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Systemic Lupus ErythematosusPhase 2APATURANCT05039840

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

A Phase 2 study testing SAR441344 IV and SAR441344 SC in people with Systemic Lupus Erythematosus, run by Sanofi at 73 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
SAR441344 IV and SAR441344 SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
73 sitesin 16 countries
Study dates
10 Nov 2021to 24 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

73 sites in 16 countries.

73 sites in 16 countries

United States22 sites

  • Tekton Research - West Gate- Site Number : 8400001

    Austin, Texas, 78745

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

    Chandler, Arizona, 85225

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

    Colleyville, Texas, 76034

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

    DeBary, Florida, 32713

  • Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025

    Fort Worth, Texas, 76109

  • Prolato Clinical Research Center- Site Number : 8400005

    Houston, Texas, 77054

  • AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400024

    Irving, Texas, 75039

  • West Texas Clinical Research- Site Number : 8400018

    Lubbock, Texas, 79410

  • Vitalia Medical Research - Margate- Site Number : 8400039

    Margate, Florida, 33063

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

    Memphis, Tennessee, 38119

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

    Mesa, Arizona, 85210

  • Innovia Research Center- Site Number : 8400037

    Miramar, Florida, 33027

  • Columbia University Irving Medical Center- Site Number : 8400009

    New York, New York, 10032

  • RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013

    Oklahoma City, Oklahoma, 73116

  • Integral Rheumatology and Immunology Specialists- Site Number : 8400014

    Plantation, Florida, 33324

  • Infigo Clinical Research- Site Number : 8400016

    Sanford, Florida, 32771

  • Inspire Santa Fe Medical Group- Site Number : 8400019

    Santa Fe, New Mexico, 87505

  • Saint John's Physician Partners- Site Number : 8400015

    Santa Monica, California, 90404

  • Millennium Clinical Trials - Simi Valley- Site Number : 8400004

    Simi Valley, California, 93065

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

    Sun City, Arizona, 85351

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023

    Tucson, Arizona, 85748

  • Accel Research Sites Network - Birmingham- Site Number : 8400003

    Vestavia Hills, Alabama, 35216

Other trials in United States

Mexico8 sites

  • Investigational Site Number : 4840006

    Chihuahua City, 31000

  • Investigational Site Number : 4840011

    Chihuahua City, 31210

  • Investigational Site Number : 4840005

    Mérida, Yucatán, 97070

  • Investigational Site Number : 4840009

    Mexico City, Mexico City, 03100

  • Investigational Site Number : 4840004

    Mexico City, Mexico City, 06700

  • Investigational Site Number : 4840007

    Mexico City, 11850

  • Investigational Site Number : 4840001

    Monterrey, Nuevo León, 64460

  • Investigational Site Number : 4840008

    Veracruz, 91900

Other trials in Mexico

Argentina6 sites

  • Investigational Site Number : 0320008

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320006

    Buenos Aires, 1023

  • Investigational Site Number : 0320001

    Buenos Aires, 1111

  • Investigational Site Number : 0320004

    Buenos Aires, 1121

  • Investigational Site Number : 0320002

    Buenos Aires, 1430

  • Investigational Site Number : 0320003

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Brazil5 sites

  • Centro de Estudos em Terapias Inovadoras- Site Number : 0760002

    Curitiba, Paraná, 80030-110

  • LMK Servicos Medicos- Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006

    São José do Rio Preto, São Paulo, 15090-000

  • IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760007

    São Paulo, 04014-002

  • Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004

    São Paulo, 04265-000

Other trials in Brazil

Georgia5 sites

  • Investigational Site Number : 2680005

    Tbilisi, 0102

  • Investigational Site Number : 2680004

    Tbilisi, 0114

  • Investigational Site Number : 2680001

    Tbilisi, 0131

  • Investigational Site Number : 2680003

    Tbilisi, 0159

  • Investigational Site Number : 2680002

    Tbilisi, 0186

Other trials in Georgia

Greece5 sites

  • Investigational Site Number : 3000004

    Athens, 115 27

  • Investigational Site Number : 3000001

    Athens, 124 62

  • Investigational Site Number : 3000003

    Heraklion, 711 10

  • Investigational Site Number : 3000005

    Larissa, 415 00

  • Investigational Site Number : 3000002

    Thessaloniki, 546 36

Other trials in Greece

Chile4 sites

  • Investigational Site Number : 1520002

    Osorno, Los Lagos Region, 5311092

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7510047

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520003

    Talca, Maule Region, 3465584

Other trials in Chile

Spain4 sites

  • Investigational Site Number : 7240001

    Madrid, 28046

  • Investigational Site Number : 7240002

    Sabadell, Barcelona [Barcelona], 08208

  • Investigational Site Number : 7240005

    Valencia, 46014

  • Investigational Site Number : 7240004

    Valladolid, 47012

Other trials in Spain

Turkey (Türkiye)3 sites

  • Investigational Site Number : 7920003

    Ankara, 06800

  • Investigational Site Number : 7920002

    Denizli, 20070

  • Investigational Site Number : 7920004

    Sakarya, 54100

Other trials in Turkey (Türkiye)

Ukraine3 sites

  • Investigational Site Number : 8040006

    Kyiv, 02091

  • Investigational Site Number : 8040001

    Kyiv, 02125

  • Investigational Site Number : 8040005

    Poltava, 36011

Other trials in Ukraine

Hungary2 sites

  • Investigational Site Number : 3480002

    Gyula, 5700

  • Investigational Site Number : 3480003

    Székesfehérvár, 8000

Other trials in Hungary

Italy2 sites

  • IRCCS Ospedale San Raffaele-Site Number : 3800001

    Milan, Milano, 20132

  • Fondazione Policlinico Universitario Agostino Gemelli-Site Number : 3800002

    Rome, Roma, 00168

Other trials in Italy

Mauritius1 site

  • Investigational Site Number : 4800001

    Vacoas, 72218

Other trials in Mauritius

Puerto Rico1 site

  • GCM Medical Group - San Juan - Calle Jose Marti- Site Number : 8400011

    San Juan, 00917

Other trials in Puerto Rico

Russia1 site

  • Investigational Site Number : 6430002

    Moscow, 111539

Other trials in Russia

Switzerland1 site

  • Investigational Site Number : 7560001

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

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

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
Being tested
SAR441344 IV, SAR441344 SC, Placebo IV, Placebo SC
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR441344 IVDrug

    Pharmaceutical form: solution Route of administration: Intravenous infusion

  • SAR441344 SCDrug

    Pharmaceutical form: solution Route of administration: subcutaneous injection

  • Placebo IVDrug

    Pharmaceutical form: solution Route of administration: Intravenous infusion

  • Placebo SCDrug

    Pharmaceutical form: solution Route of administration: subcutaneous injection

Study groups in NCT05039840
Study groupRoleWhat they receive
FrexalimabExperimentalFrexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks
Receives: Drug: SAR441344 IV; Drug: SAR441344 SC
PlaceboPlacebo comparatorPlacebo IV loading dose followed by SC, 24 weeks
Receives: Drug: Placebo IV; Drug: Placebo SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24.

    A composite endpoint, with SRI-4 response requiring a ≥ 4-point improvement (reduction) from baseline in Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (hSELENA-SLEDAI), no new British Isles Lupus Assessment Group (BILAG-2004) A organ domain scores, or ≥ 2 new BILAG-2004 B organ domain scores compared with baseline, no worsening from baseline in lupus disease activity, and no permanent discontinuation of study drug or use of new or increased medication for SLE other than defined per protocol.

    Measured: At Week 24

Secondary outcomes (18)

  1. Percentage of participants who achieved an SRI-4 response in prespecified biomarker (BM) subgroups at Week 24

    Measured: At Week 24

  2. Percentage of participants who achieved a BILAG-based Composite Lupus Assessment (BICLA) response in prespecified BM subgroups at Week 24

    Measured: At Week 24

  3. Percentage of participants who achieved a BICLA response at Week 24

    Measured: At Week 24

  4. Percentage of participants whose prednisone dose was ≤ 7.5 mg at Week 16 and maintained through Week 24 in the subgroup with baseline prednisone ≥10 mg/day

    Measured: Until Week 24

  5. Total cumulative corticosteroid dose over 24 weeks

    Measured: Until Week 24

  6. Percentage of participants achieving an SRI-4 response at week 24 with sustained reduction of oral corticosteroids

    Measured: At Week 24

  7. Percent change from baseline in percentage in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-A at Week 24 in the subgroup of participants with baseline CLASI-A score ≥8

    Measured: At Week 24

  8. Percentage of participants with ≥50% improvement in CLASI-A at Week 24 in the subgroup of participants with baseline CLASI-A score ≥8

    Measured: At Week 24

  9. Percentage of participants with ≥50% improvement in the number of tender and swollen joints at Week 24 (among participants with at least 4 joints affected at baseline)

    Measured: At Week 24

  10. Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) from Baseline to Week 36 End of Study (EoS)

    Measured: Until Week 36

  11. Incidence of study investigational medicinal product permanent discontinuations and study withdrawals due to TEAEs from Baseline to Week 36 (EoS)

    Measured: Until Week 36

  12. Participants with medically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation

    Measured: Until Week 36

  13. Measurement of anti-drug antibodies (ADA) (before administration at Week 0, 4, 8, 12, 16, 20, 24 and after treatment discontinuation at Week 36)

    Measured: Until Week 36

  14. SAR441344 concentrations over time

    Measured: Until Week 36

  15. Pharmacokinetic parameters: maximum concentration (Cmax)

    Measured: Until Week 36

  16. Pharmacokinetic parameters: time to Cmax (tmax)

    Measured: Until Week 36

  17. Pharmacokinetic parameters: area under the curve over the dosing interval (AUC0-tau)

    Measured: Until Week 36

  18. Pharmacokinetic parameters: terminal half-life (t1/2z).

    Measured: Until Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2021
  2. Study start10 Nov 2021
  3. Primary completion4 Sep 2026
  4. Study completion24 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039840
Sponsor's protocol ID
ACT17010
Other IDs
U1111-1266-5011, 2023-508654-26, 2021-001567-25, 2023
Acronym
APATURA
Status last verified
Sep 2026
First submitted
1 Sep 2021
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.

    PubMed 39899371

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR441344 IV and SAR441344 SC in people with Systemic Lupus Erythematosus, run by Sanofi at 73 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Mexico, Argentina, Brazil, Georgia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24. (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05039840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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