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

NCT04572841 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-10-09

Study results available
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Summary

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.

Conditions

  • Sjögren's Syndrome
  • Sjogren's Syndrome

Interventions

DRUG

SAR441344

Pharmaceutical form: solution for injection Route of administration: intravenous or subcutaneous

DRUG

Placebo

Pharmaceutical form: solution for injection Route of administration: intravenous or subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2023-11-08
Completion
2024-02-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Chile
  • France
  • Germany
  • Hungary
  • Mexico
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572841 on ClinicalTrials.gov