Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
Active, not recruiting · Phase 2 · NCT05039840
Conditions: Systemic Lupus Erythematosus
At a glance
- Research payments reported, 2025
- $412,657
- U.S. investigators named
- 17
- Sites paid
- 13
- Planned or actual enrollment
- 109
About the trial
- Sponsor
- Sanofi
- Tested
- SAR441344 IV (drug), SAR441344 SC (drug), Placebo IV (drug), Placebo SC (drug)
- Dates
- Started 2021-11-10; completion 2026-11-24
- Results posted
- Not yet
This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18 to 70 years with active Systemic Lupus Erythematosus (SLE). Study details include: * Study duration: 36 weeks * Treatment duration: 24 weeks * Visit frequency: every 2 weeks
From ClinicalTrials.gov, last updated 2026-09-22. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $412,657 in research payments for this study in 2025 (106 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Amer Al-khoudari, M.D. Rheumatology · Chandler, AZ
- Jeffrey B. Loomer, MD Rheumatology · Tucson, AZ
- Nehad Soloman, M.D. Rheumatology · Phoenix, AZ
- Areena Swarup, MD Rheumatology · Mesa, AZ
- Elvira A. Lindwall, M.D. Rheumatology · Thousand Oaks, CA
- Orrin M. Troum, MD Rheumatology · Santa Monica, CA
- Kwabena Ayesu, MD Internal Medicine · Orlando, FL
- Emilio Pando, MD Internal Medicine · Miramar, FL
- Clifford Stermer, M.D. Rheumatology · Palm Beach Gardens, FL
- Guillermo J. Valenzuela, MD Specialist · Plantation, FL
- Hillary E. Norton, M.D. Rheumatology · Santa Fe, NM
- Latisha D. Heinlen, MD Rheumatology · Oklahoma City, OK
- Karina Vila-rivera, M.D. Rheumatology · San Juan, PR
- Shariq I. Chudhri, D.O. Rheumatology · Fort Worth, TX
- Himabindu R. Reddy, MD Rheumatology · Fort Worth, TX
- Jitendra I. Vasandani, MD Rheumatology · Lubbock, TX
- Biruh Workeneh, MD Nephrology (Kidney) · Houston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Gcm Medical Group Psc $70,895
- Jitendra Vasandani MD PA Jitendra Vasandani MD PA Dba West Texas Clinical Research $68,876
- Rao Research Llc $38,759
- Hillary E Norton MD PC Inspire Santa Fe Medical Group $37,760
- Iris Research and Development LLC $32,000
- Arizona Arthritis Rheumatology Research PLLC $30,616
- Prolato Research Llc $26,839
- Hernandez and Trujillo Llc $25,000
- Sonia Martinez Innovia Research Center Inc $23,721
- Providence Health System Southern California Dba P $16,475
- Providence Health System Southern C $16,475
- $14,741
- Millennium Clinical Trials Llc $7,842
- Omega Research Debary Llc $2,658
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.