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Trial record 2 of 2 for:    secukinumab | lupus

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

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: NCT04181762
Recruitment Status : Not yet recruiting
First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 27, 2019
First Posted Date  ICMJE November 29, 2019
Last Update Posted Date November 29, 2019
Estimated Study Start Date  ICMJE February 28, 2020
Estimated Primary Completion Date September 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
Proportion of subjects achieving Complete Renal Response (CRR) [ Time Frame: Week 52 ]
Proportion of subjects achieving protocol-defined CRR
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) [ Time Frame: Week 52 ]
    Change from Baseline in 24-hour UPCR
  • Proportion of subjects achieving Partial Renal Response (PRR) [ Time Frame: Week 52 ]
    Proportion of subjects achieving protocol-defined PRR
  • Average daily dose of oral corticosteroids [ Time Frame: Week 16 to Week 52 ]
    Average daily dose of oral corticosteroids compared to placebo
  • Proportion of subjects achieving PRR [ Time Frame: Week 24 ]
    Proportion of subjects achieving PRR
  • Time to achieve CRR [ Time Frame: Baseline to Week 52 ]
    Time to achieve CRR
  • Time to achieve PRR [ Time Frame: Baseline to Week 52 ]
    Time to achieve PRR
  • Time to achieve UPCR ≤ 0.5 mg/mg [ Time Frame: Baseline to Week 52 ]
    Time to achieve first morning void UPCR ≤ 0.5 mg/mg
  • Improvement in FACIT-Fatigue© [ Time Frame: Baseline to Week 52 ]
    Improvement in FACIT-Fatigue© mean change of score compared to placebo
  • Improvement in SF-36 PCS mean [ Time Frame: Baseline to Week 52 ]
    Improvement in SF-36 PCS mean change compared to placebo
  • Improvement in LupusQoL Physical Health mean [ Time Frame: Baseline to Week 52 ]
    Improvement in LupusQoL Physical Health mean change of score compared to placebo
  • Incidence of Treatment-emergent AEs (TEAEs) / SAEs [ Time Frame: 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
  • Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 [ Time Frame: 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
  • Proportion of subjects with improved or maintained renal response at Week 104 [ Time Frame: 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
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 Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE Drug: secukinumab
STUDY DRUG
Other Name: AIN457
Study Arms  ICMJE
  • Experimental: secukinumab
    secukinumab 300 mg s.c.
    Intervention: Drug: secukinumab
  • Placebo Comparator: placebo
    secukinumab placebo s.c.
    Intervention: Drug: secukinumab
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2019)
460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2025
Estimated Primary Completion Date September 19, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  3. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04181762
Other Study ID Numbers  ICMJE CAIN457Q12301
2019-003211-57 ( EudraCT Number )
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date November 2019

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