Clinical Trial Results:
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)
Summary
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EudraCT number |
2021-000665-32 |
Trial protocol |
DE ES IT PL PT NL FR |
Global end of trial date |
30 Nov 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Nov 2024
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First version publication date |
10 Nov 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
80202135SJS2001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04968912 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen-Cilag International NV
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Sponsor organisation address |
Turnhoutseweg 30, Beerse, Belgium, B-2340
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Public contact |
Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Nov 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Nov 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this trial was to evaluate the efficacy of nipocalimab versus placebo in subjects with primary Sjogren's syndrome (pSS).
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Sep 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 30
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Country: Number of subjects enrolled |
Spain: 2
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Country: Number of subjects enrolled |
France: 3
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Country: Number of subjects enrolled |
Italy: 1
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Country: Number of subjects enrolled |
Japan: 7
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Country: Number of subjects enrolled |
Poland: 90
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Country: Number of subjects enrolled |
Portugal: 1
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Country: Number of subjects enrolled |
Taiwan: 4
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Country: Number of subjects enrolled |
United States: 25
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Worldwide total number of subjects |
163
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EEA total number of subjects |
127
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
147
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From 65 to 84 years |
16
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 163 subjects were enrolled, randomised (1:1:1 ratio) in this study and treated with either nipocalimab or placebo. Out of 163 subjects, 136 subjects completed the study. | ||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1: Placebo IV | ||||||||||||||||||||||||||||||||
Arm description |
Subjects received placebo intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 22 along with standard of care treatments (SOC). | ||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received placebo q2w from Week 0 through Week 22 along with SOC.
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Arm title
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Group 2: Nipocalimab 5 mg/kg IV | ||||||||||||||||||||||||||||||||
Arm description |
Subjects received nipocalimab 5 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 22 along with SOC. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Nipocalimab
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Investigational medicinal product code |
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Other name |
JNJ-80202135
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received nipocalimab 5 mg/kg q2w from Week 0 through Week 22 along with SOC.
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Arm title
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Group 3: Nipocalimab 15 mg/kg IV | ||||||||||||||||||||||||||||||||
Arm description |
Subjects received nipocalimab 15 mg/kg IV infusion q2w from Week 0 through Week 22 along with SOC. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Nipocalimab
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Investigational medicinal product code |
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Other name |
JNJ-80202135
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received nipocalimab 15 mg/kg q2w from Week 0 through Week 22 along with SOC.
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Baseline characteristics reporting groups
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Reporting group title |
Group 1: Placebo IV
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Reporting group description |
Subjects received placebo intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 22 along with standard of care treatments (SOC). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: Nipocalimab 5 mg/kg IV
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Reporting group description |
Subjects received nipocalimab 5 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 22 along with SOC. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3: Nipocalimab 15 mg/kg IV
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Reporting group description |
Subjects received nipocalimab 15 mg/kg IV infusion q2w from Week 0 through Week 22 along with SOC. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1: Placebo IV
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Reporting group description |
Subjects received placebo intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 22 along with standard of care treatments (SOC). | ||
Reporting group title |
Group 2: Nipocalimab 5 mg/kg IV
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Reporting group description |
Subjects received nipocalimab 5 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 22 along with SOC. | ||
Reporting group title |
Group 3: Nipocalimab 15 mg/kg IV
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Reporting group description |
Subjects received nipocalimab 15 mg/kg IV infusion q2w from Week 0 through Week 22 along with SOC. |
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End point title |
Change From Baseline in Clinical European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24 | ||||||||||||||||
End point description |
In clinESSDAI, physician scores the systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). Each domain was assigned a weight between 1 and 7, and domain score was multiplied by domain weight. A higher score indicates worsening of the disease. Sum of the weighted domain scores is the overall score, which can range from 0 to 135. The full analysis set (FAS) included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis 2 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 53 and 54.
