Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Drug: SAR441344 IVDrug: Placebo IVDrug: SAR441344 SCDrug: Placebo SC
- Registration Number
- NCT05039840
- Lead Sponsor
- Sanofi
- Brief 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). Study details include:
* Study duration: 36 weeks
* Treatment duration: 24 weeks
* Visit frequency: every 2 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 116
- 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Frexalimab SAR441344 IV Frexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks Frexalimab SAR441344 SC Frexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks Placebo Placebo IV Placebo IV loading dose followed by SC, 24 weeks Placebo Placebo SC Placebo IV loading dose followed by SC, 24 weeks
- Primary Outcome Measures
Name Time Method Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24. 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.
- Secondary Outcome Measures
Name Time Method Percentage of participants achieving an SRI-4 response at week 24 with sustained reduction of oral corticosteroids At Week 24 Percentage of participants who achieved an SRI-4 response in prespecified biomarker (BM) subgroups at Week 24 At Week 24 Percentage of participants who achieved a BILAG-based Composite Lupus Assessment (BICLA) response in prespecified BM subgroups at Week 24 At Week 24 Total cumulative corticosteroid dose over 24 weeks Until Week 24 Percentage of participants with ≥50% improvement in CLASI-A at Week 24 in the subgroup of participants with baseline CLASI-A score ≥8 At Week 24 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) At Week 24 Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) from Baseline to Week 36 End of Study (EoS) Until Week 36 Participants with medically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation Until Week 36 Pharmacokinetic parameters: time to Cmax (tmax) Until Week 36 Pharmacokinetic parameters: area under the curve over the dosing interval (AUC0-tau) Until Week 36 Percentage of participants who achieved a BICLA response at Week 24 At Week 24 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 Until Week 24 Pharmacokinetic parameters: terminal half-life (t1/2z). Until Week 36 Measurement of anti-drug antibodies (ADA) (before administration at Week 0, 4, 8, 12, 16, 20, 24 and after treatment discontinuation at Week 36) Until Week 36 SAR441344 concentrations over time Until Week 36 Pharmacokinetic parameters: maximum concentration (Cmax) Until Week 36 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 At Week 24 Incidence of study investigational medicinal product permanent discontinuations and study withdrawals due to TEAEs from Baseline to Week 36 (EoS) Until Week 36
Trial Locations
- Locations (71)
Accel Research Sites Network - Birmingham- Site Number : 8400003
🇺🇸Birmingham, Alabama, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026
🇺🇸Chandler, Arizona, United States
Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022
🇺🇸Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027
🇺🇸Sun City, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023
🇺🇸Tucson, Arizona, United States
Saint John's Physician Partners- Site Number : 8400015
🇺🇸Santa Monica, California, United States
Millennium Clinical Trials - Simi Valley- Site Number : 8400004
🇺🇸Simi Valley, California, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002
🇺🇸DeBary, Florida, United States
Integral Rheumatology and Immunology Specialists- Site Number : 8400014
🇺🇸Plantation, Florida, United States
Infigo Clinical Research- Site Number : 8400016
🇺🇸Sanford, Florida, United States
Scroll for more (61 remaining)Accel Research Sites Network - Birmingham- Site Number : 8400003🇺🇸Birmingham, Alabama, United States