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SELUNE: Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04181762
Collaborator
(none)
460
Enrollment
209
Locations
2
Arms
66.1
Anticipated Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to evaluate the efficacy and safety of subcutaneous secukinumab 300 mg compared to placebo, in combination with standard of care therapy (SoC), in subjects with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
460 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose:
Treatment
Official Title:
A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
Actual Study Start Date :
Jul 7, 2020
Anticipated Primary Completion Date :
Jan 14, 2025
Anticipated Study Completion Date :
Jan 8, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: secukinumab

secukinumab 300 mg s.c.

Drug: secukinumab
STUDY DRUG
Other Names:
  • AIN457

    		•
    Placebo Comparator: placebo

    secukinumab placebo s.c.

    Drug: secukinumab
    STUDY DRUG
    Other Names:
  • AIN457

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects achieving Complete Renal Response (CRR) [Week 52]

      Proportion of subjects achieving protocol-defined CRR

    Secondary Outcome Measures

    1. Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) [Week 52]

      Change from Baseline in 24-hour UPCR

    2. Proportion of subjects achieving Partial Renal Response (PRR) [Week 52]

      Proportion of subjects achieving protocol-defined PRR

    3. Average daily dose of oral corticosteroids [Week 16 to Week 52]

      Average daily dose of oral corticosteroids compared to placebo

    4. Proportion of subjects achieving PRR [Week 24]

      Proportion of subjects achieving PRR

    5. Time to achieve CRR [Baseline to Week 52]

      Time to achieve CRR

    6. Time to achieve PRR [Baseline to Week 52]

      Time to achieve PRR

    7. Time to achieve UPCR ≤ 0.5 mg/mg [Baseline to Week 52]

      Time to achieve first morning void UPCR ≤ 0.5 mg/mg

    8. Improvement in FACIT-Fatigue© [Baseline to Week 52]

      Improvement in FACIT-Fatigue© mean change of score compared to placebo

    9. Improvement in SF-36 PCS mean [Baseline to Week 52]

      Improvement in SF-36 PCS mean change compared to placebo

    10. Improvement in LupusQoL Physical Health mean [Baseline to Week 52]

      Improvement in LupusQoL Physical Health mean change of score compared to placebo

    11. Incidence of Treatment-emergent AEs (TEAEs) / SAEs [Baseline to Week 52]

      Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology

    12. Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 [Week 52 to Week 104]

      Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group

    13. Proportion of subjects with improved or maintained renal response at Week 104 [Week 52 to Week 104]

      Estimate the proportion of subjects with improved or maintained response (PRR or CRR) in subjects who had achieved at least PRR at Week 52 in the secukinumab group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Adult male and female subjects aged 18 - 75 years old at the time of Baseline.

    2. Confirmed diagnosis of:

    • SLE as defined by the American College of Rheumatology (ACR), OR

    • LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies.

    1. Active lupus nephritis:

    • International Society of Neurology/Renal Pathology Society (ISN/RPS) Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; subjects are permitted to have co-existing Class V.

    • UPCR ≥1 at Screening.

    • Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2.

    • Active urinary sediment.

    Exclusion Criteria:

    1. Severe renal impairment and subjects requiring dialysis dialysis within the previous 12 months before Screening.

    2. Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE).

    3. Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline.

    4. Active ongoing inflammatory diseases.

    5. Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor.

    6. Ongoing infections or malignant process.

    7. Pregnant or lactating women.

    Other inclusion and exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Alabama United States 35294
    2 Medvin Clinical Research Covina California United States 91722
    3 Kaiser Permanente Fontana Fontana California United States 92335
    4 Purushotham & Akther Kotha, MD La Mesa California United States 91942
    5 Loma Linda University Loma Linda California United States 92354
    6 Novartis Investigational Site /UCLA Division of Rheumatology Los Angeles California United States 90095
    7 Novartis Investigative Site Los Angeles California United States 90095
    8 Chander Medical Associates S. Gate California United States 90280
    9 Novartis Investigative Site S. Gate California United States 90280
    10 Center for Innovative Therapy San Diego California United States 92037
    11 Millennium Clinical Trials Thousand Oaks California United States 91360
    12 Novartis Investigative Site Thousand Oaks California United States 91360
    13 Inland Rheumatology Clinical Trials Upland California United States 91786
    14 Novartis Investigative Site Van Nuys California United States 91405
    15 Hartford Healthcare Hartford Connecticut United States 06106
    16 Novartis Investigative Site Aventura Florida United States 33180
    17 Arthritis and Rheum Ctr of S. Florida Margate Florida United States 33063
    18 Center for Arthritis and Rheumatic Diseases Miami Florida United States 33173
    19 IRIS Research and Development, LLC Plantation Florida United States 33324
    20 Piedmont Healthcare Atlanta Georgia United States 30318
    21 Qualmedica Research dba Pedia Research Evansville Indiana United States 47715
    22 Tufts Medical Center Boston Massachusetts United States 02111
    23 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    24 Ahmed Arif Medical Research Center (AAMRC) Grand Blanc Michigan United States 48439
    25 NYU Langone Ambulatory Care Brooklyn Heights Brooklyn New York United States 11201
    26 Feinstein Institute for Medical Research-Northwell Health Manhasset New York United States 11030
    27 Novartis Investigational Site /Hospital for Special Surgery New York New York United States 10021
    28 Novartis Investigative Site Syracuse New York United States 13210
    29 Novartis Investigative Site Statesville North Carolina United States 28625
    30 Oklahoma Medical Research Foundation Rheumatology Center of Excellence Oklahoma City Oklahoma United States 73104
    31 Temple University Hospital Philadelphia Pennsylvania United States 19140
    32 Novartis Investigational Site /Medical University of South Carolina (MUSC) Charleston South Carolina United States 28425
    33 Amarillo Center for Clinical Research Amarillo Texas United States 79016
    34 Precision Comprehensive Clinical Research Solutions Colleyville Texas United States 76034
    35 Novartis Investigative Site El Paso Texas United States 79902
    36 Novartis Investigational Site /Texas Arthritis Center El Paso Texas United States 97712
    37 Prolato Clinical Research Center Houston Texas United States 77054
    38 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    39 Novartis Investigative Site Caba Buenos Aires Argentina C1280AEB
    40 Novartis Investigative Site Ciudad Autonoma de Bs As Buenos Aires Argentina C1015ABO
    41 Novartis Investigative Site Buenos Aires Argentina C1012AAR
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    45 Novartis Investigative Site Murdoch Western Australia Australia 6150
    46 Novartis Investigative Site Fortaleza CE Brazil 60430 370
    47 Novartis Investigative Site Belo Horizonte MG Brazil 30150-221
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    50 Novartis Investigative Site Joinville Santa Catarina Brazil 893227-680
    51 Novartis Investigative Site Santo Andre SP Brazil 09060-870
    52 Novartis Investigative Site Santo Andre SP Brazil 09090-790
    53 Novartis Investigative Site Sao Paulo SP Brazil 05403 000
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    187 Novartis Investigative Site Linkoping Sweden SE 581 85
    188 Novartis Investigative Site Stockholm Sweden 171 76
    189 Novartis Investigative Site Uppsala Sweden 751 85
    190 Novartis Investigative Site Bern Switzerland 3010
    191 Novartis Investigative Site Lausanne Switzerland 1005
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    193 Novartis Investigative Site Zuerich Switzerland 8091
    194 Novartis Investigative Site Kaohsiung Taiwan 81346
    195 Novartis Investigative Site Taichung Taiwan 40447
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    197 Novartis Investigative Site Taoyuan Taiwan 333
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    199 Novartis Investigative Site Bangkok Thailand 10400
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    201 Novartis Investigative Site Istanbul Turkey 34093
    202 Novartis Investigative Site Istanbul Turkey 34147
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    206 Novartis Investigative Site London United Kingdom SE1 7EH
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    208 Novartis Investigative Site Hanoi Vietnam 100000
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    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04181762
    Other Study ID Numbers:
    • CAIN457Q12301
    • 2019-003211-57
    First Posted:
    Nov 29, 2019
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    SLE
    LN
    secukinumab
    renal biopsy
    eGFR
    UPCR
    SoC background therapy
    Additional relevant MeSH terms:
    Nephritis
    Lupus Nephritis

    Study Results

    No Results Posted as of Aug 23, 2022