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Comparison groups |
Group 3: Nipocalimab 15 mg/kg IV v Group 1: Placebo IV
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Number of subjects included in analysis |
84
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.002 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Point estimate |
-2.65
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
-4.03 | ||||||||||||||||
upper limit |
-1.28 | ||||||||||||||||
Statistical analysis title |
Statistical Analysis 1 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
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Comparison groups |
Group 2: Nipocalimab 5 mg/kg IV v Group 1: Placebo IV
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Number of subjects included in analysis |
86
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.681 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Point estimate |
-0.34
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
-1.71 | ||||||||||||||||
upper limit |
1.03 |
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End point title |
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 24 | ||||||||||||||||
End point description |
Change from baseline in ESSPRI score at Week 24 was reported. The ESSPRI was a patient-reported assessment of the severity of dryness, fatigue, and pain associated with primary sogrens syndrome. Subjects were asked to rate the severity of dryness, fatigue and pain over the past 2 weeks on a numeric rating scale (NRS), ranging from 0 “no symptom" to 10 “maximal imaginable" symptoms (dryness, fatigue, pain). Each domain was scored on scale of 0 to 10 (0 =no symptom at all and 10 = worst symptom imaginable). A total score was calculated as the mean of the 3 individual domain scores, where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10, where higher ESSPRI scores indicated more severe symptoms. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Improvement of Greater Than or Equal to (>=)4 Points From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score (Minimal Clinically Important Improvement) at Week 24 | ||||||||||||||||
End point description |
ESSDAI was a validated tool used in clinical studies to measure systemic disease activity in subjects with primary Sjogren's syndrome. In ESSDAI, physician scores the systemic disease activity level on 12 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). Each domain was assigned a weight between 1 and 6, and domain score was multiplied by domain weight. Sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates worsening of disease. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis 4 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
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Comparison groups |
Group 3: Nipocalimab 15 mg/kg IV v Group 1: Placebo IV
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Number of subjects included in analysis |
110
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.138 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
17.7
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
2.8 | ||||||||||||||||
upper limit |
32.7 | ||||||||||||||||
Statistical analysis title |
Statistical Analysis 3 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
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Comparison groups |
Group 1: Placebo IV v Group 2: Nipocalimab 5 mg/kg IV
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Number of subjects included in analysis |
109
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.648 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
5.4
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
-9.2 | ||||||||||||||||
upper limit |
20 |
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End point title |
Number of Subjects With Improvement of Greater Than or Equal to (>=)4 Points From Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24 | ||||||||||||
End point description |
ESSDAI was a validated tool used in clinical studies to measure systemic disease activity in subjects with primary Sjogren's syndrome. In ESSDAI, physician scores the systemic disease activity level on 12 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). Each domain was assigned a weight between 1 and 6, and domain score was multiplied by domain weight. Sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates worsening of disease. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Improvement of >=4 Points From Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24 | ||||||||||||||||
End point description |
Percentage of subjects with improvement of >= 4 points from baseline in clinESSDAI score (minimal clinically important improvement) at Week 24 were reported. In clinESSDAI, physician scores the systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). A higher score indicates worsening of the disease. Each domain is assigned a weight between 1 and 7, and the domain score is multiplied by the domain weight. Sum of the weighted domain scores is the overall score, which can range from 0 to 135. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis 6 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
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Comparison groups |
Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
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Number of subjects included in analysis |
110
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.138 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
17.9
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Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
2.6 | ||||||||||||||||
upper limit |
33.2 | ||||||||||||||||
Statistical analysis title |
Statistical Analysis 5 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
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Comparison groups |
Group 1: Placebo IV v Group 2: Nipocalimab 5 mg/kg IV
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||||||||||||||||
Number of subjects included in analysis |
109
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.766 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
3.8
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Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
-11.3 | ||||||||||||||||
upper limit |
18.9 |
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End point title |
Number of Subjects With Improvement of >=4 Points From Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24 | ||||||||||||
End point description |
Number of subjects with improvement of >= 4 points from baseline in clinESSDAI score (minimal clinically important improvement) at Week 24 were reported. In clinESSDAI, physician scores the systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). A higher score indicates worsening of the disease. Each domain is assigned a weight between 1 and 7, and the domain score is multiplied by the domain weight. Sum of the weighted domain scores is the overall score, which can range from 0 to 135. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With ESSPRI Response Defined as a Decrease of one Point or a Decrease of >= 15 Percent (%) in the ESSPRI Score From Baseline (Minimal Clinically Important Improvement) at Week 24 | ||||||||||||||||
