Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS) (phaethuSA)

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS)

Primary Objective:

To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with primary Sjögren's syndrome (pSjS), assessed by the change of the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI)

Secondary Objectives:

• To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
• To evaluate the therapeutic efficacy on fatigue of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
• To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 12 weeks in adult patients with pSjS
• To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo in adult patients with pSjS as determined by adverse events (AEs)
• To evaluate the local tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
• To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS determined by electrocardiogram, vital signs, and laboratory evaluations
• To measure the immunogenicity of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS

This is a multicenter, randomized, double blind, placebo controlled, parallel group proof of concept Phase 2 study to evaluate the therapeutic efficacy of SAR441344 in adult patients with primary Sjögren's syndrome (pSjS), as well as safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).

• Study visit frequency: every 2 weeks in the treatment period and every 4 weeks in the follow-up period.
• The total duration of the study will be 24 weeks (28 weeks including maximum screening duration) for each participant, including a 12-week treatment period and a 12-week follow-up period.

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome; Sjögren's Syndrome
• Intervention / Treatment: Drug: SAR441344; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, 1430
      • Investigational Site Number : 0320004
    • CABA, Buenos Aires, Argentina, C1111
      • Investigational Site Number : 0320002
    • Pergamino, Buenos Aires, Argentina, B2700CPM
      • Investigational Site Number : 0320003
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
      • Investigational Site Number : 0320001
• Belgium
  • Ghent, Belgium, 9000
    • Investigational Site Number : 0560002
  • Leuven, Belgium, 3000
    • Investigational Site Number : 0560001
• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Investigational Site Number : 1240001
• Chile
  • Los Lagos Region
    • Osorno, Los Lagos Region, Chile, 5311092
      • Investigational Site Number : 1520002
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
      • Investigational Site Number : 1520001
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile, 2520598
      • Investigational Site Number : 1520004
• France
  • Limoges, France, 87042
    • Investigational Site Number : 2500003
  • Marseille, France, 13003
    • Investigational Site Number : 2500005
  • Montpellier, France, 34295
    • Investigational Site Number : 2500001
  • Paris, France, 75010
    • Investigational Site Number : 2500004
  • Paris, France, 75013
    • Investigational Site Number : 2500006
  • Strasbourg, France, 67098
    • Investigational Site Number : 2500002
• Germany
  • Berlin, Germany, 10117
    • Investigational Site Number : 2760001
• Hungary
  • Budapest, Hungary, 1036
    • Investigational Site Number : 3480003
  • Debrecen, Hungary, 4032
    • Investigational Site Number : 3480001
  • Székesfehérvár, Hungary, 8000
    • Investigational Site Number : 3480004
• Mexico
  • Chihuahua City, Mexico, 31020
    • Investigational Site Number : 4840003
  • Estado de Baja California
    • Mexicali, Estado de Baja California, Mexico, 21200
      • Investigational Site Number : 4840002
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Investigational Site Number : 4840001
• South Korea
  • Seoul, South Korea, 06591
    • Investigational Site Number : 4100001
  • Daegu
    • Daegu, Daegu, South Korea, 561-712
      • Investigational Site Number : 4100004
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, South Korea, 03080
      • Investigational Site Number : 4100002
• Spain
  • Málaga, Spain, 29010
    • Investigational Site Number : 7240002
  • Andalusia
    • Seville, Andalusia, Spain, 41010
      • Investigational Site Number : 7240003
• Taiwan
  • Taichung, Taiwan, 40447
    • Investigational Site Number : 1580002
  • Tainan City, Taiwan, 704
    • Investigational Site Number : 1580003
  • Taipei, Taiwan, 100
    • Investigational Site Number : 1580001
  • Taoyuan, Taiwan, 33305
    • Investigational Site Number : 1580005
• United States
  • Florida
    • DeBary, Florida, United States, 32713
      • Omega Research Consultants Debary Site Number : 8400005
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research Site Number : 8400001
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Ramesh C. Gupta, M.D. Site Number : 8400007
  • Texas
    • Houston, Texas, United States, 77054
      • Prolato Clinical Research Center Site Number : 8400009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
• Diagnosis of pSjS according to the American College of Rheumatology/EULAR 2016 criteria at Screening.
• Disease duration since first diagnosis of pSjS ≤15 years based on medical history.
• Participants with moderate to severe disease activity set with ESSDAI total score ≥5, based on the following domains at Screening: glandular, articular, muscular, hematological, biological, and constitutional, lymphadenopathy.
• Seropositive for anti-Ro/SSA antibodies.
• IgG > lower limit of normal (ULN) at Screening.
• Stimulated salivary flow rate of ≥0.1 mL/min at Screening or Baseline.
• Body weight within 45 to 120 kg (inclusive) and body mass index within the range of 18.0 to 35.0 kg/m2 (inclusive) at Screening.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent.

Exclusion Criteria:

• Any autoimmune disease (except pSjS and Hashimoto thyroiditis) with or without secondary SjS.
• History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.

• Active life threatening or organ threatening complications of pSjS disease at the time of Screening based on treating physician evaluation including but not restricted to:

  • Vasculitis with renal, digestive, cardiac, pulmonary, or CNS involvement characterized as severe,
  • Active central nervous system (CNS) or peripheral nervous system (PNS) involvement requiring high dose steroids,
  • Severe renal involvement defined by objective measures,
  • Lymphoma.
• Cardiac heart failure Stage III or IV according to the New York Heart Association.
• Severe pulmonary impairment documented by an abnormal pulmonary function test.
• Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or IV antibiotics or significant chronic viral (including history of recurrent or active herpes zoster), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during Screening.
• Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution.
• Evidence of active or latent tuberculosis (TB) as documented by medical history (eg, chest X rays) and examination, and TB testing: A positive or 2 indeterminate QuantiFERON® TB Gold tests at Screening (regardless of prior treatment status).
• Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (eg, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, or any known immune deficiency) or previous, active or pending surgical disorder, or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation).
• History or presence of diseases which exclude diagnosis of SjS as per the American College of Rheumatology/EULAR 2016 criteria including, but not limited to, sarcoidosis, amyloidosis, graft-versus-host disease, IgG4 related disease, and history of head and neck radiation treatment.
• History of systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized monoclonal antibody.
• Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
• Any prior history of malignancy or active malignancy, including lymphoproliferative diseases and lymphoma (except successfully treated carcinoma in situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin) within 5 years prior to Baseline.
• Unstable dose of nonsteroidal anti inflammatory drugs (NSAIDs) and/or unstable use of topical and/or pharmacological stimulant treatment for salivary and lacrimal glands 4 weeks before Screening.
• High dose steroids, or a change in steroid dose within 4 weeks prior to Day 1/Randomization or expected changes during the course of the study.
• High dose of hydroxychloroquine or chloroquine, or methotrexate or change in hydroxychloroquine, chloroquine or methotrexate dose within 12 weeks prior to Day 1/Randomization or expected changes during the course of the study.

• Participants treated with the following medications/procedures prior to Screening:

