Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
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.