Trial Outcomes & Findings for Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus (NCT NCT04781816)
NCT ID: NCT04781816
Last Updated: 2025-08-27
Results Overview
The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. Baseline was defined as the Day 1 assessment value.
COMPLETED
PHASE2
78 participants
Baseline (Day 1) and Week 12
2025-08-27
Participant Flow
The study was conducted at 50 centers in 15 countries. A total of 132 participants were screened from 01 April 2021 to 01 March 2023, of which 54 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
A total of 78 participants were randomized in a ratio of 1:1 to either SAR443122 or placebo arm. The randomization was stratified by subtype of cutaneous lupus erythematosus (CLE) (discoid lupus erythematosus \[DLE\] or subacute cutaneous lupus erythematosus \[SCLE\]), baseline use of hydroxychloroquine/chloroquine (HCQ/CQ) and by region.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to SAR443122 orally twice a day (BID) for 12 weeks.
|
SAR443122
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to SAR443122 orally twice a day (BID) for 12 weeks.
|
SAR443122
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Not Related to Coronavirus Disease 2019
|
1
|
1
|
Baseline Characteristics
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 9.8 • n=93 Participants
|
45.6 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
45.9 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.
The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. Baseline was defined as the Day 1 assessment value.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=35 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12
|
-37.05 percent change
Standard Error 5.31
|
-42.76 percent change
Standard Error 5.42
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement.
The PhysGA- disease activity is a 5 point-Lickert scale instrument designed to assess physician-reported disease activity. The investigators were asked the following question "How active would you say your patient's cutaneous lupus erythematosus is currently?" The total score on scale ranges from 0 (not active at all) to 4 (extremely active). Higher score indicates a more severe skin disease.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12
|
32.5 percentage of participants
|
44.74 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.
The Peak Pruritus NRS (itch-NRS) is a single item patient reported outcomes (PRO) tool that participants used to report the intensity of their pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 (no itch) to 10 (worst itch imaginable) NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". The total score on scale ranges from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates a more severe skin disease. Baseline was defined as the average of daily non-missing scores obtained during the week prior to Day 1.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=36 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12
|
-0.62 score on a scale
Standard Error 0.37
|
-2.16 score on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.
The Peak Pain NRS (Pain-NRS) is a single item PRO tool that participants used to report the intensity of their CLE-related pain (skin, oral, genital) during a daily recall period. Participants were asked to rate their worst pain on a 0 (no pain) to 10 (worst pain imaginable) NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no pain' and 10 being the 'worst pain imaginable', how would you rate your pain at the worst moment due to your lupus during the previous 24 hours?". The total score on scale ranges from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates a more severe skin disease. Baseline was defined as the average of daily non-missing scores obtained during the week prior to Day 1.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=36 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12
|
-0.93 score on a scale
Standard Error 0.32
|
-1.72 score on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement.
The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. The CLASI-A50/75 responder was defined as a participant who achieved a decrease by at least 50%/75% of CLASI-A sub-score from baseline.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12
CLASI-A50
|
45 percentage of responders
|
44.74 percentage of responders
|
|
Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12
CLASI-A75
|
10 percentage of responders
|
23.68 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 12, and 16Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Weeks 4, 8, 12, and 16 for each specified category are reported.
The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering two dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. CLASI-D disease damage covers the domains: dyspigmentation, scarring/atrophy/panniculitis, and clinically judged scarring of the scalp (including scarring alopecia). Scale ranges 0 (absence of disease damage) to 56 (severe disease damage) using the parameters of dyspigmentation and scarring. For CLASI-A and CLASI-D, higher score indicates a more severe skin disease. Change from baseline in CLASI components' score are reported. Baseline was defined as the Day 1 assessment value.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in CLASI Components' Score Over Time
Erythema: Weeks 4
|
-2.33 score on a scale
Standard Deviation 3.24
|
-2.14 score on a scale
Standard Deviation 3.02
|
|
Change From Baseline in CLASI Components' Score Over Time
Erythema: Weeks 8
|
-3.37 score on a scale
Standard Deviation 4.48
|
-3.42 score on a scale
Standard Deviation 3.80
|
|
Change From Baseline in CLASI Components' Score Over Time
Erythema: Weeks 12
|
-4.97 score on a scale
Standard Deviation 4.89
|
-4.17 score on a scale
Standard Deviation 4.15
|
|
Change From Baseline in CLASI Components' Score Over Time
Erythema: Weeks 16
|
-5.09 score on a scale
Standard Deviation 4.00
|
-4.18 score on a scale
Standard Deviation 4.38
|
|
Change From Baseline in CLASI Components' Score Over Time
Scale/Hypertrophy: Week 4
|
-0.83 score on a scale
Standard Deviation 1.32
|
-1.86 score on a scale
Standard Deviation 2.47
|
|
Change From Baseline in CLASI Components' Score Over Time
Scale/Hypertrophy: Week 8
|
-1.34 score on a scale
Standard Deviation 2.34
|
-2.72 score on a scale
Standard Deviation 3.19
|
|
Change From Baseline in CLASI Components' Score Over Time
Scale/Hypertrophy: Week 12
|
-2.03 score on a scale
Standard Deviation 2.99
|
-3.17 score on a scale
Standard Deviation 3.34
|
|
Change From Baseline in CLASI Components' Score Over Time
Scale/Hypertrophy: Week 16
|
-2.12 score on a scale
Standard Deviation 2.58
|
-3.30 score on a scale
Standard Deviation 3.54
|
|
Change From Baseline in CLASI Components' Score Over Time
Scarring/Atrophy/Panniculitis: Week 4
|
-0.13 score on a scale
Standard Deviation 0.88
|
-0.16 score on a scale
Standard Deviation 0.83
|
|
Change From Baseline in CLASI Components' Score Over Time
Scarring/Atrophy/Panniculitis: Week 8
|
-0.08 score on a scale
Standard Deviation 1.08
|
-0.25 score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in CLASI Components' Score Over Time
Scarring/Atrophy/Panniculitis: Week 12
|
-0.06 score on a scale
Standard Deviation 1.37
|
-0.06 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline in CLASI Components' Score Over Time
Scarring/Atrophy/Panniculitis: Week 16
|
-0.24 score on a scale
Standard Deviation 1.48
|
-0.18 score on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.
The IGA-CLE is a clinician reported outcome (ClinRO) that allows for clinicians to assess the overall disease activity of CLE using a 5-point scale: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). The severity of CLE is determined by descriptions of a combination of 3 plaque characteristics: erythema, scale, elevation. Erythema is the primary characteristic that influenced the rating, with other characteristics considered secondarily. Telangiectatic change is not considered in the rating. The assessment did not require the presence of all 4 characteristics, the severity was averaged over the observed characteristics. The total score on scale ranges from 0 to 4. Higher score indicates a more severe skin disease.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=34 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment of Cutaneous Lupus Erythematosus (IGA-CLE) Score of 0 or 1 (Clear Or Almost Clear) at Week 12
|
15.79 percentage of participants
|
26.47 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.
The OHIP-14 is a PRO questionnaire that is composed of 14 items that assess 7 different dimensions, considering the perception of the individual in relation to the impact of oral conditions in the physical, psychological and social well-being in the last month. Each of the 14 items has a set of possible answers distributed in a Likert scale (0 = never, 1 = hardly ever. 2 = occasionally 3 = fairly often, 4 = very often), which represents the frequency that the individual perceives the impact of oral health on 7 dimensions: functional limitation (2 items), physical pain (2 items), psychological discomfort (2 items), physical disability (2 items), psychological disability (2 items), social disability (2 items) and handicap (2 items). The OHIP-14 scores range from 0 to 56 and are calculated by summing the ordinal values for 14 items. Domain scores range from 0 to 8. Higher OHIP-14 scores indicate worse oral-health-related quality of life. Baseline was defined as Day 1 assessment value.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=13 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in the Oral Health Impact Profile 14-Item Version (OHIP-14) for Participants With Oral Lesions at Baseline
|
-2.90 score on a scale
Standard Deviation 7.68
|
-0.15 score on a scale
Standard Deviation 4.79
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement.
Skindex 29+3 is a PRO measure designed to assess the effects of skin disease on participants' health-related quality of life in adults. It contains the following domains: emotions (10 items), symptoms (7 items), functioning (12 items), lupus-specific issues (3 questions), and 1 item about treatment that is not part of the total score. Recall period is during the past week. Each item is rated on a 5-point Likert scale (never, rarely, sometimes, often, all the time). These responses are then transformed to a linear scale ranging from 0 to 100 in 25-point increments, with 100 representing maximal disability. The total score is the average of participants' responses to items in a given domain, ranging from 0 to 100, where higher scores indicate a greater impact on the health-related quality of life. Baseline was defined as the Day 1 assessment value.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in SKINDEX-29+3 Total Score at Week 12
|
-9.09 score on a scale
Standard Error 2.31
|
-11.09 score on a scale
Standard Error 2.35
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to end of study (Week 16)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 study treatment, whether or not considered related to the study treatment. TEAEs were defined as the adverse events that occurred from the time of the first IMP administration up to the end of study visit. Serious adverse events (SAE): Any AE 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, was a medically important event. 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=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)
Any AESI
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)
Any TEAE
|
18 Participants
|
22 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)
Any TESAE
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to end of study (Week 16)Population: 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; Platelets \<100 x 10\^9 per liter (/L) or ≥ 700 x 10\^9/L; Erythrocytes ≥ 6 x 10\^12/L; Leukocytes \< 3 x 10\^9/L (Non-Black \[NB\]); \< 2 x 10\^9/L (Black\[B\]); or ≥ 16 x 10\^9/L; Neutrophils \< 1.5 x 10\^9/L (NB); \< 1 x 10\^9/L (B); Lymphocytes \> 4 x 10\^9/L; 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 range (ULN) (if ULN ≥ 0.5 x 10\^9/L).
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Hb: ≤ 115 g/L (M); ≤ 95 g/L (F)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Hb: ≥ 185 g/L (M); ≥ 165 g/L (F)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Decrease from baseline ≥ 20 g/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Platelets < 100 x 10^9/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Platelets ≥ 700 x 10^9/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Erythrocytes ≥ 6 x 10^12/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Leukocytes < 3 x 10^9/L (NB); < 2 x 10^9/L (B)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Leukocytes ≥ 16 x 10^9/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Neutrophils < 1.5 x 10^9/L (NB); < 1 x 10^9/L (B)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Lymphocytes > 4 x 10^9/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Monocytes > 0.7 x 10^9/L
|
1 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Basophils > 0.1 x 10^9/L
|
6 Participants
|
5 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Eosinophils > 0.5 x 10^9/L or > ULN
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to end of study (Week 16)Population: 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: Glucose ≤ 3.9 millimoles per liter (mmol/L) and \< lower limit of normal range (LLN) or ≥ 11.1 mmol/L (unfasted); ≥ 7 mmol/L (fasted); Creatine Kinase \> 3 ULN; Sodium ≤ 129 mmol/L or ≥ 160 mmol/L; Potassium \< 3 mmol/L or ≥ 5.5 mmol/L; Creatinine ≥ 150 micromoles per liter (μmol/L) (Adults) or ≥ 30% change from baseline or ≥ 100% change from baseline; Creatinine Clearance ≥ 60 - \< 90 milliliters per minute (mL/min) (mild decrease in glomerular filtration rate \[GFR\]) or ≥ 30 - \< 60 mL/min (moderate decrease in GFR) or ≥ 15 - \< 30 mL/min (severe decrease in GFR) or \< 15 mL/min (end stage renal disease); Alanine Aminotransferase \> 3 ULN or \> 5 ULN; Aspartate Aminotransferase \> 3 ULN or \> 5 ULN; Alkaline Phosphatase \> 1.5 ULN; Total Bilirubin \> 1.5 ULN.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With PCSA in Clinical Chemistry
Glucose ≤ 3.9 mmol/L and < LLN
|
4 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Glucose ≥11.1 mmol/L(unfasted); ≥7mmol/L(fasted)
|
1 Participants
|
3 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Creatine Kinase > 3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Sodium ≤ 129 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Sodium ≥ 160 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Potassium < 3 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Potassium ≥ 5.5 mmol/L
|
2 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Creatinine ≥ 150 μmol/L (Adults)
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Creatinine ≥ 30% change from baseline
|
2 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Creatinine ≥ 100% change from baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Creatinine Clearance ≥ 60 - < 90 mL/min
|
10 Participants
|
8 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Creatinine Clearance ≥ 30 - < 60 mL/min
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Creatinine Clearance ≥ 15 - < 30 mL/min
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Creatinine Clearance < 15 mL/min
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Alanine Aminotransferase > 3 ULN
|
1 Participants
|
2 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Alanine Aminotransferase > 5 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Aspartate Aminotransferase > 3 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Aspartate Aminotransferase > 5 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Alkaline Phosphatase > 1.5 ULN
|
5 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Clinical Chemistry
Total Bilirubin > 1.5 ULN
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to end of study (Week 16)Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered). Only participants with data collected for each specified category at Week 16 are reported.
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: pH ≤ 4.6 or ≥ 8.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With PCSA in Urinalysis
pH ≤ 4.6
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Urinalysis
pH ≥ 8
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to end of study (Week 16)Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered). Only participants with data collected for each specified category at Week 16 are reported.
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: Heart Rate (HR) \< 50 beats/min (bpm) or \< 50 bpm and decrease from baseline ≥ 20 bpm or \< 40 bpm or \> 90 bpm; PR Interval \> 200 milliseconds (msec) or \> 200 msec and increase from baseline ≥ 25% or \> 220 msec; QRS Interval \> 110 msec or 110 msec and increase from baseline ≥ 25% or \> 120 msec; QT Interval \> 500 msec; corrected QT (QTc) Interval \> 450 msec or \> 480 msec or increase from baseline \[30-60\] msec or increase from baseline \> 60 msec.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
HR < 50 bpm
|
2 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
HR < 50 bpm and decrease from baseline ≥ 20 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
HR < 40 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
HR > 90 bpm
|
2 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
PR Interval > 200 msec
|
2 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
PR Interval >200 msec;increase from baseline ≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
PR Interval > 220 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
QRS Interval > 110 msec
|
0 Participants
|
2 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
QRS Interval >110 msec;increase from baseline≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
QRS Interval > 120 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
QT Interval > 500 msec
|
1 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
QTc Interval > 450 msec
|
1 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
QTc Interval > 480 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
QTc Interval: Increase from baseline [30-60] msec
|
4 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Electrocardiogram (ECG)
QTc Interval: Increase from baseline > 60 msec
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to end of study (Week 16)Population: Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered). Only participants with data collected for each specified category at Week 16 are reported.
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: Diastolic Blood Pressure (DBP) ≤ 45 millimeters of mercury (mmHg) and decrease from baseline ≥ 10 mmHg or ≥ 110 mmHg and increase from baseline ≥ 10 mmHg; Pulse Rate (PR) ≤ 50 bpm and decrease from baseline ≥ 20 bpm or ≥ 120 bpm and increase from baseline ≥ 20 bpm; Systolic Blood Pressure (SBP) ≤ 95 mmHg and decrease from baseline ≥ 20 mmHg or ≥ 160 mmHg and increase from baseline ≥ 20 mmHg; Weight ≥ 5% decrease from baseline or ≥ 5% increase from baseline.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 Participants
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With PCSA in Vital Signs
PR ≥ 120 bpm and increase from baseline ≥ 20 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Vital Signs
DBP ≤45 mmHg and decrease from baseline ≥10 mmHg
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Vital Signs
DBP ≥110 mmHg and increase from baseline ≥10 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Vital Signs
PR ≤ 50 bpm and decrease from baseline ≥ 20 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Vital Signs
SBP ≤95 mmHg; decrease from baseline ≥20 mmHg
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCSA in Vital Signs
SBP ≥160 mmHg; increase from baseline ≥20 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With PCSA in Vital Signs
Weight ≥ 5% decrease from baseline
|
3 Participants
|
5 Participants
|
|
Number of Participants With PCSA in Vital Signs
Weight ≥ 5% increase from baseline
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57Population: PK population included all randomized and treated participants for whom the PK data are considered interpretable. Participants with data collected at Day 1, 57, and 85 are reported.
Blood samples were collected at the specified timepoints. Cmax was assessed by a Bayesian analysis using the population PK model.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SAR443122
Day 1
|
3334 ng/mL
Standard Deviation 1365
|
—
|
|
Maximum Plasma Concentration (Cmax) of SAR443122
Day 57
|
4875 ng/mL
Standard Deviation 1541
|
—
|
|
Maximum Plasma Concentration (Cmax) of SAR443122
Day 85
|
4896 ng/mL
Standard Deviation 2013
|
—
|
SECONDARY outcome
Timeframe: 2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57Population: PK population included all randomized and treated participants for whom the PK data are considered interpretable. Participants with data collected at Day 1, 57, and 85 are reported.
Blood samples were collected at the specified timepoints. tmax was assessed by a Bayesian analysis using the population PK model.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of SAR443122
Day 1
|
2.80 hours
Interval to 4.9
NA signifies that some tmax values were not calculable for participants with a low compliance, because all concentrations were below the lower limit of quantification.
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of SAR443122
Day 57
|
2.60 hours
Interval to 4.35
NA signifies that some tmax values were not calculable for participants with a low compliance, because all concentrations were below the lower limit of quantification.
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of SAR443122
Day 85
|
2.55 hours
Interval to 4.3
NA signifies that some tmax values were not calculable for participants with a low compliance, because all concentrations were below the lower limit of quantification.
|
—
|
SECONDARY outcome
Timeframe: 2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57Population: PK population included all randomized and treated participants for whom the PK data are considered interpretable. Participants with data collected at Day 1, 57, and 85 are reported.
Blood samples were collected at the specified timepoints. AUC0-12 was assessed by a Bayesian analysis using the population PK model.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of SAR443122
Day 1
|
30151 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 14926
|
—
|
|
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of SAR443122
Day 57
|
40194 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 15831
|
—
|
|
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of SAR443122
Day 85
|
44489 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 19232
|
—
|
SECONDARY outcome
Timeframe: 1 hour before morning dose and 2-5 hours post first morning dose on Day 85Population: PK population included all randomized and treated participants for whom the PK data are considered interpretable. Participants with data collected at Day 85 are reported.
Blood samples were collected at the specified timepoints. t1/2z was assessed by a Bayesian analysis using the population PK model.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Terminal Elimination Half-Life (t1/2z) of SAR443122
|
7.62 hours
Standard Deviation 2.28
|
—
|
Adverse Events
Placebo
SAR443122
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 participants at risk
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
Participants received placebo matched to SAR443122 orally BID for 12 weeks.
|
SAR443122
n=38 participants at risk
Participants received SAR443122 300 mg orally BID for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Eye disorders
Maculopathy
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
General disorders
Asthenia
|
5.0%
2/40 • Number of events 2 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Covid-19
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Folliculitis
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis Viral
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Herpes Zoster
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Nail Infection
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
7.9%
3/38 • Number of events 3 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Periodontitis
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Tinea Pedis
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
2/40 • Number of events 3 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Investigations
Urine Protein/Creatinine Ratio Increased
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Obesity
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
3/40 • Number of events 3 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone Cyst
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • Number of events 2 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Nervous system disorders
Tension Headache
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Breast Mass
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Cutaneous Lupus Erythematosus
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
2.5%
1/40 • Number of events 1 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
0.00%
0/38 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/40 • From first dose of study treatment (Day 1) up to end of study (Week 16)
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • From first dose of study treatment (Day 1) up to end of study (Week 16)
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