Evidence map›Paper›PMID 41092316›Full record

Trial reportRheumatology (Oxford, England)2026

Secukinumab in active lupus nephritis: results from a phase III randomized, placebo-controlled study (SELUNE) and an open-label extension study.

Ming-Hui Zhao, Fidencio Cons Molina, Gustavo Aroca, Maria G Tektonidou, Anubhav Mathur, Radhika Tangadpalli, Rui Sun, Ruvie Martin, Pascale Pellet, Thao Ngoc Phuong Huynh

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04181762 phase3terminatednot on this map

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

TypeinterventionalSponsorNovartis PharmaceuticalsRan2020 to 2023Enrolled275ConditionsLupus NephritisArmssecukinumab, Placebo
NCT05232864 phase3terminatednot on this map

A Three-year, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability in Patients With Active Lupus Nephritis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2022 to 2023Enrolled31ConditionsLupus NephritisArmsSecukinumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Ming-Hui ZhaoRenal Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, China.
Fidencio Cons MolinaCentro de Investigación en Artritis y Osteoporosis, Mexicali, Mexico.
Gustavo ArocaRenal Division, Simon Bolivar University, Barranquilla, Colombia.
Maria G TektonidouRheumatology Unit, Joint Academic Rheumatology Program, First Department of Propaedeutic and Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.ORCID 0000-0003-2238-0975
Anubhav MathurNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Radhika TangadpalliNovartis Healthcare Private Limited, Hyderabad, India.
Rui SunNovartis Pharmaceuticals Corporation, Bannockburn, IL, USA.
Ruvie MartinNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Pascale PelletNovartis Pharma AG, Basel, Switzerland.ORCID 0009-0009-1021-3361
Thao Ngoc Phuong HuynhNephrology and Hemodialysis Department, University Medical Center Ho Chi Minh City, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.

Funding

Novartis Pharma AG, Basel, Switzerland
6 · The paper itself

Abstract

objectiveThe objective of this study was to evaluate the efficacy and safety of s.c. secukinumab 300 mg combined with standard of care (SoC) in adult patients with active LN.

methodsThe core study was a phase III randomized, placebo-controlled, double-blind study (planned duration: 104 weeks) of patients with active LN. Eligible patients were randomized to receive secukinumab 300 mg or placebo for the first 4 weeks, followed by a monthly maintenance dose, with all patients receiving a SoC background regimen. Patients completing the 104-week treatment of the core study were eligible for an open-label extension study (planned duration: up to 260 weeks) to receive secukinumab 300 mg every 4 weeks. The primary end point of the core study was the proportion of patients achieving complete renal response (CRR) at week 52.

resultsBoth studies were terminated early, following a planned futility analysis in the core study that showed no clinically meaningful benefit of secukinumab over placebo. In the core study, the proportion of patients achieving CRR at week 52 was lower after receiving secukinumab (24.2%) than after receiving the placebo (36.3%). No differences were observed between the secukinumab and placebo groups in any of the secondary end points of the core study. The incidence of treatment-emergent adverse events was comparable between the secukinumab and placebo groups. In the extension study, the results were not interpretable, owing to the low patient number included in the data analysis (n = 31).

conclusionSecukinumab did not demonstrate superior efficacy over placebo in patients with active LN. Secukinumab was well-tolerated with no new or unexpected safety signals detected.

trial registrationhttps://clinicaltrials.gov/study/NCT04181762, NCT04181762 (Novartis study code: CAIN457Q12301). https://www.clinicaltrials.gov/study/NCT05232864, NCT05232864 (Novartis study code: CAIN457Q12301E1).

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedLupus NephritisAdultDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedsecukinumabautoimmunitybiologic therapiesclinical trials and methodsinterventional studiesrenalsystemic lupus erythematosus

Identifiers

PMID41092316
PMCPMC12862366

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.