NCT06073093 (SPECIFI-RA) is a Phase 2 clinical trial of SAR441566 in Rheumatoid Arthritis, sponsored by Sanofi.

Who is sponsoring NCT06073093?

NCT06073093 is sponsored by Sanofi.

What drugs are being tested in NCT06073093?

Interventions in NCT06073093: SAR441566, Placebo.

What condition does NCT06073093 study?

NCT06073093 studies Rheumatoid Arthritis.

Is NCT06073093 still recruiting?

NCT06073093 is currently completed. Last updated 11 July 2025.

Last reviewed 2025-07-11 · How we verify

NCT06073093: SPECIFI-RA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 11 July 2025

What this trial tests

Phase 2 trial testing SAR441566 in Rheumatoid Arthritis in 264 participants. Completed in 2 July 2025.

Timeline

7 November 2023

Primary endpoint
18 June 2025

2 July 2025

Quick facts

Lead sponsor	Sanofi
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	264
Start date	7 November 2023
Primary completion	18 June 2025
Estimated completion	2 July 2025
Sites	102 locations across Japan, Mauritius, Poland, Mexico, Czechia, United States, South Africa, Slovakia

Drugs / interventions tested

SAR441566 — full drug profile →
Placebo

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Exploring TNFR1: from discovery to targeted therapy development.
Li Y, Ye R, Dai H, Lin J, et al · · 2025 · cited 33× · PMID 39815286 · DOI 10.1186/s12967-025-06122-0
Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.
Veerasubramanian PK, Wynn TA, Quan J, Karlsson FJ. · · 2024 · cited 26× · PMID 39297883 · DOI 10.1084/jem.20240806
Balinatunfib: A Clinical Oral Small Molecule TNFα Inhibitor.
Dömling A, Holak TA. · · 2025 · cited 2× · PMID 40537931 · DOI 10.1002/cmdc.202500258
Small-molecule inhibitors of the CD40-CD40L costimulatory interaction are effective in pancreatic islet transplantation and prevention of type 1 diabetes models.
Chuang ST, Alcazar O, Watts B, Abdulreda MH, et al · · 2024 · PMID 39606229 · DOI 10.3389/fimmu.2024.1484425

Verify or expand the search:

Other trials of SAR441566

Trials testing the same drug.

NCT06867094 — A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis · Phase 2 · recruiting
NCT06637631 — A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. · Phase 2 · recruiting
NCT06073119 — A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis · Phase 2 · completed
NCT05844735 — A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566 · Phase 1 · completed
NCT05858788 — A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adu · Phase 1 · completed

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06073093 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 11 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06073093.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing