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History of Changes for Study: NCT05039840
Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus (APATURA)
Latest version (submitted May 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 1, 2021 None (earliest Version on record)
2 October 20, 2021 Recruitment Status, Study Status and Contacts/Locations
3 March 29, 2022 Study Status, Contacts/Locations and Eligibility
4 March 30, 2022 Study Status and IPDSharing
5 May 9, 2022 Study Status
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Study NCT05039840
Submitted Date:  September 1, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: ACT17010
Brief Title: Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus (APATURA)
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
Secondary IDs: 2021-001567-25 [EudraCT Number]
U1111-1266-5011 [Registry Identifier: ICTRP]
Open or close this module Study Status
Record Verification: September 2021
Overall Status: Not yet recruiting
Study Start: September 2021
Primary Completion: June 2023 [Anticipated]
Study Completion: September 2023 [Anticipated]
First Submitted: September 1, 2021
First Submitted that
Met QC Criteria:
September 1, 2021
First Posted: September 10, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
September 1, 2021
Last Update Posted: September 10, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Systemic Lupus Erythematosus
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 116 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SAR441344
SAR441344 intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks
Drug: SAR441344 IV
Pharmaceutical form: solution Route of administration: Intravenous infusion
Drug: SAR441344 SC
Pharmaceutical form: solution Route of administration: subcutaneous injection
Placebo Comparator: Placebo
Placebo IV loading dose followed by SC, 24 weeks
Drug: Placebo IV
Pharmaceutical form: solution Route of administration: Intravenous infusion
Drug: Placebo SC
Pharmaceutical form: solution Route of administration: subcutaneous injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. Percentage of participants who achieved an SRI-4 response in prespecified biomarker (BM) subgroups at Week 24
[ Time Frame: At Week 24 ]

2. 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 ]

3. Percentage of participants who achieved a BICLA response at Week 24
[ Time Frame: 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
[ Time Frame: Until Week 24 ]

5. Total cumulative corticosteroid dose over 24 weeks
[ Time Frame: Until Week 24 ]

6. Percentage of participants achieving an SRI-4 response at week 24 with sustained reduction of oral corticosteroids
[ Time Frame: 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
[ Time Frame: 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
[ Time Frame: 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)
[ Time Frame: 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)
[ Time Frame: Until Week 36 ]

11. 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 ]

12. Participants with medically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation
[ Time Frame: 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)
[ Time Frame: Until Week 36 ]

14. SAR441344 concentrations over time
[ Time Frame: Until Week 36 ]

15. Pharmacokinetic parameters: maximum concentration (Cmax)
[ Time Frame: Until Week 36 ]

16. Pharmacokinetic parameters: time to Cmax (tmax)
[ Time Frame: Until Week 36 ]

17. Pharmacokinetic parameters: area under the curve over the dosing interval (AUC0-tau)
[ Time Frame: Until Week 36 ]

18. Pharmacokinetic parameters: terminal half-life (t1/2z).
[ Time Frame: Until Week 36 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 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.

Open or close this module Contacts/Locations
Central Contact Person: Trial Transparency email recommended (Toll free number for US & Canada)
Telephone: 800-633-1610 Ext. option 6
Email: Contact-US@sanofi.com
Study Officials: Clinical Sciences & Operations
Study Director
Sanofi
Locations:
Open or close this module IPDSharing
Plan to Share IPD: 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://www.clinicalstudydatarequest.com/
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services