Trial · NCT04572841
Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)
NCT04572841, Phase 2, Completed, Sanofi; results first posted 2025-10-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS). Trials, record NCT04572841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04572841
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)
- NCT number
- NCT04572841
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 84 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Sjögren's Syndrome, Sjogren's Syndrome
- Interventions
- SAR441344, Placebo
- First posted
- 2020-10-01
- Last updated
- 2025-10-09
- Other registries' IDs
- eudract:2020-000511-77
- Results first posted
- 2025-10-09
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in ESSDAI Score | Baseline (Day 1) to Week 12 | ESSDAI is validated and established outcome measurement for therapeutic efficacy in Sjögren's syndrome, evaluating disease activity mainly on extra-glandular manifestations. This score consists of 12 organ-specific domains (constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral and central nervous system, hematological, biological), which are scored based on organ-specific items in 3 to 4 different severity grades (no, low, moderate, high; with 0=no and 3=high). These scores are summed up over all 12 domains in weighted way (severity grades are multiplied with weights ranging 1-6 depending on domain) to summarize into total score(0-123). Higher scores indicates worse outcome. Negative change from baseline indicates improvement. Baseline=Day 1 assessment value. Least squares (LS) mean is calculated using mixed models for repeated measures (MMRM). Observed values after occurrence of intercurrent events are excluded. |
| Secondary | Change From Baseline to Week 12 in European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI) Score | Baseline (Day 1) to Week 12 | The ESSPRI is a validated and established outcome measurement, reported by participants, which rates the key disease manifestations: fatigue, dryness, and pain, based on a numeric scale ranging from 0 to 10, where 0 is defined as no symptoms and 10 as maximum imaginable complaints. The total score is the mean score of the 3 scales and ranges from 0 to 10. Higher scores indicates worse outcome. A negative change from baseline indicates improvement. Baseline is defined as Day 1 assessment value. LS mean is calculated using MMRM. Observed values after occurrence of intercurrent events are excluded. |
| Secondary | Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score | Baseline (Day 1) to Week 12 | The MFI is a validated, 20 item self-report instrument to evaluate fatigue by investigating the following subscales: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each subscale consists of 4 items that are scored using a scale from 1 ("yes, this is true") to 5 ("no, this is not true") on which the participants indicate how the listed statements applied to their current fatigue situation. Item scores are summed to create individual subscale score ranging from 4 to 20. A higher score indicates a higher degree of fatigue. A negative change from baseline indicates improvement. Baseline is defined as Day 1 assessment value. LS mean is calculated using ANCOVA. Observed values after occurrence of intercurrent events are excluded. |
| Secondary | Mean Plasma Concentration of SAR441344 | At end of infusion and 4 hours post-infusion on Day 1; pre-dose at Weeks 2, 4, 6, 8, 10, and at Week 12 | Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. |
| Secondary | Median Plasma Concentration of SAR441344 | At end of infusion and 4 hours post-infusion on Day 1; pre-dose at Weeks 2, 4, 6, 8, 10, and at Week 12 | Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. |
| Secondary | Maximum Plasma Concentration (Cmax) of SAR441344 | After the last SC dose on Week 10 up to 336 hours post-dose | Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. Cmax was assessed by a Bayesian approach using the population PK model. |
| Secondary | Time to Maximum Plasma Concentration (Tmax) of SAR441344 | After the last SC dose on Week 10 up to 336 hours post-dose | Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. tmax was assessed by a Bayesian approach using the population PK model. |
| Secondary | Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344 | After the last SC dose on Week 10 up to 336 hours post-dose | Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. AUC0-tau was assessed by a Bayesian approach using the population PK model. |
| Secondary | Terminal Half-life (t1/2z) of SAR441344 | Week 10 to Week 12 | Blood samples were collected at the specified timepoints for the measurement of plasma concentrations of SAR441344. t1/2z was assessed by a Bayesian approach using the population PK model. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESI) | From first dose of IMP (Day 1) up to end of follow-up period (Week 24) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that occurred, worsened, or became serious during the TEAE period (time from the first IMP administration up to Week 24). Serious adverse events (SAE): Any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect. An AESI: an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in ESSDAI Score | Baseline (Day 1) to Week 12 | Efficacy population included all randomly assigned participants who actually received at least 1 complete dose of IMP with at least 1 post-IMP administration measurement, with available Baseline assessment of the ESSDAI. Only participants with data collected for this outcome measure are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI) Score | Baseline (Day 1) to Week 12 | Efficacy population included all randomly assigned participants who actually received at least 1 complete dose of IMP with at least 1 post-IMP administration measurement, with available Baseline assessment of the ESSDAI. Only participants with data collected for this outcome measure are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score | Baseline (Day 1) to Week 12 | Efficacy population included all randomly assigned participants who actually received at least 1 complete dose of IMP with at least 1 post-IMP administration measurement, with available Baseline assessment of the ESSDAI. Only participants with data collected for this outcome measure are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Plasma Concentration of SAR441344 | At end of infusion and 4 hours post-infusion on Day 1; pre-dose at Weeks 2, 4, 6, 8, 10, and at Week 12 | Pharmacokinetic (PK) population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected at specified timepoints for each specified category are reported. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | Median Plasma Concentration of SAR441344 | At end of infusion and 4 hours post-infusion on Day 1; pre-dose at Weeks 2, 4, 6, 8, 10, and at Week 12 | PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected at specified timepoints for each specified category are reported. | mcg/mL | MEDIAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of SAR441344 | After the last SC dose on Week 10 up to 336 hours post-dose | PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected for this outcome measure are reported. | mcg/mL | MEAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) of SAR441344 | After the last SC dose on Week 10 up to 336 hours post-dose | PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected for this outcome measure are reported. | hours | MEDIAN |
| SECONDARY | Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344 | After the last SC dose on Week 10 up to 336 hours post-dose | PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. Only participants with data collected for this outcome measure are reported. | microgram*hour per milliliter (mcg*h/mL) | MEAN |
| SECONDARY | Terminal Half-life (t1/2z) of SAR441344 | Week 10 to Week 12 | PK population included all randomized and treated participants (safety population) with adequate PK results. Participants who received only placebo were not a part of the PK population. | hours | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESI) | From first dose of IMP (Day 1) up to end of follow-up period (Week 24) | Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group213
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in ESSDAI Score | Placebo | -5.60 | Standard Error 0.60 | score on a scale | |
| Change From Baseline to Week 12 in ESSDAI Score | SAR441344 | -5.29 | Standard Error 0.59 | score on a scale | |
| Change From Baseline to Week 12 in European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI) Score | Placebo | -2.21 | Standard Error 0.34 | score on a scale | |
| Change From Baseline to Week 12 in European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI) Score | SAR441344 | -1.92 | Standard Error 0.34 | score on a scale | |
| Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score | Placebo | General Fatigue Scale Score | 0.37 | Standard Error 0.30 | score on a scale |
| Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score | SAR441344 | General Fatigue Scale Score | -0.18 | Standard Error 0.30 | score on a scale |
| Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score | Placebo | Mental Fatigue Scale Score | 0.26 | Standard Error 0.36 | score on a scale |
| Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score | SAR441344 | Mental Fatigue Scale Score | 0.37 | Standard Error 0.36 | score on a scale |
| Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score | Placebo | Physical Fatigue Scale Score | 0.27 | Standard Error 0.36 | score on a scale |
| Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score | SAR441344 | Physical Fatigue Scale Score | -0.30 | Standard Error 0.36 | score on a scale |
1 to 10 of 213Source ClinicalTrials.gov
See all 213 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 42 | |
| Overall Study | STARTED | SAR441344 | 42 | |
| Overall Study | COMPLETED | Placebo | 39 | |
| Overall Study | COMPLETED | SAR441344 | 40 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | SAR441344 | 2 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Covid-19 | Infections and infestations | Placebo | 4 | 42 | 4 |
| other | Covid-19 | Infections and infestations | SAR441344 | 4 | 42 | 4 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 42 | 3 |
| other | Nasopharyngitis | Infections and infestations | SAR441344 | 1 | 42 | 1 |
| other | Urinary Tract Infection | Infections and infestations | Placebo | 6 | 42 | 6 |
| other | Urinary Tract Infection | Infections and infestations | SAR441344 | 1 | 42 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 2 | 42 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | SAR441344 | 4 | 42 | 4 |
| other | Headache | Nervous system disorders | Placebo | 0 | 42 | 0 |
| other | Headache | Nervous system disorders | SAR441344 | 3 | 42 | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 42 |
| Total, all-cause mortality | SAR441344 | 0 | 42 |
| Total, other adverse events | Placebo | 20 | 42 |
| Total, other adverse events | SAR441344 | 15 | 42 |
| Total, serious adverse events | Placebo | 1 | 42 |
| Total, serious adverse events | SAR441344 | 1 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAR441344 vs Placebo: deaths from any cause | Trial comparisons |
| SAR441344 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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