Trial Outcomes & Findings for Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis (NCT NCT04879628)
NCT ID: NCT04879628
Last Updated: 2025-09-30
Results Overview
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
Week 8 and Week 12
Results posted on
2025-09-30
Participant Flow
The study was conducted at 38 centers in 10 countries. A total of 176 participants were screened from 07 June 2021 to 08 June 2022, of which 47 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria. Primary results are presented up to primary completion date (PCD) of 21 September 2022.
A total of 129 participants were randomized in a 4:4:1:1 ratio to receive either intravenous (IV) SAR441344 or subcutaneous (SC) SAR441344 or IV placebo or SC placebo in Part A (double-blind \[DB\] period). After completing Part A, all participants entered Part B (open-label extension \[OLE\] period) where participants in the IV and SC placebo arms switched to corresponding IV and SC SAR441344 arms and participants from SAR441344 arms continued their previous IV or SC treatment after Week 12 visit.
Participant milestones
| Measure |
SC Placebo
Participants received placebo matched to SAR441344 IV infusion loading dose on Day 1 followed by placebo matched to SAR441344 SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, all participants from this arm switched to active SC SAR441344 300 milligram (mg) every 2 weeks (q2w) and then switched to high SC SAR441344 dose of 1800 mg every 4 weeks (q4w) in Part B (OLE period).
|
IV Placebo
Participants received placebo matched to SAR441344 loading dose on Day 1 followed by placebo matched to SAR441344 IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, all participants from this arm switched to active IV SAR441344 1200 mg infusion q4w in Part B (OLE period).
|
SC SAR441344 300 mg
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Part A: DB Period (Up to Week 12)
STARTED
|
14
|
12
|
51
|
52
|
|
Part A: DB Period (Up to Week 12)
COMPLETED
|
14
|
12
|
49
|
50
|
|
Part A: DB Period (Up to Week 12)
NOT COMPLETED
|
0
|
0
|
2
|
2
|
|
Part B: OLE Period (Up to Week 296)
STARTED
|
0
|
0
|
63
|
62
|
|
Part B: OLE Period (Up to Week 296)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Part B: OLE Period (Up to Week 296)
NOT COMPLETED
|
0
|
0
|
63
|
62
|
Reasons for withdrawal
| Measure |
SC Placebo
Participants received placebo matched to SAR441344 IV infusion loading dose on Day 1 followed by placebo matched to SAR441344 SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, all participants from this arm switched to active SC SAR441344 300 milligram (mg) every 2 weeks (q2w) and then switched to high SC SAR441344 dose of 1800 mg every 4 weeks (q4w) in Part B (OLE period).
|
IV Placebo
Participants received placebo matched to SAR441344 loading dose on Day 1 followed by placebo matched to SAR441344 IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, all participants from this arm switched to active IV SAR441344 1200 mg infusion q4w in Part B (OLE period).
|
SC SAR441344 300 mg
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Part A: DB Period (Up to Week 12)
Adverse event: Related to Coronavirus Disease 2019
|
0
|
0
|
1
|
0
|
|
Part A: DB Period (Up to Week 12)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Part A: DB Period (Up to Week 12)
Emergency situation due to war in Ukraine
|
0
|
0
|
0
|
2
|
|
Part B: OLE Period (Up to Week 296)
Ongoing at the time of PCD
|
0
|
0
|
63
|
62
|
Baseline Characteristics
Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
SC Placebo
n=14 Participants
Participants received placebo matched to SAR441344 IV infusion loading dose on Day 1 followed by placebo matched to SAR441344 SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, all participants from this arm switched to active SC SAR441344 300 mg q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV Placebo
n=12 Participants
Participants received placebo matched to SAR441344 loading dose on Day 1 followed by placebo matched to SAR441344 IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, all participants from this arm switched to active IV SAR441344 1200 mg infusion q4w in Part B (OLE period).
|
SC SAR441344 300 mg
n=51 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=52 Participants
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
32.3 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
38.2 years
STANDARD_DEVIATION 8.9 • n=206 Participants
|
37.3 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 9.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
85 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
128 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 8 and Week 12Population: The efficacy population included all participants from the randomized population who took all Part A doses of study drug (1 SC dose skipped was allowed) and with an evaluable primary endpoint. As pre-specified in the statistical analysis plan (SAP), data for placebo arm is presented by pooling SC and IV placebo arms.