End point description |
Percentage of subjects with ESSPRI response defined as a decrease of one point or a decrease of >= 15% from baseline (minimal clinically important improvement) at Week 24 was reported. The ESSPRI was a patient-reported assessment of the severity of dryness, fatigue, and pain associated with primary sjogren's syndrome. Subjects were asked to rate the severity of dryness, fatigue and pain over the past 2 weeks on a NRS, ranging from 0 “no symptom” to 10 “maximal imaginable" symptoms (dryness, fatigue, pain). Each domain was scored on scale of 0 to 10 (0 =no symptom at all and 10 = worst symptom imaginable). A total score was calculated as the mean of the 3 individual domain scores, where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10, where higher ESSPRI scores indicated more severe symptoms. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis 8 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
|
||||||||||||||||
Comparison groups |
Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
|
||||||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.788 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
5.6
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-10.1 | ||||||||||||||||
upper limit |
21.2 | ||||||||||||||||
Statistical analysis title |
Statistical Analysis 7 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
|
||||||||||||||||
Comparison groups |
Group 1: Placebo IV v Group 2: Nipocalimab 5 mg/kg IV
|
||||||||||||||||
Number of subjects included in analysis |
109
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.28 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
-10.4
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-26 | ||||||||||||||||
upper limit |
5.2 |
|
|||||||||||||
End point title |
Number of Subjects With ESSPRI Response Defined as a Decrease of one Point or a Decrease of >= 15 % in the ESSPRI Score From Baseline (Minimal Clinically Important Improvement) at Week 24 | ||||||||||||
End point description |
Number of subjects with ESSPRI response defined as a decrease of one point or a decrease of >= 15% from baseline (minimal clinically important improvement) at Week 24 was reported. The ESSPRI was a patient-reported assessment of the severity of dryness, fatigue, and pain associated with primary sjogren's syndrome. Subjects were asked to rate the severity of dryness, fatigue and pain over the past 2 weeks on a NRS, ranging from 0 “no symptom” to 10 “maximal imaginable" symptoms (dryness, fatigue, pain). Each domain was scored on scale of 0 to 10 (0 =no symptom at all and 10 = worst symptom imaginable). A total score was calculated as the mean of the 3 individual domain scores, where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10, where higher ESSPRI scores indicated more severe symptoms. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Percentage of Subjects With Disease Response According to the Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24 | ||||||||||||||||
End point description |
Percentage of subjects with disease response according to the STAR composite score at Week 24 was reported. A STAR response is defined as a composite score of >=5 points in the 5 STAR domains, with weighting in parentheses: i) decrease of >=3 in clinESSDAI score (3), ii) decrease of >=1 point or >=15% from baseline in ESSPRI score (3), iii) abnormal Schirmer's test at baseline and an increase of >=5 millimetre (mm), or normal Schirmer's test at baseline and no change to abnormal, or abnormal ocular staining score at baseline and a decrease of >=2 points, or normal ocular staining score at baseline and no change to abnormal (1), iv) increase of >=25% in unstimulated whole saliva or any increase if score is 0 at baseline (1), v) decrease of >=25% in rheumatoid factor or decrease of >=10% in immunoglobulin G (IgG) (1). The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
At Week 24
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Statistical Analysis 10 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
|
||||||||||||||||
Comparison groups |
Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
|
||||||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.017 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
23.7
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
8.4 | ||||||||||||||||
upper limit |
38.9 | ||||||||||||||||
Statistical analysis title |
Statistical Analysis 9 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
|
||||||||||||||||
Comparison groups |
Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
|
||||||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.218 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
11.7
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-3.9 | ||||||||||||||||
upper limit |
27.2 |
|
|||||||||||||
End point title |
Number of Subjects With Disease Response According to the STAR Composite Score at Week 24 | ||||||||||||
End point description |
Number of subjects with disease response according to the STAR composite score at Week 24 was reported. A STAR response is defined as a composite score of >=5 points in the 5 STAR domains, with weighting in parentheses: i) decrease of >=3 in clinESSDAI score (3), ii) decrease of >=1 point or >=15% from baseline in ESSPRI score (3), iii) abnormal Schirmer's test at baseline and an increase of >=5 millimetre (mm), or normal Schirmer's test at baseline and no change to abnormal, or abnormal ocular staining score at baseline and a decrease of >=2 points, or normal ocular staining score at baseline and no change to abnormal (1), iv) increase of >=25% in unstimulated whole saliva or any increase if score is 0 at baseline (1), v) decrease of >=25% in rheumatoid factor or decrease of >=10% in immunoglobulin G (IgG) (1). The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Subjects With an Improvement in DAL by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24 | ||||||||||||
End point description |
Number of subjectS with improvement in DAL by >= 1 level in at least one clinESSDAI or ESSDAI domain at Week 24 was reported. In clinESSDAI, physician scores systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). A higher score indicates worsening of the disease. Each domain is assigned a weight between 1 and 7, and the domain score is multiplied by domain weight. Sum of the weighted domain scores is overall score, which can range from 0 to 135. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Percentage of Subjects With an Improvement in Disease Activity Level (DAL) by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24 | ||||||||||||||||
End point description |
