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NCT04572841 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT04572841: Completed Phase 2 study, sponsored by Sanofi.
NCT04572841 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04572841, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG SAR441344
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-11-12 |
| Est. Completion | 2024-02-09 |
| Phase | Phase 2 |
What the finished NCT04572841 record still lists
NCT04572841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04572841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04572841 about?
NCT04572841 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in 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) ...
What is the current status of trial NCT04572841?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2020-11-12. Estimated completion is 2024-02-09.
What interventions are being tested in trial NCT04572841?
The interventions under investigation include: Placebo (DRUG), SAR441344 (DRUG).
Who is sponsoring clinical trial NCT04572841?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04572841's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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