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.
Outcome measures
| Measure |
Placebo
n=22 Participants
All participants received placebo matched to SAR441344 in Part A (DB period). At Week 12, all participants from this arm switched to active SAR441344 in Part B (OLE period).
|
SC SAR441344 300 mg
n=45 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=47 Participants
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)
|
1.4 number of new GdE T1 lesions per month
Interval 0.62 to 2.98
|
0.3 number of new GdE T1 lesions per month
Interval 0.13 to 0.59
|
0.2 number of new GdE T1 lesions per month
Interval 0.06 to 0.39
|
—
|
SECONDARY outcome
Timeframe: Week 8 and Week 12Population: The efficacy population included all participants from the randomized population who took all Part A doses of study drug (1 SC dose skipped was allowed) and with an evaluable primary endpoint. As pre-specified in the SAP, data for placebo arm is presented by pooling SC and IV placebo arms.
Cranial (brain) MRI was performed to identify number of new or enlarging T2 lesions at Week 12 relative to Week 8.
Outcome measures
| Measure |
Placebo
n=22 Participants
All participants received placebo matched to SAR441344 in Part A (DB period). At Week 12, all participants from this arm switched to active SAR441344 in Part B (OLE period).
|
SC SAR441344 300 mg
n=45 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=47 Participants
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8
|
3.8 number of new or enlarging T2 lesions
Standard Deviation 6.2
|
0.6 number of new or enlarging T2 lesions
Standard Deviation 1.8
|
0.3 number of new or enlarging T2 lesions
Standard Deviation 0.7
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The efficacy population included all participants from the randomized population who took all Part A doses of study drug (1 SC dose skipped was allowed) and with an evaluable primary endpoint. As pre-specified in the SAP, data for placebo arm is presented by pooling SC and IV placebo arms.
Cranial (brain) MRI was performed to identify total number of GdE T1 lesions at Week 12.
Outcome measures
| Measure |
Placebo
n=22 Participants
All participants received placebo matched to SAR441344 in Part A (DB period). At Week 12, all participants from this arm switched to active SAR441344 in Part B (OLE period).
|
SC SAR441344 300 mg
n=45 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=47 Participants
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Mean Total Number of GdE T1 Lesions at Week 12
|
3.7 number of GdE T1 lesions
Standard Deviation 7.4
|
0.5 number of GdE T1 lesions
Standard Deviation 1.5
|
0.2 number of GdE T1 lesions
Standard Deviation 0.5
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)Population: The safety population included all randomized participants who took at least 1 dose (regardless of the amount) of study drug.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was 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 or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
Outcome measures
| Measure |
Placebo
n=14 Participants
All participants received placebo matched to SAR441344 in Part A (DB period). At Week 12, all participants from this arm switched to active SAR441344 in Part B (OLE period).
|
SC SAR441344 300 mg
n=12 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=51 Participants
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=52 Participants
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
5 Participants
|
3 Participants
|
23 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)Population: The ADA population included all participants from the safety population treated with SAR441344 in Part A with at least 1 post-baseline ADA result (positive, negative or inconclusive).
Blood samples were collected at specified timepoints to assess the presence of ADAs against SAR441344. Treatment-emergent ADA was defined as at least 1 treatment-induced/boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA are presented.
Outcome measures
| Measure |
Placebo
n=14 Participants
All participants received placebo matched to SAR441344 in Part A (DB period). At Week 12, all participants from this arm switched to active SAR441344 in Part B (OLE period).
|
SC SAR441344 300 mg
n=12 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=51 Participants
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=51 Participants
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)Population: The PK population included all randomized and treated participants (safety population) with at least 1 post-baseline PK sample with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.
Blood samples were collected at the specified timepoints for the assessment of Cmax. Cmax was assessed by a Bayesian approach using the population pharmacokinetic (PK) model.
Outcome measures
| Measure |
Placebo
n=48 Participants
All participants received placebo matched to SAR441344 in Part A (DB period). At Week 12, all participants from this arm switched to active SAR441344 in Part B (OLE period).
|
SC SAR441344 300 mg
n=51 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SAR441344
After first dose
|
196 microgram per milliliter (mcg/mL)
Standard Deviation 34.4
|
623 microgram per milliliter (mcg/mL)
Standard Deviation 125
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of SAR441344
After last dose
|
101 microgram per milliliter (mcg/mL)
Standard Deviation 20.9
|
580 microgram per milliliter (mcg/mL)
Standard Deviation 116
|
—
|
—
|
SECONDARY outcome
Timeframe: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)Population: The PK population included all randomized and treated participants (safety population) with at least 1 post-baseline PK sample with adequate documentation of dosing and sampling dates and times.
Blood samples were collected at the specified timepoints for the assessment of tmax. tmax was assessed by a Bayesian approach using the population PK model.
Outcome measures
| Measure |
Placebo
n=48 Participants
All participants received placebo matched to SAR441344 in Part A (DB period). At Week 12, all participants from this arm switched to active SAR441344 in Part B (OLE period).
|
SC SAR441344 300 mg
n=51 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of SAR441344
After first dose
|
1.5 hour
Interval 1.0 to 1.5
|
1.5 hour
Interval 1.0 to 2.0
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of SAR441344
After last dose
|
97.2 hour
Interval 79.0 to 123.0
|
1.38 hour
Interval 0.92 to 1.77
|
—
|
—
|
SECONDARY outcome
Timeframe: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)Population: The PK population included all randomized and treated participants (safety population) with at least 1 post-baseline PK sample with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.
Blood samples were collected at the specified timepoints for the assessment of AUC0-tau. AUC0-tau was assessed by a Bayesian approach using the population PK model.
Outcome measures
| Measure |
Placebo
n=48 Participants
All participants received placebo matched to SAR441344 in Part A (DB period). At Week 12, all participants from this arm switched to active SAR441344 in Part B (OLE period).
|
SC SAR441344 300 mg
n=51 Participants
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344
After first dose
|
32800 mcg*hour/mL
Standard Deviation 3560
|
157000 mcg*hour/mL
Standard Deviation 23900
|
—
|
—
|
|
Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344
After last dose
|
31900 mcg*hour/mL
Standard Deviation 7580
|
190000 mcg*hour/mL
Standard Deviation 39400
|
—
|
—
|
Adverse Events
SC Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IV Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SC SAR441344 300 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
IV SAR441344 1200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SC Placebo
n=14 participants at risk
Participants received placebo matched to SAR441344 IV infusion loading dose on Day 1 followed by placebo matched to SAR441344 SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, all participants from this arm switched to active SC SAR441344 300 mg q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV Placebo
n=12 participants at risk
Participants received placebo matched to SAR441344 loading dose on Day 1 followed by placebo matched to SAR441344 IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, all participants from this arm switched to active IV SAR441344 1200 mg infusion q4w in Part B (OLE period).
|
SC SAR441344 300 mg
n=51 participants at risk
Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period).
|
IV SAR441344 1200 mg
n=52 participants at risk
Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period).
|
|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
9.8%
5/51 • Number of events 5 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
3.9%
2/51 • Number of events 2 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
3.8%
2/52 • Number of events 2 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
8.3%
1/12 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
1.9%
1/52 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
2.0%
1/51 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
5.8%
3/52 • Number of events 3 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Vascular disorders
Hyperaemia
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Defaecation Urgency
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
8.3%
1/12 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
8.3%
1/12 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
8.3%
1/12 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary Retention
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
2.0%
1/51 • Number of events 3 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
General disorders
Injection Site Erythema
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
General disorders
Injection Site Extravasation
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
General disorders
Injection Site Pain
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
8.3%
1/12 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
2.0%
1/51 • Number of events 4 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
1.9%
1/52 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
General disorders
Injury Associated With Device
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
8.3%
1/12 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
8.3%
1/12 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
8.3%
1/12 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/12 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/51 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
0.00%
0/52 • AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610 ext 6#
Email: [email protected]
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