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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05039840
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE September 1, 2021
First Posted Date  ICMJE September 10, 2021
Last Update Posted Date May 10, 2022
Actual Study Start Date  ICMJE November 10, 2021
Estimated Primary Completion Date February 26, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2021)
Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2021)
  • Percentage of participants who achieved an SRI-4 response in prespecified biomarker (BM) subgroups at Week 24 [ Time Frame: At Week 24 ]
  • Percentage of participants who achieved a BILAG-based Composite Lupus Assessment (BICLA) response in prespecified BM subgroups at Week 24 [ Time Frame: At Week 24 ]
  • Percentage of participants who achieved a BICLA response at Week 24 [ Time Frame: 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 [ Time Frame: Until Week 24 ]
  • Total cumulative corticosteroid dose over 24 weeks [ Time Frame: Until Week 24 ]
  • Percentage of participants achieving an SRI-4 response at week 24 with sustained reduction of oral corticosteroids [ Time Frame: At Week 24 ]
  • 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 [ Time Frame: At 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Until Week 36 ]
  • Incidence of study investigational medicinal product permanent discontinuations and study withdrawals due to TEAEs from Baseline to Week 36 (EoS) [ Time Frame: Until Week 36 ]
  • Participants with medically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation [ Time Frame: 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) [ Time Frame: Until Week 36 ]
  • SAR441344 concentrations over time [ Time Frame: Until Week 36 ]
  • Pharmacokinetic parameters: maximum concentration (Cmax) [ Time Frame: Until Week 36 ]
  • Pharmacokinetic parameters: time to Cmax (tmax) [ Time Frame: Until Week 36 ]
  • Pharmacokinetic parameters: area under the curve over the dosing interval (AUC0-tau) [ Time Frame: Until Week 36 ]
  • Pharmacokinetic parameters: terminal half-life (t1/2z). [ Time Frame: Until Week 36 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus
Official Title  ICMJE Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: SAR441344 IV
    Pharmaceutical form: solution Route of administration: Intravenous infusion
  • Drug: SAR441344 SC
    Pharmaceutical form: solution Route of administration: subcutaneous injection
  • Drug: Placebo IV
    Pharmaceutical form: solution Route of administration: Intravenous infusion
  • Drug: Placebo SC
    Pharmaceutical form: solution Route of administration: subcutaneous injection
Study Arms  ICMJE
  • Experimental: SAR441344
    SAR441344 intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks
    Interventions:
    • Drug: SAR441344 IV
    • Drug: SAR441344 SC
  • Placebo Comparator: Placebo
    Placebo IV loading dose followed by SC, 24 weeks
    Interventions:
    • Drug: Placebo IV
    • Drug: Placebo SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2021)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 20, 2024
Estimated Primary Completion Date February 26, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion 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.

Exclusion Criteria:

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com
Listed Location Countries  ICMJE Argentina,   Chile,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05039840
Other Study ID Numbers  ICMJE ACT17010
2021-001567-25 ( EudraCT Number )
U1111-1266-5011 ( Registry Identifier: ICTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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
Current Responsible Party Sanofi
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sanofi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP