RECRUITING

Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study

Quick Facts

Study Start:2021-11-10

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05039840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria * Positive antinuclear antibody (ANA) (titer ≥1:80) during screening * Positivity for at least one serological characteristic * Total hSELENA-SLEDAI score ≥6 (including points attributed from arthritis and rash) during screening and at least 4 points from clinical features at randomization as confirmed by a Sponsor-selected independent reviewer(s) * At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s) * Receiving at least one of the standard of care (SOC) for SLE (combination is possible) * Body weight within 45 kg to 120 kg (inclusive) at screening * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.	* Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessments * Active and severe lupus nephritis * Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis * Known or suspected drug-induced lupus * History, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment * History or current hypogammaglobulinemia * Serious systemic viral, bacterial or fungal infection * Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution * Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest Xrays) and examination, and tuberculosis testing * High dose of steroids, or a change in dose within 4 weeks prior to randomization * High dose of antimalarial, or a change in dose within 12 weeks prior to randomization * High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization * Use of cyclophosphamide within 3 months prior to screening * Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization * Participants likely to require multiple courses of oral corticosteroid (OCS) during the study for chronic diseases other than SLE * Administration of any live (attenuated) vaccine within 3 months prior to randomization (eg, varicella zoster vaccine, oral polio, rabies) * Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4 weeks prior to randomization

Inclusion Criteria

Exclusion Criteria

* Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria
* Positive antinuclear antibody (ANA) (titer ≥1:80) during screening
* Positivity for at least one serological characteristic
* Total hSELENA-SLEDAI score ≥6 (including points attributed from arthritis and rash) during screening and at least 4 points from clinical features at randomization as confirmed by a Sponsor-selected independent reviewer(s)
* At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s)
* Receiving at least one of the standard of care (SOC) for SLE (combination is possible)
* Body weight within 45 kg to 120 kg (inclusive) at screening
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

* Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessments
* Active and severe lupus nephritis
* Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis
* Known or suspected drug-induced lupus
* History, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment
* History or current hypogammaglobulinemia
* Serious systemic viral, bacterial or fungal infection
* Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution
* Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest Xrays) and examination, and tuberculosis testing
* High dose of steroids, or a change in dose within 4 weeks prior to randomization
* High dose of antimalarial, or a change in dose within 12 weeks prior to randomization
* High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization
* Use of cyclophosphamide within 3 months prior to screening
* Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization
* Participants likely to require multiple courses of oral corticosteroid (OCS) during the study for chronic diseases other than SLE
* Administration of any live (attenuated) vaccine within 3 months prior to randomization (eg, varicella zoster vaccine, oral polio, rabies)
* Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4 weeks prior to randomization

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

800-633-1610

contact-us@sanofi.com

Principal Investigator

Clinical Sciences & Operations

STUDY_DIRECTOR

Sanofi

Study Locations (Sites)

Accel Research Sites Network - Birmingham- Site Number : 8400003

Birmingham, Alabama, 35216

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026

Chandler, Arizona, 85225

United States

Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022

Mesa, Arizona, 85210

United States

Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027

Sun City, Arizona, 85351

United States

Arizona Arthritis & Rheumatology Associates- Site Number : 8400023

Tucson, Arizona, 85748

United States

Saint John's Physician Partners- Site Number : 8400015

Santa Monica, California, 90404

United States

Millennium Clinical Trials- Site Number : 8400004

Simi Valley, California, 93065

United States

Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002

DeBary, Florida, 32713

United States

Integral Rheumatology and Immunology Specialists- Site Number : 8400014

Plantation, Florida, 33324

United States

Infigo Clinical Research- Site Number : 8400016

Sanford, Florida, 32771

United States

Sahni Rheumatology & Therapy, PC- Site Number : 8400021

West Long Branch, New Jersey, 07764

United States

Inspire Santa Fe Medical Group- Site Number : 8400019

Santa Fe, New Mexico, 87505

United States

Columbia University Irving Medical Center- Site Number : 8400009

New York, New York, 10032

United States

RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013

Oklahoma City, Oklahoma, 73116

United States

Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008

Memphis, Tennessee, 38119

United States

Tekton Research - West Gate- Site Number : 8400001

Austin, Texas, 78745

United States

Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017

Colleyville, Texas, 76034

United States

Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025

Fort Worth, Texas, 76109

United States

Prolato Clinical Research Center- Site Number : 8400005

Houston, Texas, 77054

United States

Lone Star Arthritis & Rheumatology Associates- Site Number : 8400024

Irving, Texas, 75039

United States

West Texas Clinical Research- Site Number : 8400018

Lubbock, Texas, 79410

United States

Collaborators and Investigators

Sponsor: Sanofi

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-10

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2021-11-10

Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus