Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 84 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04572841
The ClinicalTrials.gov registry entry for NCT04572841 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04572841 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.