
    5
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 75 (8.00%)
    4 / 76 (5.26%)
    3 / 77 (3.90%)
         occurrences all number
    9
    4
    5
    Abdominal Pain
         subjects affected / exposed
    2 / 75 (2.67%)
    4 / 76 (5.26%)
    1 / 77 (1.30%)
         occurrences all number
    2
    5
    1
    Nausea
         subjects affected / exposed
    4 / 75 (5.33%)
    4 / 76 (5.26%)
    8 / 77 (10.39%)
         occurrences all number
    4
    11
    11
    Vomiting
         subjects affected / exposed
    2 / 75 (2.67%)
    3 / 76 (3.95%)
    4 / 77 (5.19%)
         occurrences all number
    3
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 75 (2.67%)
    4 / 76 (5.26%)
    0 / 77 (0.00%)
         occurrences all number
    2
    4
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    2 / 75 (2.67%)
    7 / 76 (9.21%)
    5 / 77 (6.49%)
         occurrences all number
    7
    9
    8
    Infections and infestations
    Asymptomatic Bacteriuria
         subjects affected / exposed
    1 / 75 (1.33%)
    4 / 76 (5.26%)
    5 / 77 (6.49%)
         occurrences all number
    1
    5
    9
    Covid-19
         subjects affected / exposed
    4 / 75 (5.33%)
    5 / 76 (6.58%)
    5 / 77 (6.49%)
         occurrences all number
    4
    6
    5
    Cystitis
         subjects affected / exposed
    0 / 75 (0.00%)
    4 / 76 (5.26%)
    1 / 77 (1.30%)
         occurrences all number
    0
    8
    1
    Gastroenteritis
         subjects affected / exposed
    4 / 75 (5.33%)
    1 / 76 (1.32%)
    4 / 77 (5.19%)
         occurrences all number
    5
    1
    4
    Gastroenteritis Viral
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 76 (2.63%)
    2 / 77 (2.60%)
         occurrences all number
    4
    2
    3
    Urinary Tract Infection
         subjects affected / exposed
    6 / 75 (8.00%)
    10 / 76 (13.16%)
    6 / 77 (7.79%)
         occurrences all number
    9
    14
    7
    Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 75 (6.67%)
    6 / 76 (7.89%)
    5 / 77 (6.49%)
         occurrences all number
    7
    7
    5
    Pharyngitis
         subjects affected / exposed
    6 / 75 (8.00%)
    3 / 76 (3.95%)
    2 / 77 (2.60%)
         occurrences all number
    8
    3
    3
    Nasopharyngitis
         subjects affected / exposed
    9 / 75 (12.00%)
    10 / 76 (13.16%)
    10 / 77 (12.99%)
         occurrences all number
    10
    11
    12
    Influenza
         subjects affected / exposed
    2 / 75 (2.67%)
    3 / 76 (3.95%)
    6 / 77 (7.79%)
         occurrences all number
    3
    3
    7

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 May 2021
    The overall rationale for the amendment was to include additional safety criteria related to hyperlipidemia, hypogammaglobulinemia, anaphylaxis, and oral contraceptive use.
    08 Jul 2022
    The overall rationale for the amendment was to include details on serious adverse events (SAE) classification procedures regarding major cardiovascular events (MACE) adjudication.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Jan 28 02:29:38 CET 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA