Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS) (NCT NCT04572841)
NCT ID: NCT04572841
Last Updated: 2025-10-09
Results Overview
ESSDAI is validated and established outcome measurement for therapeutic efficacy in Sjögren's syndrome, evaluating disease activity mainly on extra-glandular manifestations. This score consists of 12 organ-specific domains (constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral and central nervous system, hematological, biological), which are scored based on organ-specific items in 3 to 4 different severity grades (no, low, moderate, high; with 0=no and 3=high). These scores are summed up over all 12 domains in weighted way (severity grades are multiplied with weights ranging 1-6 depending on domain) to summarize into total score(0-123). Higher scores indicates worse outcome. Negative change from baseline indicates improvement. Baseline=Day 1 assessment value. Least squares (LS) mean is calculated using mixed models for repeated measures (MMRM). Observed values after occurrence of intercurrent events are excluded.
COMPLETED
PHASE2
84 participants
Baseline (Day 1) to Week 12
2025-10-09
Participant Flow
The study was conducted at 35 centers in 12 countries. A total of 234 participants were screened from 12 November 2020 to 10 August 2023, of which 150 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
A total of 84 participants were randomized in a ratio of 1:1 to either placebo or SAR441344 (frexalimab) arm. Randomization was stratified by Baseline European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI) score greater than or equal to (≥) 5 versus less than (\<) 5.
Participant milestones
| Measure |
Placebo
Participants received a single intravenous (IV) loading dose of placebo matched to SAR441344 on Day 1, followed by a subcutaneous (SC) dose of placebo matched to SAR441344 administered once every 2 weeks (q2w) at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 milligram (mg) on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single intravenous (IV) loading dose of placebo matched to SAR441344 on Day 1, followed by a subcutaneous (SC) dose of placebo matched to SAR441344 administered once every 2 weeks (q2w) at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 milligram (mg) on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
49.2 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
48.5 years
STANDARD_DEVIATION 12.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Missing/Not reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score
|
10.38 score on a scale
STANDARD_DEVIATION 3.64 • n=93 Participants
|
8.43 score on a scale
STANDARD_DEVIATION 3.88 • n=4 Participants
|
9.40 score on a scale
STANDARD_DEVIATION 3.87 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Efficacy population included all randomly assigned participants who actually received at least 1 complete dose of IMP with at least 1 post-IMP administration measurement, with available Baseline assessment of the ESSDAI. Only participants with data collected for this outcome measure are reported.
ESSDAI is validated and established outcome measurement for therapeutic efficacy in Sjögren's syndrome, evaluating disease activity mainly on extra-glandular manifestations. This score consists of 12 organ-specific domains (constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral and central nervous system, hematological, biological), which are scored based on organ-specific items in 3 to 4 different severity grades (no, low, moderate, high; with 0=no and 3=high). These scores are summed up over all 12 domains in weighted way (severity grades are multiplied with weights ranging 1-6 depending on domain) to summarize into total score(0-123). Higher scores indicates worse outcome. Negative change from baseline indicates improvement. Baseline=Day 1 assessment value. Least squares (LS) mean is calculated using mixed models for repeated measures (MMRM). Observed values after occurrence of intercurrent events are excluded.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=38 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Change From Baseline to Week 12 in ESSDAI Score
|
-5.60 score on a scale
Standard Error 0.60
|
-5.29 score on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Efficacy population included all randomly assigned participants who actually received at least 1 complete dose of IMP with at least 1 post-IMP administration measurement, with available Baseline assessment of the ESSDAI. Only participants with data collected for this outcome measure are reported.
The ESSPRI is a validated and established outcome measurement, reported by participants, which rates the key disease manifestations: fatigue, dryness, and pain, based on a numeric scale ranging from 0 to 10, where 0 is defined as no symptoms and 10 as maximum imaginable complaints. The total score is the mean score of the 3 scales and ranges from 0 to 10. Higher scores indicates worse outcome. A negative change from baseline indicates improvement. Baseline is defined as Day 1 assessment value. LS mean is calculated using MMRM. Observed values after occurrence of intercurrent events are excluded.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=38 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Change From Baseline to Week 12 in European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI) Score
|
-2.21 score on a scale
Standard Error 0.34
|
-1.92 score on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Efficacy population included all randomly assigned participants who actually received at least 1 complete dose of IMP with at least 1 post-IMP administration measurement, with available Baseline assessment of the ESSDAI. Only participants with data collected for this outcome measure are reported.
The MFI is a validated, 20 item self-report instrument to evaluate fatigue by investigating the following subscales: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each subscale consists of 4 items that are scored using a scale from 1 ("yes, this is true") to 5 ("no, this is not true") on which the participants indicate how the listed statements applied to their current fatigue situation. Item scores are summed to create individual subscale score ranging from 4 to 20. A higher score indicates a higher degree of fatigue. A negative change from baseline indicates improvement. Baseline is defined as Day 1 assessment value. LS mean is calculated using ANCOVA. Observed values after occurrence of intercurrent events are excluded.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=38 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score
General Fatigue Scale Score
|
0.37 score on a scale
Standard Error 0.30
|
-0.18 score on a scale
Standard Error 0.30
|
|
Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score
Mental Fatigue Scale Score
|
0.26 score on a scale
Standard Error 0.36
|
0.37 score on a scale
Standard Error 0.36
|
|
Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score
Physical Fatigue Scale Score
|
0.27 score on a scale
Standard Error 0.36
|
-0.30 score on a scale
Standard Error 0.36
|
|
Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score
Reduced Activity Scale Score
|
0.22 score on a scale
Standard Error 0.31
|
0.29 score on a scale
Standard Error 0.31
|
|
Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score
Reduced Motivation Scale Score
|
0.30 score on a scale
Standard Error 0.30
|
0.26 score on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: At end of infusion and 4 hours post-infusion on Day 1; pre-dose at Weeks 2, 4, 6, 8, 10, and at Week 12Population: Pharmacokinetic (PK) population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected at specified timepoints for each specified category are reported.
Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Mean Plasma Concentration of SAR441344
Day 1 (end of infusion)
|
466.10 microgram per milliliter (mcg/mL)
Standard Deviation 93.86
|
—
|
|
Mean Plasma Concentration of SAR441344
Day 1 (4 hours post-infusion)
|
427.22 microgram per milliliter (mcg/mL)
Standard Deviation 102.07
|
—
|
|
Mean Plasma Concentration of SAR441344
Week 2 (pre-dose)
|
139.98 microgram per milliliter (mcg/mL)
Standard Deviation 28.30
|
—
|
|
Mean Plasma Concentration of SAR441344
Week 4 (pre-dose)
|
132.91 microgram per milliliter (mcg/mL)
Standard Deviation 36.21
|
—
|
|
Mean Plasma Concentration of SAR441344
Week 6 (pre-dose)
|
135.18 microgram per milliliter (mcg/mL)
Standard Deviation 46.39
|
—
|
|
Mean Plasma Concentration of SAR441344
Week 8 (pre-dose)
|
141.34 microgram per milliliter (mcg/mL)
Standard Deviation 44.85
|
—
|
|
Mean Plasma Concentration of SAR441344
Week 10 (pre-dose)
|
142.25 microgram per milliliter (mcg/mL)
Standard Deviation 48.80
|
—
|
|
Mean Plasma Concentration of SAR441344
Week 12
|
151.59 microgram per milliliter (mcg/mL)
Standard Deviation 56.49
|
—
|
SECONDARY outcome
Timeframe: At end of infusion and 4 hours post-infusion on Day 1; pre-dose at Weeks 2, 4, 6, 8, 10, and at Week 12Population: PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected at specified timepoints for each specified category are reported.
Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Median Plasma Concentration of SAR441344
Day 1 (end of infusion)
|
479.06 mcg/mL
Interval 302.4 to 652.2
|
—
|
|
Median Plasma Concentration of SAR441344
Day 1 (4 hours post-infusion)
|
408.37 mcg/mL
Interval 253.1 to 623.6
|
—
|
|
Median Plasma Concentration of SAR441344
Week 2 (pre-dose)
|
132.21 mcg/mL
Interval 98.3 to 203.1
|
—
|
|
Median Plasma Concentration of SAR441344
Week 4 (pre-dose)
|
133.01 mcg/mL
Interval 45.6 to 236.5
|
—
|
|
Median Plasma Concentration of SAR441344
Week 6 (pre-dose)
|
127.32 mcg/mL
Interval 60.2 to 237.5
|
—
|
|
Median Plasma Concentration of SAR441344
Week 8 (pre-dose)
|
135.10 mcg/mL
Interval 76.9 to 284.9
|
—
|
|
Median Plasma Concentration of SAR441344
Week 10 (pre-dose)
|
134.39 mcg/mL
Interval 58.0 to 268.1
|
—
|
|
Median Plasma Concentration of SAR441344
Week 12
|
148.11 mcg/mL
Interval 64.4 to 306.2
|
—
|
SECONDARY outcome
Timeframe: After the last SC dose on Week 10 up to 336 hours post-dosePopulation: PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected for this outcome measure are reported.
Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. Cmax was assessed by a Bayesian approach using the population PK model.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SAR441344
|
190 mcg/mL
Standard Deviation 54.5
|
—
|
SECONDARY outcome
Timeframe: After the last SC dose on Week 10 up to 336 hours post-dosePopulation: PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected for this outcome measure are reported.
Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. tmax was assessed by a Bayesian approach using the population PK model.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of SAR441344
|
89.1 hours
Interval 76.8 to 139.0
|
—
|
SECONDARY outcome
Timeframe: After the last SC dose on Week 10 up to 336 hours post-dosePopulation: PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected for this outcome measure are reported.
Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. AUC0-tau was assessed by a Bayesian approach using the population PK model.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344
|
57900 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 18000
|
—
|
SECONDARY outcome
Timeframe: Week 10 to Week 12Population: PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population.
Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. t1/2z was assessed by a Bayesian approach using the population PK model.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Terminal Half-life (t1/2z) of SAR441344
|
662 hours
Interval 374.0 to 997.0
|
—
|
SECONDARY outcome
Timeframe: From first dose of IMP (Day 1) up to end of follow-up period (Week 24)Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that occurred, worsened, or became serious during the TEAE period (time from the first IMP administration up to Week 24). Serious adverse events (SAE): Any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect. An AESI: an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESI)
Any AESI
|
5 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESI)
Any TEAE
|
26 Participants
|
29 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESI)
Any TESAE
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of IMP (Day 1) up to end of follow-up period (Week 24)Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs were AEs that occurred, worsened, or became serious during the TEAE period (time from the first IMP administration up to Week 24).
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With Treatment Discontinuation and Withdrawals Due to TEAEs
Treatment discontinuation due to TEAEs
|
4 Participants
|
4 Participants
|
|
Number of Participants With Treatment Discontinuation and Withdrawals Due to TEAEs
Treatment withdrawal due to TEAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (within 24 hours prior IMP dosing), post-dose (up to 15 minutes after dosing) and 2 hours post-dose at Weeks 2, 4, 6, 8 and 10Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered). Only participants with data collected at specified timepoints for each specified category are reported.
For the measurement of local tolerability, participants had a self-evaluation using a VDS before IMP administration, after completion of the IMP administration, and 2 hours post-administration. The participants were asked to report sensations at the injection site and rated the pain severity as following grading: 0= no pain; 1= mild pain; 2= moderate pain, 3= severe pain, 4= very severe. A positive change in VDS score indicated a higher pain severity compared to the pre-dose pain. The numerical change provides the number of grades the pain got worse (positive change) or improved (negative change). Total number of participants with pain intensity increase (change in VDS score of greater than or equal to 1) compared to pre-dose pain intensity are reported.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=40 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 2: Post-dose versus pre-dose
|
7 Participants
|
7 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 6: Post-dose versus pre-dose
|
13 Participants
|
10 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 8: 2 hours post-dose versus pre-dose
|
3 Participants
|
1 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 10: Post-dose versus pre-dose
|
7 Participants
|
10 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 2: 2 hours post-dose versus pre-dose
|
5 Participants
|
8 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 4: Post-dose versus pre-dose
|
12 Participants
|
8 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 4: 2 hours post-dose versus pre-dose
|
5 Participants
|
6 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 6: 2 hours post-dose versus pre-dose
|
3 Participants
|
3 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 8: Post-dose versus pre-dose
|
7 Participants
|
11 Participants
|
|
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)
Week 10: 2 hours post-dose versus pre-dose
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 10Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Local tolerability at injection site was assessed following IMP injection and findings at the site of injection such as injection site erythema, injection site reaction, and injection site pain were recorded.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With AEs Related to Local Tolerability Findings
Injection site erythema
|
1 Participants
|
3 Participants
|
|
Number of Participants With AEs Related to Local Tolerability Findings
Injection site reaction
|
2 Participants
|
0 Participants
|
|
Number of Participants With AEs Related to Local Tolerability Findings
Injection site pain
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).
PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Sitting systolic blood pressure (SSBP) less than or equal to (≤)95 millimeters of mercury (mmHg) and decrease from baseline ≥20 mmHg; ≥160 mmHg and increase from baseline ≥20 mmHg; Sitting diastolic blood pressure (SDBP) ≤45 mmHg and decrease from baseline ≥10 mmHg, ≥110 mmHg and increase from baseline ≥10 mmHg; Sitting heart rate (HR) ≤50 beats per minute (bpm) and decrease from baseline ≥20 bpm, ≥120 bpm and increase from baseline ≥20 bpm; Weight ≥5% decrease from baseline, ≥5% increase from baseline.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
SSBP: ≥160 mmHg; increase from baseline ≥20 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
SDBP: ≤45 mmHg; decrease from baseline ≥10 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
SDBP: ≥110 mmHg; increase from baseline ≥10 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
Weight: ≥5% increase from baseline
|
2 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
SSBP: ≤95 mmHg; decrease from baseline ≥20 mmHg
|
2 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
Sitting HR: ≤50 bpm; decrease from baseline ≥20 bpm
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
Sitting HR: ≥120 bpm; increase from baseline ≥20 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
Weight: ≥5% decrease from baseline
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).
PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: HR \<50 bpm, \<40 bpm, \>90 bpm, \>90 bpm and increase from baseline ≥20 bpm, \>100 bpm; PR interval, aggregate \>200 milliseconds (msec), \>200 msec and increase from baseline ≥25%, \>220 msec, \>220 msec and increase from baseline ≥25%, \>240 msec, \>240 msec and increase from baseline ≥25%; QRS duration, aggregate \>110 msec, \>110 msec and increase from baseline ≥25%, \>120 msec, \>120 msec and increase from baseline ≥25%; QT interval, aggregate \>500 msec; corrected QT (QTc) correction method unspecified \>450 msec, \>480 msec, increase from baseline \[30-60\] msec, increase from baseline \>60 msec.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With PCSA in Electrocardiogram
HR: <40 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
HR: >90 bpm
|
3 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
HR: >90 bpm; increase from baseline ≥20 bpm
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
HR: >100 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
PR interval, aggregate: >200 msec
|
4 Participants
|
2 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
PR interval, aggregate: >240 msec
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QRS duration, aggregate: >110 msec
|
2 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QRS duration, aggregate: >120 msec
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QRS duration, aggregate: >120 msec; increase from baseline ≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QT interval, aggregate: >500 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QTc correction method unspecified: Increase from baseline >60 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
HR: <50 bpm
|
2 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
PR interval, aggregate: >200 msec; increase from baseline ≥25%
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
PR interval, aggregate: >220 msec
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
PR interval, aggregate: >220 msec; increase from baseline ≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
PR interval, aggregate: >240 msec; increase from baseline ≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QRS duration, aggregate: >110 msec; increase from baseline ≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QTc correction method unspecified: >450 msec
|
5 Participants
|
2 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QTc correction method unspecified: >480 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram
QTc correction method unspecified: Increase from baseline[30-60] msec
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).
PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Hemoglobin (Hb) ≤115 grams per liter (g/L) (Male \[M\]) or ≤95 g/L (Female \[F\]), ≥185 g/L (M) or ≥165 g/L (F), decrease from baseline ≥20 g/L; Hematocrit ≤0.37 volume per volume (v/v) (M) or ≤0.32 v/v (F), ≥0.55 v/v (M) or ≥0.5 v/v (F); Erythrocytes (red blood cells \[RBC\]) ≥6 x 10\^12 per liter (/L); Platelets \<100 x 10\^9/L, ≥700 x 10\^9/L; Leukocytes (white blood cells \[WBC\]) \<3 x 10\^9/L (Non-Black\[NB\]) or \<2 x 10\^9/L (Black\[B\]), ≥16 x 10\^9/L; Neutrophils \<1.5 x 10\^9/L (NB) or \<1 x 10\^9/L (B); Lymphocytes \>4 x 10\^9/L, \<0.5 x 10\^9L; Monocytes \>0.7 x 10\^9/L; Basophils \>0.1 x 10\^9/L; Eosinophils \>0.5 x 10\^9/L or \>upper limit of normal(ULN) (if ULN ≥0.5 x 10\^9/L).
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With PCSA in Hematology Parameters
Hb: ≤115 g/L (M); ≤95 g/L (F)
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Hb: Decrease from baseline ≥20 g/L
|
2 Participants
|
2 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Hematocrit: ≤0.37 v/v (M); ≤0.32 v/v (F)
|
5 Participants
|
3 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Hematocrit: ≥0.55 v/v (M); ≥0.5 v/v (F)
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
RBC: ≥6 x 10^12/L
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
WBC: <3 x 10^9/L (NB); <2 x 10^9/L (B)
|
8 Participants
|
5 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
WBC: ≥16 x 10^9/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Lymphocytes: >4 x 10^9/L
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Lymphocytes: <0.5 x 10^9L
|
2 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Monocytes: >0.7 x 10^9/L
|
1 Participants
|
2 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Basophils: >0.1 x 10^9/L
|
0 Participants
|
8 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Eosinophils: >0.5 x 10^9/L or >ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Platelets: <100 x 10^9/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Platelets: ≥700 x 10^9/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Neutrophils: <1.5 x 10^9/L (NB); <1 x 10^9/L (B)
|
7 Participants
|
7 Participants
|
|
Number of Participants With PCSA in Hematology Parameters
Hb: ≥185 g/L (M); ≥165 g/L (F)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).
PCSA values:abnormal values considered medically important by Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by Sponsor.Criteria for PCSA:Sodium≤129 millimoles per liter(mmol/L),≥160 mmol/L;Potassium\<3 mmol/L,≥5.5 mmol/L;Glucose≤3.9 mmol/L and \<lower limit of normal(LLN),≥11.1 mmol/L(unfasted);≥7 mmol/L(fasted); Creatine kinase(CK)\>3 ULN,\>10 ULN;Creatinine≥150 micromoles/L(adults),≥30% change from baseline,≥100% change from baseline;Creatinine clearance(CG)≥60-\<90 milliliters per minute(mL/min)(mild decrease in glomerular filtration rate\[GFR\]),≥30-\<60 mL/min(moderate decrease in GFR),≥15-\<30 mL/min(severe decrease in GFR),\<15 mL/min(end stage renal disease),Urea nitrogen≥17 mmol/L;Alkaline phosphatase(ALP)\>1.5 ULN;Alanine aminotransferase(ALT)\>3 ULN; ALT\>3 ULN and bilirubin\>2 ULN;Aspartate aminotransferase(AST)\>3 ULN;Direct bilirubin\>35% bilirubin and bilirubin\>1.5 ULN;Total bilirubin\>1.5 ULN,\>2 ULN.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Sodium: ≤129 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Sodium: ≥160 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Potassium: <3 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Potassium: ≥5.5 mmol/L
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Glucose: ≤3.9 mmol/L and <LLN
|
3 Participants
|
5 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Glucose: ≥11.1 mmol/L (unfasted); ≥7 mmol/L (fasted)
|
3 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
CK: >3 ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
CK: >10 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Creatinine: ≥150 micromoles/L (Adults)
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Creatinine: ≥30% change from baseline
|
1 Participants
|
2 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Creatinine: ≥100% change from baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
CG: ≥60 - <90 mL/min
|
24 Participants
|
16 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
CG: ≥30 - <60 mL/min
|
3 Participants
|
2 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
CG: ≥15 - <30 mL/min
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
CG: <15 mL/min
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Urea Nitrogen: ≥17 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
ALP: >1.5 ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
ALT: >3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
ALT >3 ULN; Bilirubin >2 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
AST: >3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Direct Bilirubin >35% Bilirubin; Bilirubin >1.5 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Total Bilirubin: >1.5 ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry Parameters
Total Bilirubin: >2 ULN
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).
PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Potential of hydrogen (pH) ≤4.6 or ≥8.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 Participants
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With PCSA in Urinalysis Parameters
pH ≤4.6
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Urinalysis Parameters
pH ≥8
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, and Week 24Population: ADA population included all randomized participants treated with SAR441344 with at least 1 post-baseline ADA result (positive, negative or inconclusive). Only participants with data collected at specified timepoints are reported.
Serum samples were collected at the specified timepoints for the assessment of ADAs to SAR441344. Number of participants with treatment-emergent ADA defined as at least 1 treatment-induced/boosted ADA during the treatment-emergent period, i.e. from the time of the IMP administration up to the end of study visit are reported. Number of participants with positive ADA are reported.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA) to SAR441344
Baseline
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA) to SAR441344
Week 4
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA) to SAR441344
Week 8
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA) to SAR441344
Week 12
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA) to SAR441344
Week 24
|
5 Participants
|
—
|
Adverse Events
Placebo
SAR441344
Serious adverse events
| Measure |
Placebo
n=42 participants at risk
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 participants at risk
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Infections and infestations
Osteomyelitis Acute
|
2.4%
1/42 • Number of events 1 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
0.00%
0/42 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Product Issues
Device Breakage
|
0.00%
0/42 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
2.4%
1/42 • Number of events 1 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
Other adverse events
| Measure |
Placebo
n=42 participants at risk
Participants received a single IV loading dose of placebo matched to SAR441344 on Day 1, followed by an SC dose of placebo matched to SAR441344 administered q2w at Weeks 2, 4, 6, 8 and 10.
|
SAR441344
n=42 participants at risk
Participants received a single IV loading dose of SAR441344 1200 mg on Day 1, followed by an SC dose of SAR441344 600 mg administered q2w at Weeks 2, 4, 6, 8 and 10.
|
|---|---|---|
|
Infections and infestations
Covid-19
|
9.5%
4/42 • Number of events 4 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
9.5%
4/42 • Number of events 4 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42 • Number of events 3 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
2.4%
1/42 • Number of events 1 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
6/42 • Number of events 6 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
2.4%
1/42 • Number of events 1 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
2/42 • Number of events 2 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
9.5%
4/42 • Number of events 4 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/42 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
7.1%
3/42 • Number of events 4 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
3/42 • Number of events 3 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
0.00%
0/42 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
3/42 • Number of events 4 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
0.00%
0/42 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
3/42 • Number of events 3 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
0.00%
0/42 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
General disorders
Injection Site Erythema
|
2.4%
1/42 • Number of events 3 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
7.1%
3/42 • Number of events 7 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
11.9%
5/42 • Number of events 5 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
9.5%
4/42 • Number of events 5 • From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER