Trial Outcomes & Findings for Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients (NCT NCT04605978)
NCT ID: NCT04605978
Last Updated: 2024-04-23
Results Overview
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
From baseline to week 13
Results posted on
2024-04-23
Participant Flow
Participant milestones
| Measure |
S95011 Concentrate for Solution for Infusion
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
|
S95011 Placebo Concentrate for Solution for Infusion
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
17
|
|
Overall Study
COMPLETED
|
28
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
S95011 Concentrate for Solution for Infusion
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
|
S95011 Placebo Concentrate for Solution for Infusion
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal nonmedical reason
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
Baseline characteristics by cohort
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Duration since diagnosis of pSS (years)
|
7.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
6.5 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
7.2 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Patient taking a specific treatment for pSS (for randomization stratification)
Nothing
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Patient taking a specific treatment for pSS (for randomization stratification)
Oral corticosteroid
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Patient taking a specific treatment for pSS (for randomization stratification)
Antimalarial
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Patient taking a specific treatment for pSS (for randomization stratification)
Oral corticosteroid and antimalarial
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 13Population: Change in ESSDAI Total Score is computed only on observed values before occurrence of Intercurrent Events.
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
Outcome measures
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
Change in ESSDAI Total Score
Change from Baseline to Week 13
|
-3.77 score on a scale
Standard Deviation 4.55
|
-5.54 score on a scale
Standard Deviation 4.89
|
|
Change in ESSDAI Total Score
Baseline
|
11.52 score on a scale
Standard Deviation 3.75
|
13.12 score on a scale
Standard Deviation 7.20
|
|
Change in ESSDAI Total Score
Week 13
|
7.96 score on a scale
Standard Deviation 4.91
|
8.85 score on a scale
Standard Deviation 8.59
|
SECONDARY outcome
Timeframe: At baseline, week 4 and week 13Population: ESSDAI Score by Domain and Total Score is computed without consideration of Intercurrent Events, therefore data gathered after an intercurrent event is not set as "missing". The participant data that is missing from Week 4 and Week 13 was not available.
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. There are 12 organ-specific domains and for each domain, features of disease activity are scored according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The total score ranges from 0 to 123. A higher score always represents a more severe disease activity. The domain \[weight\] and score range are as follows: Constitutional \[3\] 0-2; Lymphadenopathy and lymphoma \[4\] 0-3; Glandular \[2\] 0-2; Articular \[2\] 0-3; Cutaneous \[3\] 0-3; Pulmonary \[5\] 0-3; Renal \[5\] 0-3; Muscular \[6\] 0-3; PNS \[5\] 0-3; CNS \[5\] 0-3; Hematological \[2\] 0-3; Biological \[1\] 0-2.
Outcome measures
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
ESSDAI Score by Domain and Total Score
Total Score - Baseline
|
11.5 score on a scale
Standard Deviation 3.7
|
13.1 score on a scale
Standard Deviation 7.2
|
|
ESSDAI Score by Domain and Total Score
Total Score - Week 4
|
9.5 score on a scale
Standard Deviation 3.7
|
10.8 score on a scale
Standard Deviation 7.2
|
|
ESSDAI Score by Domain and Total Score
Total Score - Week 13
|
7.8 score on a scale
Standard Deviation 4.8
|
9.7 score on a scale
Standard Deviation 8.3
|
|
ESSDAI Score by Domain and Total Score
Constitutional - Baseline
|
0.6 score on a scale
Standard Deviation 0.7
|
0.4 score on a scale
Standard Deviation 0.6
|
|
ESSDAI Score by Domain and Total Score
Constitutional - Week 4
|
0.5 score on a scale
Standard Deviation 0.7
|
0.2 score on a scale
Standard Deviation 0.4
|
|
ESSDAI Score by Domain and Total Score
Constitutional - Week 13
|
0.4 score on a scale
Standard Deviation 0.7
|
0.2 score on a scale
Standard Deviation 0.6
|
|
ESSDAI Score by Domain and Total Score
Lymphadenopathy and lymphoma - Baseline
|
0.5 score on a scale
Standard Deviation 0.8
|
0.6 score on a scale
Standard Deviation 0.6
|
|
ESSDAI Score by Domain and Total Score
Lymphadenopathy and lymphoma - Week 4
|
0.3 score on a scale
Standard Deviation 0.7
|
0.3 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Lymphadenopathy and lymphoma - Week 13
|
0.4 score on a scale
Standard Deviation 0.7
|
0.4 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Glandular - Baseline
|
0.7 score on a scale
Standard Deviation 0.7
|
0.7 score on a scale
Standard Deviation 0.7
|
|
ESSDAI Score by Domain and Total Score
Glandular - Week 4
|
0.6 score on a scale
Standard Deviation 0.6
|
0.6 score on a scale
Standard Deviation 0.6
|
|
ESSDAI Score by Domain and Total Score
Glandular - Week 13
|
0.4 score on a scale
Standard Deviation 0.6
|
0.5 score on a scale
Standard Deviation 0.7
|
|
ESSDAI Score by Domain and Total Score
Articular - Baseline
|
1.5 score on a scale
Standard Deviation 1.1
|
1.6 score on a scale
Standard Deviation 1.2
|
|
ESSDAI Score by Domain and Total Score
Articular - Week 4
|
1.1 score on a scale
Standard Deviation 1.1
|
1.3 score on a scale
Standard Deviation 1.3
|
|
ESSDAI Score by Domain and Total Score
Articular - Week 13
|
0.6 score on a scale
Standard Deviation 0.7
|
0.7 score on a scale
Standard Deviation 1.0
|
|
ESSDAI Score by Domain and Total Score
Cutaneous - Baseline
|
0.3 score on a scale
Standard Deviation 0.6
|
0.1 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Cutaneous - Week 4
|
0.2 score on a scale
Standard Deviation 0.6
|
0.1 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Cutaneous - Week 13
|
0.3 score on a scale
Standard Deviation 0.6
|
0.2 score on a scale
Standard Deviation 0.8
|
|
ESSDAI Score by Domain and Total Score
Pulmonary - Baseline
|
0.0 score on a scale
Standard Deviation 0.2
|
0.3 score on a scale
Standard Deviation 0.6
|
|
ESSDAI Score by Domain and Total Score
Pulmonary - Week 4
|
0.0 score on a scale
Standard Deviation 0.2
|
0.3 score on a scale
Standard Deviation 0.6
|
|
ESSDAI Score by Domain and Total Score
Pulmonary - Week 13
|
0.0 score on a scale
Standard Deviation 0.0
|
0.2 score on a scale
Standard Deviation 0.6
|
|
ESSDAI Score by Domain and Total Score
Renal - Baseline
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
ESSDAI Score by Domain and Total Score
Renal - Week 4
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
ESSDAI Score by Domain and Total Score
Renal - Week 13
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
ESSDAI Score by Domain and Total Score
Muscular - Baseline
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
ESSDAI Score by Domain and Total Score
Muscular - Week 4
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
ESSDAI Score by Domain and Total Score
Muscular - Week 13
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
ESSDAI Score by Domain and Total Score
Peripheral Nervous System (PNS) - Baseline
|
0.1 score on a scale
Standard Deviation 0.2
|
0.2 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Peripheral Nervous System (PNS) - Week 4
|
0.0 score on a scale
Standard Deviation 0.2
|
0.2 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Peripheral Nervous System (PNS) - Week 13
|
0.0 score on a scale
Standard Deviation 0.2
|
0.2 score on a scale
Standard Deviation 0.6
|
|
ESSDAI Score by Domain and Total Score
Central Nervous System (CNS) - Baseline
|
0.0 score on a scale
Standard Deviation 0.0
|
0.1 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Central Nervous System (CNS) - Week 4
|
0.0 score on a scale
Standard Deviation 0.0
|
0.1 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Central Nervous System (CNS) - Week 13
|
0.0 score on a scale
Standard Deviation 0.0
|
0.1 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Hematological - Baseline
|
0.6 score on a scale
Standard Deviation 0.7
|
0.4 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Hematological - Week 4
|
0.7 score on a scale
Standard Deviation 0.7
|
0.5 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Hematological - Week 13
|
0.8 score on a scale
Standard Deviation 0.8
|
0.4 score on a scale
Standard Deviation 0.5
|
|
ESSDAI Score by Domain and Total Score
Biological - Baseline
|
0.9 score on a scale
Standard Deviation 0.8
|
0.8 score on a scale
Standard Deviation 0.8
|
|
ESSDAI Score by Domain and Total Score
Biological - Week 4
|
0.9 score on a scale
Standard Deviation 0.8
|
0.9 score on a scale
Standard Deviation 0.9
|
|
ESSDAI Score by Domain and Total Score
Biological - Week 13
|
0.8 score on a scale
Standard Deviation 0.8
|
1.1 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: At baseline, week 4 and week 13Population: The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)
Efficacy criterion EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is an index designed to measure patients' symptoms in primary Sjögren's Syndrome. The three domains included in this scale are dryness, fatigue, and pain, each of which are scored on a scale of 0-10. The total score is calculated as the average of the three domain scores and therefore the maximum total score is 10. The higher score represents more severe symptoms.
Outcome measures
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
ESSPRI Score by Symptom and Total Score
Total score - Baseline
|
7.14 score on a scale
Standard Deviation 1.59
|
6.87 score on a scale
Standard Deviation 1.65
|
|
ESSPRI Score by Symptom and Total Score
Total score - Week 4
|
6.65 score on a scale
Standard Deviation 1.83
|
5.19 score on a scale
Standard Deviation 1.97
|
|
ESSPRI Score by Symptom and Total Score
Total score - Week 13
|
5.54 score on a scale
Standard Deviation 2.06
|
5.40 score on a scale
Standard Deviation 2.71
|
|
ESSPRI Score by Symptom and Total Score
Dryness score - Baseline
|
7.46 score on a scale
Standard Deviation 1.69
|
7.06 score on a scale
Standard Deviation 2.38
|
|
ESSPRI Score by Symptom and Total Score
Dryness score - Week 4
|
6.96 score on a scale
Standard Deviation 2.20
|
5.64 score on a scale
Standard Deviation 2.47
|
|
ESSPRI Score by Symptom and Total Score
Dryness score - Week 13
|
6.54 score on a scale
Standard Deviation 1.91
|
6.62 score on a scale
Standard Deviation 2.43
|
|
ESSPRI Score by Symptom and Total Score
Fatigue score - Baseline
|
7.43 score on a scale
Standard Deviation 1.43
|
7.18 score on a scale
Standard Deviation 2.24
|
|
ESSPRI Score by Symptom and Total Score
Fatigue score - Week 4
|
6.88 score on a scale
Standard Deviation 2.15
|
5.29 score on a scale
Standard Deviation 2.58
|
|
ESSPRI Score by Symptom and Total Score
Fatigue score - Week 13
|
5.71 score on a scale
Standard Deviation 2.74
|
5.15 score on a scale
Standard Deviation 3.21
|
|
ESSPRI Score by Symptom and Total Score
Pain score - Baseline
|
6.54 score on a scale
Standard Deviation 2.63
|
6.35 score on a scale
Standard Deviation 2.21
|
|
ESSPRI Score by Symptom and Total Score
Pain score - Week 4
|
6.13 score on a scale
Standard Deviation 2.85
|
4.64 score on a scale
Standard Deviation 2.71
|
|
ESSPRI Score by Symptom and Total Score
Pain score - Week 13
|
4.38 score on a scale
Standard Deviation 3.21
|
4.46 score on a scale
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: At baseline and week 13Population: The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)
Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL. Scores for each subscale range from 0 - 100, with a lower number representing a worse quality of life.
Outcome measures
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
Quality of Life (SF-36)
Physical score - Baseline
|
38.729 score on a scale
Standard Deviation 9.742
|
40.295 score on a scale
Standard Deviation 8.236
|
|
Quality of Life (SF-36)
Physical score - Week 13
|
45.139 score on a scale
Standard Deviation 9.409
|
47.011 score on a scale
Standard Deviation 9.819
|
|
Quality of Life (SF-36)
Mental score - Baseline
|
40.911 score on a scale
Standard Deviation 10.909
|
44.182 score on a scale
Standard Deviation 13.208
|
|
Quality of Life (SF-36)
Mental score - Week 13
|
41.970 score on a scale
Standard Deviation 14.562
|
45.050 score on a scale
Standard Deviation 14.275
|
SECONDARY outcome
Timeframe: At baseline and week 13Population: The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline (for all domains) but observed data at other timepoints and inversely).
Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate five dimensions of fatigue. Scores range from 4 to 20 for each sub-score, with a lower score representing less fatigue.
Outcome measures
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
Fatigue (MFI)
Reduced motivation score - Week 13
|
10.3 score on a scale
Standard Deviation 4.5
|
8.8 score on a scale
Standard Deviation 4.5
|
|
Fatigue (MFI)
General fatigue score - Baseline
|
15.1 score on a scale
Standard Deviation 3.0
|
15.2 score on a scale
Standard Deviation 3.6
|
|
Fatigue (MFI)
General fatigue score - Week 13
|
13.2 score on a scale
Standard Deviation 3.5
|
13.5 score on a scale
Standard Deviation 5.3
|
|
Fatigue (MFI)
Physical fatigue score - Baseline
|
14.3 score on a scale
Standard Deviation 2.7
|
13.9 score on a scale
Standard Deviation 3.9
|
|
Fatigue (MFI)
Physical fatigue score - Week 13
|
12.6 score on a scale
Standard Deviation 3.9
|
11.4 score on a scale
Standard Deviation 5.2
|
|
Fatigue (MFI)
Reduced activity score - Baseline
|
12.9 score on a scale
Standard Deviation 3.0
|
12.3 score on a scale
Standard Deviation 3.8
|
|
Fatigue (MFI)
Reduced activity score - Week 13
|
11.4 score on a scale
Standard Deviation 4.7
|
9.7 score on a scale
Standard Deviation 4.3
|
|
Fatigue (MFI)
Reduced motivation score - Baseline
|
11.3 score on a scale
Standard Deviation 4.1
|
9.1 score on a scale
Standard Deviation 3.1
|
|
Fatigue (MFI)
Mental fatigue score - Baseline
|
11.6 score on a scale
Standard Deviation 3.9
|
10.5 score on a scale
Standard Deviation 3.7
|
|
Fatigue (MFI)
Mental fatigue score - Week 13
|
11.4 score on a scale
Standard Deviation 4.9
|
9.5 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: At baseline and week 13Population: The number analyzed for Week 13 is less due to missing patient data.
Efficacy criterion Physician's global assessment (PhGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.
Outcome measures
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
Physician's Global Assessment (PhGA) of the Disease Activity
Baseline
|
6.0 score on a scale
Standard Deviation 1.5
|
6.3 score on a scale
Standard Deviation 1.3
|
|
Physician's Global Assessment (PhGA) of the Disease Activity
Week 13
|
3.6 score on a scale
Standard Deviation 1.3
|
4.2 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: At baseline and week 13Population: The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)
Efficacy criterion Patient's global assessment (PGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.
Outcome measures
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
Patient's Global Assessment (PGA) of the Disease Activity
Baseline
|
7.1 score on a scale
Standard Deviation 2.1
|
7.1 score on a scale
Standard Deviation 2.1
|
|
Patient's Global Assessment (PGA) of the Disease Activity
Week 13
|
6.2 score on a scale
Standard Deviation 2.3
|
5.4 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Through study completion, up to Week 28Safety criterion
Outcome measures
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 Participants
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 Participants
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Patients having reported at least one serious AE
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Patients having reported at least one treatment emergent adverse event (TEAE)
|
24 Participants
|
11 Participants
|
Adverse Events
S95011 Concentrate for Solution for Infusion
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
S95011 Placebo Concentrate for Solution for Infusion
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 participants at risk
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 participants at risk
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
0.00%
0/17 • Through Week 28 (about 6 months)
|
|
Eye disorders
Amaurosis fugax
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
0.00%
0/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Herpes zoster
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
0.00%
0/17 • Through Week 28 (about 6 months)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
Other adverse events
| Measure |
S95011 Concentrate for Solution for Infusion
n=31 participants at risk
S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
S95011 Placebo Concentrate for Solution for Infusion
n=17 participants at risk
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
16.1%
5/31 • Through Week 28 (about 6 months)
|
11.8%
2/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Parotitis
|
6.5%
2/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Oral Herpes
|
6.5%
2/31 • Through Week 28 (about 6 months)
|
0.00%
0/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Cystitis
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.9%
4/31 • Through Week 28 (about 6 months)
|
0.00%
0/17 • Through Week 28 (about 6 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
General disorders
Discomfort
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.5%
2/31 • Through Week 28 (about 6 months)
|
0.00%
0/17 • Through Week 28 (about 6 months)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Through Week 28 (about 6 months)
|
0.00%
0/17 • Through Week 28 (about 6 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.2%
1/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/31 • Through Week 28 (about 6 months)
|
5.9%
1/17 • Through Week 28 (about 6 months)
|
Additional Information
Clinical Studies Department
Institut de Recherches Internationales Servier (I.R.I.S.)
Phone: +33 1 55 72 60 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place