Percentage of subjects with improvement in DAL by >= 1 level in at least one clinESSDAI or ESSDAI domain at Week 24 was reported. In clinESSDAI, physician scores systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). A higher score indicates worsening of the disease. Each domain is assigned a weight between 1 and 7, and the domain score is multiplied by domain weight. Sum of the weighted domain scores is overall score, which can range from 0 to 135. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
At Week 24
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Statistical Analysis 12 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
|
||||||||||||||||
Comparison groups |
Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
|
||||||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.046 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
19.8
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
4.5 | ||||||||||||||||
upper limit |
35 | ||||||||||||||||
Statistical analysis title |
Statistical Analysis 11 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
|
||||||||||||||||
Comparison groups |
Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
|
||||||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.047 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
18.9
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
3.6 | ||||||||||||||||
upper limit |
34.2 |
|
|||||||||||||||||
End point title |
Percentage of Subjects With Improvement From Baseline in >= 3 of 5 Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) Categories at Week 24 | ||||||||||||||||
End point description |
Percentage of subjects with Improvement from baseline in >= 3 of 5 CRESS categories at week 24 was reported. CRESS was a composite tool that incorporates measures of disease activity (clinESSDAI), symptoms (ESSPRI), glandular function and systemic inflammation to assess disease activity. A CRESS response was defined as a response in >=3 of the following 5 categories: i) clinESSDAI score <5 (low disease activity), ii) decrease of >=1 point or >=15% from baseline in ESSPRI score, iii) abnormal Schirmer's test at baseline (<=5 mm) and an increase of >=5 mm, or normal Schirmer's test at baseline and no change to abnormal, iv) increase of >=25% in unstimulated whole saliva or any increase if score is 0 at baseline, v) decrease of >=25% in rheumatoid factor or decrease of >=10% in IgG. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
at Week 24
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Statistical Analysis 14 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
|
||||||||||||||||
Comparison groups |
Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
|
||||||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.001 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
30.3
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
16.3 | ||||||||||||||||
upper limit |
44.3 | ||||||||||||||||
Statistical analysis title |
Statistical Analysis 13 | ||||||||||||||||
Statistical analysis description |
Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
|
||||||||||||||||
Comparison groups |
Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
|
||||||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.006 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Difference in proportion | ||||||||||||||||
Point estimate |
25.5
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
11.5 | ||||||||||||||||
upper limit |
39.5 |
|
|||||||||||||
End point title |
Number of Subjects With Improvement From Baseline in >= 3 of 5 CRESS Categories at Week 24 | ||||||||||||
End point description |
Number of subjects with Improvement from baseline in >= 3 of 5 CRESS categories at week 24 was reported. CRESS was a composite tool that incorporates measures of disease activity (clinESSDAI), symptoms (ESSPRI), glandular function and systemic inflammation to assess disease activity. A CRESS response was defined as a response in >=3 of the following 5 categories: i) clinESSDAI score <5 (low disease activity), ii) decrease of >=1 point or >=15% from baseline in ESSPRI score, iii) abnormal Schirmer's test at baseline (<=5 mm) and an increase of >=5 mm, or normal Schirmer's test at baseline and no change to abnormal, iv) increase of >=25% in unstimulated whole saliva or any increase if score is 0 at baseline, v) decrease of >=25% in rheumatoid factor or decrease of >=10% in IgG. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | ||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Post first administration of study intervention (Week 0) up to 30 weeks
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Subjects With Adverse Events of Special Interests (AESIs) | ||||||||||||
End point description |
Number of subjects with AESIs were reported. AEs was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. Treatment-emergent adverse events associated with the following situations are considered as AESIs: severe infections, severe hypoalbuminemia. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Post first administration of study intervention (Week 0) up to 30 weeks
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Subjects With Treatment-emergent Serious Adverse Events (SAEs) | ||||||||||||
End point description |
Treatment-emergent SAEs were defined as SAEs with onset or worsening on or after date of first dose of study treatment. An AE is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE 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 or any situation deemed medically important by the investigator. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
post first administration of study intervention (Week 0) up to 30 weeks
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Subjects With TEAEs Leading to Treatment Discontinuation | ||||||||||||
End point description |
Number of subjects with TEAEs leading to treatment discontinuation were reported. AEs was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Post first administration of study intervention (Week 0) up to 30 weeks
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of Subjects With Clinically Significant Abnormalities in Vital Signs | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of subject with clinically significant abnormalities in vital signs were reported. Vital sign parameters including temperature (less than [<]36 and greater than [>] 38), pulse rate (<=50 beats per minute [bpm] and with >=15 bpm decrease from baseline and >=120 bpm and with >=15 bpm increase from baseline), and blood pressure (systolic blood pressure [SBP]: <=90 millimeters of mercury [mmHg] and with >=20 mmHg decrease from baseline and diastolic blood pressure [DBP]: <=50 mmHg and with >=15 mmHg decrease from baseline and >=100 mmHg and with >=15 mmHg increase from baseline). The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Only those categories in which at least 1 subject had data were reported.
|
||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
post first administration of study intervention (Week 0) up to 30 weeks
|
||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of Subjects With Clinically Significant Abnormalities in Laboratory Parameters | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Laboratory parameters included hematology (platelet count [platelets: decrease >20% and value <100 (fraction 1)], red blood cell count, hemoglobin, hematocrit, white blood cell count with differential [lymphocytes: decrease >20% and value <0.08 ], [leukocytes: decrease >10% and value <2.5], [neutrophils: increase >30% and value >0.90], [eosinophils: increase >20% and value >0.10 ]), serum chemistry (phosphate [decrease >10% and value <0.6 ), lipid panel (high-density lipoprotein [HDL] and low-density lipoprotein [LDL], creatine kinase: increase >20% and value >960, cholesterol: value >=6.2), urinalysis, and blood coagulation. Safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, W: denotes week, N: number of subjects evaluable, and n: number of subjects evaluable for each arm at specific time points. Only those categories in which at least 1 subject had data were reported.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Serum Nipocalimab Concentration Over Time [1] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Serum concentrations of nipocalimab over time in subjects receiving active study intervention will be reported. The pharmacokinetics (PK) analysis set was defined as all randomised subjects who had received at least 1 complete dose of nipocalimab and have at least 1 valid post-dose blood sample drawn for PK analysis. This endpoint was planned to be analysed for specified arms only. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Weeks 0, 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up pre dose and post dose
|
||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The data was planned to be analysed for specified arms only. |
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline in C-reactive Protein (CRP) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change from baseline in biomarkers CRP were reported. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and Week 30/final safety follow-up visit
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change from baseline in biomarkers ESR were reported. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Total Immunoglobulin [Ig]G, IgG1, IgG2, IgG3, IgG4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change from baseline in total immunoglobulin [Ig]G, IgG1, IgG2, IgG3, IgG4 were reported. The pharmacodynamic (PD) analysis set was defined as subjects who had received at least 1 dose (partial or complete) of nipocalimab and have at least 1 valid post-dose blood sample drawn for PD analysis. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Autoantibodies : Anti-Sjogren's Syndrome Related Antigen A (anti-Ro/SSA), Anti-Sjogren's Syndrome Related Antigen B (anti-La/SSB), and Anti-Ro52/TRIM21 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change from baseline in autoantibodies included anti-Ro/SSA, anti-La/SSB, and anti-Ro52/tripartite motif-containing protein 21 (Anti-Ro52/TRIM21) were reported. The PD analysis set was defined as subjects who had received at least 1 dose (partial or complete) of nipocalimab and have at least 1 valid post-dose blood sample drawn for PD analysis. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Autoantibodies: Rheumatoid Factor (RF) | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change from baseline in autoantibodies included RF were reported. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From baseline (Week 0) up to 30 Weeks
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Adverse event reporting additional description |
The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
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Reporting groups
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Reporting group title |
Group 1: Placebo IV
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Reporting group description |
Subjects received placebo intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 22 along with standard of care treatments (SOC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3: Nipocalimab 15 mg/kg IV
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Reporting group description |
Subjects received nipocalimab 15 mg/kg IV infusion q2w from Week 0 through Week 22 along with SOC. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: Nipocalimab 5 mg/kg IV
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Reporting group description |
Subjects received nipocalimab 5 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 22 along with SOC. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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26 May 2021 |
The purpose of this amendment was to include additional safety criteria related to hypogammaglobulinemia, hyperlipidemia, and anaphylaxis; to update the use of oral contraceptives; and to clarify the use of NSAIDs prior to study visits involving joint counts or pain assessments. |
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04 Feb 2022 |
The purpose of this amendment was to amend eligibility criteria to include a broader population of Sjögren’s disease patients. |
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20 Jul 2022 |
The purpose of this amendment was to revise the inclusion criterion and secondary endpoint (Sjogren's Syndrome Responder Index response) that depends on erythrocyte sedimentation rate (ESR) as key laboratory supplies required for the ESR test that meet European Union Conformité Européene CE marking requirements for laboratory tests were no longer commercially available. In addition, a new secondary endpoint (Sjögren’s Tool for Assessing Response) was added. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |