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NCT06073093 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

A Phase 2 study, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
264
Enrollment target

NCT06073093 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 264 participants.

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The verdict

NCT06073093, a Phase 2 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
264 participants
Enrollment target

Study Summary

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (4 to 6 weeks) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

Interventions

  • DRUG Placebo
  • DRUG SAR441566

Trial Details

FieldValue
Enrollment Target 264 participants
Start Date 2023-11-07
Est. Completion 2025-07-02
Phase Phase 2

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT06073093

The ClinicalTrials.gov registry entry for NCT06073093 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 264 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.

NCT06073093 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06073093 about?

NCT06073093 is a clinical study titled "A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis". This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult parti...

What is the current status of trial NCT06073093?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2023-11-07. Estimated completion is 2025-07-02.

What interventions are being tested in trial NCT06073093?

The interventions under investigation include: Placebo (DRUG), SAR441566 (DRUG).

Who is sponsoring clinical trial NCT06073093?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.