  • Previous treatment with azathioprine and other thiopurines, mycophenolate mofetil, sulfasalazine, or cyclosporine A within 3 months.
  • Previous treatment with cyclophosphamide, leflunomide, or belimumab within 6 months.
  • Previous treatment with rituximab within 12 months.
  • Previous bone marrow transplantation, total lymphoid irradiation or ablative ultra high dose cyclophosphamide or IV Ig.
  • Previous treatment with any other biologic drug within 5 times the half life of the drug.
• Received administration of any live (attenuated) vaccine within 3 months prior to Day 1/Randomization (eg, varicella zoster vaccine, oral polio, rabies).
• Clinically significant abnormal ECG or vital signs at Screening.
• Abnormal laboratory test(s) at Screening.
• Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
• Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti hepatitis B core antibodies (anti HBc Ab), anti hepatitis C virus antibodies (HCV-Ab).
• If female, pregnant and/or breastfeeding.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Pharmaceutical form: solution for injection Route of administration: intravenous or subcutaneous
Experimental: SAR441344; SAR441344 single intravenous (IV) loading dose on Day 1 followed by a single subcutaneous (SC) dose administered once every 2 weeks from Week 2 to Week 10 (5 administrations)	Drug: SAR441344; Pharmaceutical form: solution for injection Route of administration: intravenous or subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 12 in ESSDAI Score	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.	Baseline (Day 1) to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 12 in European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI) Score	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.	Baseline (Day 1) to Week 12
Change From Baseline to Week 12 in Multidimensional Fatigue Inventory (MFI) General Fatigue Subscale and Other Subscales Score	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.	Baseline (Day 1) to Week 12
Mean Plasma Concentration of SAR441344	Blood samples were collected at the specified timepoints for the measurement of plasma concentrations 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
Median Plasma Concentration of SAR441344	Blood samples were collected at the specified timepoints for the measurement of plasma concentrations 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
Maximum Plasma Concentration (Cmax) of SAR441344	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.	After the last SC dose on Week 10 up to 336 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of SAR441344	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.	After the last SC dose on Week 10 up to 336 hours post-dose
Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344	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.	After the last SC dose on Week 10 up to 336 hours post-dose
Terminal Half-life (t1/2z) of SAR441344	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.	Week 10 to Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESI)	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.	From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Number of Participants With Treatment Discontinuation and Withdrawals Due to TEAEs	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs were AEs that occurred, worsened, or became serious during the TEAE period (time from the first IMP administration up to Week 24).	From first dose of IMP (Day 1) up to end of follow-up period (Week 24)
Number of Participants With Increase in Pain Intensity Compared to Pre-dose Pain Intensity at Injection Site by Verbal Descriptor Scale (VDS)	For the measurement of local tolerability, participants had a self-evaluation using a VDS before IMP administration, after completion of the IMP administration, and 2 hours post-administration. The participants were asked to report sensations at the injection site and rated the pain severity as following grading: 0= no pain; 1= mild pain; 2= moderate pain, 3= severe pain, 4= very severe. A positive change in VDS score indicated a higher pain severity compared to the pre-dose pain. The numerical change provides the number of grades the pain got worse (positive change) or improved (negative change). Total number of participants with pain intensity increase (change in VDS score of greater than or equal to 1) compared to pre-dose pain intensity are reported.	Pre-dose (within 24 hours prior IMP dosing), post-dose (up to 15 minutes after dosing) and 2 hours post-dose at Weeks 2, 4, 6, 8 and 10
Number of Participants With AEs Related to Local Tolerability Findings	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Local tolerability at injection site was assessed following IMP injection and findings at the site of injection such as injection site erythema, injection site reaction, and injection site pain were recorded.	Baseline (Day 1) to Week 10
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Sitting systolic blood pressure (SSBP) less than or equal to (≤)95 millimeters of mercury (mmHg) and decrease from baseline ≥20 mmHg; ≥160 mmHg and increase from baseline ≥20 mmHg; Sitting diastolic blood pressure (SDBP) ≤45 mmHg and decrease from baseline ≥10 mmHg, ≥110 mmHg and increase from baseline ≥10 mmHg; Sitting heart rate (HR) ≤50 beats per minute (bpm) and decrease from baseline ≥20 bpm, ≥120 bpm and increase from baseline ≥20 bpm; Weight ≥5% decrease from baseline, ≥5% increase from baseline.	Baseline (Day 1) to Week 24
Number of Participants With PCSA in Electrocardiogram	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: HR <50 bpm, <40 bpm, >90 bpm, >90 bpm and increase from baseline ≥20 bpm, >100 bpm; PR interval, aggregate >200 milliseconds (msec), >200 msec and increase from baseline ≥25%, >220 msec, >220 msec and increase from baseline ≥25%, >240 msec, >240 msec and increase from baseline ≥25%; QRS duration, aggregate >110 msec, >110 msec and increase from baseline ≥25%, >120 msec, >120 msec and increase from baseline ≥25%; QT interval, aggregate >500 msec; corrected QT (QTc) correction method unspecified >450 msec, >480 msec, increase from baseline [30-60] msec, increase from baseline >60 msec.	Baseline (Day 1) to Week 24
Number of Participants With PCSA in Hematology Parameters	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Hemoglobin (Hb) ≤115 grams per liter (g/L) (Male [M]) or ≤95 g/L (Female [F]), ≥185 g/L (M) or ≥165 g/L (F), decrease from baseline ≥20 g/L; Hematocrit ≤0.37 volume per volume (v/v) (M) or ≤0.32 v/v (F), ≥0.55 v/v (M) or ≥0.5 v/v (F); Erythrocytes (red blood cells [RBC]) ≥6 x 10^12 per liter (/L); Platelets <100 x 10^9/L, ≥700 x 10^9/L; Leukocytes (white blood cells [WBC]) <3 x 10^9/L (Non-Black[NB]) or <2 x 10^9/L (Black[B]), ≥16 x 10^9/L; Neutrophils <1.5 x 10^9/L (NB) or <1 x 10^9/L (B); Lymphocytes >4 x 10^9/L, <0.5 x 10^9L; Monocytes >0.7 x 10^9/L; Basophils >0.1 x 10^9/L; Eosinophils >0.5 x 10^9/L or >upper limit of normal(ULN) (if ULN ≥0.5 x 10^9/L).	Baseline (Day 1) to Week 24
Number of Participants With PCSA in Clinical Chemistry Parameters	PCSA values:abnormal values considered medically important by Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by Sponsor.Criteria for PCSA:Sodium≤129 millimoles per liter(mmol/L),≥160 mmol/L;Potassium<3 mmol/L,≥5.5 mmol/L;Glucose≤3.9 mmol/L and <lower limit of normal(LLN),≥11.1 mmol/L(unfasted);≥7 mmol/L(fasted); Creatine kinase(CK)>3 ULN,>10 ULN;Creatinine≥150 micromoles/L(adults),≥30% change from baseline,≥100% change from baseline;Creatinine clearance(CG)≥60-<90 milliliters per minute(mL/min)(mild decrease in glomerular filtration rate[GFR]),≥30-<60 mL/min(moderate decrease in GFR),≥15-<30 mL/min(severe decrease in GFR),<15 mL/min(end stage renal disease),Urea nitrogen≥17 mmol/L;Alkaline phosphatase(ALP)>1.5 ULN;Alanine aminotransferase(ALT)>3 ULN; ALT>3 ULN and bilirubin>2 ULN;Aspartate aminotransferase(AST)>3 ULN;Direct bilirubin>35% bilirubin and bilirubin>1.5 ULN;Total bilirubin>1.5 ULN,>2 ULN.	Baseline (Day 1) to Week 24
Number of Participants With PCSA in Urinalysis Parameters	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Potential of hydrogen (pH) ≤4.6 or ≥8.	Baseline (Day 1) to Week 24
Number of Participants With Anti-drug Antibodies (ADA) to SAR441344	Serum samples were collected at the specified timepoints for the assessment of ADAs to SAR441344. Number of participants with treatment-emergent ADA defined as at least 1 treatment-induced/boosted ADA during the treatment-emergent period, i.e. from the time of the IMP administration up to the end of study visit are reported. Number of participants with positive ADA are reported.	Baseline, Week 4, Week 8, Week 12, and Week 24

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• ACT16618 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome
• Other Study ID Numbers: ACT16618; 2020-000511-77 (EudraCT Number); U1111-1244-2266 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No