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Monoclonal Antibodies

secukinumab for Lupus Nephritis (SELUNE Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52 to week 104
Awards & highlights

SELUNE Trial Summary

This trial is testing a new lupus nephritis treatment to see if it is more effective and safe than current treatments.

Eligible Conditions
  • Lupus Nephritis

SELUNE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52 to week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 to week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects achieving Complete Renal Response (CRR)
Secondary outcome measures
Average daily dose of oral corticosteroids
Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR)
Improvement in FACIT-Fatigue©
+10 more

Side effects data

From 2020 Phase 3 trial • 86 Patients • NCT03031782
31%
Nasopharyngitis
22%
Nausea
22%
Upper respiratory tract infection
20%
Diarrhoea
15%
Cough
14%
Arthralgia
14%
Headache
14%
Oropharyngeal pain
14%
Pyrexia
10%
Vomiting
10%
Pharyngitis
9%
Rhinitis
9%
Abdominal pain
8%
Tonsillitis
8%
Back pain
7%
Contusion
7%
Ligament sprain
7%
Pain in extremity
7%
Acne
6%
Aphthous ulcer
6%
Conjunctivitis
6%
Influenza
6%
Joint injury
6%
Abdominal pain upper
6%
Respiratory tract infection
5%
Psoriasis
5%
Dyspepsia
5%
Paronychia
5%
Neutropenia
5%
Impetigo
5%
Otitis media
5%
Arthropod bite
5%
Pruritus
5%
Rash
5%
Gastroenteritis
5%
Alanine aminotransferase increased
5%
Aspartate aminotransferase increased
3%
Vertigo
3%
Fatigue
3%
Ear pain
3%
Tracheitis
3%
Respiratory disorder
3%
Sinusitis
3%
Skin abrasion
3%
Musculoskeletal stiffness
3%
Eczema
3%
Skin papilloma
3%
Haematuria
3%
Alopecia
3%
Urticaria
3%
Oral herpes
3%
Radius fracture
3%
Injection site pain
3%
Gastrointestinal infection
3%
Pneumonia
3%
Transaminases increased
2%
Muscle contracture
2%
Ocular hyperaemia
2%
Leukopenia
2%
Iron deficiency anaemia
2%
Nonalcoholic fatty liver disease
2%
Constipation
2%
Uveitis
2%
Toothache
2%
Mouth ulceration
2%
Nail infection
2%
Injection site pruritus
2%
Bronchitis
2%
Viral upper respiratory tract infection
2%
Road traffic accident
2%
Fall
2%
Ligament rupture
2%
Tendonitis
2%
Neutrophil count decreased
2%
Decreased appetite
2%
Arthritis
2%
Myalgia
2%
Dermatitis contact
2%
Scrotal pain
2%
Dyspnoea
2%
Dermatitis
2%
Ingrowing nail
2%
Dry skin
2%
Urinary tract infection
2%
Viral infection
2%
Joint swelling
2%
Conjunctivitis allergic
2%
Peripheral swelling
2%
Folliculitis
2%
Respiratory tract infection viral
2%
Enthesopathy
2%
Dysmenorrhoea
2%
Asthma
2%
Rhinorrhoea
2%
Erythema
1%
Postoperative wound infection
1%
Cholesteatoma
1%
Food poisoning
1%
Juvenile psoriatic arthritis
1%
Acute sinusitis
1%
Anaemia
1%
Lymphopenia
1%
Ventricular extrasystoles
1%
Gilbert's syndrome
1%
Myopia
1%
Administration site reaction
1%
Non-cardiac chest pain
1%
Mite allergy
1%
Appendicitis
1%
Feeling hot
1%
Injection site reaction
1%
Lymph node pain
1%
Tendon injury
1%
Oral mucosal blistering
1%
Gastrointestinal viral infection
1%
Nail bed infection
1%
Blood uric acid increased
1%
Ear disorder
1%
Helminthic infection
1%
Splenomegaly
1%
Injection site erythema
1%
Sinus bradycardia
1%
Lower respiratory tract infection
1%
Tachycardia
1%
Abdominal injury
1%
Hydrocele
1%
Adenoidal hypertrophy
1%
Medical device pain
1%
Herpes zoster
1%
Hordeolum
1%
Pain
1%
Skin infection
1%
Tinea pedis
1%
Concussion
1%
Abdominal distension
1%
Salivary hypersecretion
1%
Injection related reaction
1%
Hypercholesterolaemia
1%
Hepatic enzyme increased
1%
Post-traumatic stress disorder
1%
Gingival injury
1%
Thermal burn
1%
Nerve compression
1%
Muscle strain
1%
Overdose
1%
Diffuse alopecia
1%
Lactose intolerance
1%
Otitis externa
1%
Pharyngotonsillitis
1%
Hand fracture
1%
Obesity
1%
Eosinophil count increased
1%
Joint stiffness
1%
Intentional self-injury
1%
Foot fracture
1%
Venomous sting
1%
Body temperature increased
1%
C-reactive protein increased
1%
Jaw disorder
1%
Muscle spasms
1%
Tremor
1%
Synovial cyst
1%
Anxiety
1%
Euphoric mood
1%
Platelet count increased
1%
Productive cough
1%
Intervertebral disc disorder
1%
Joint effusion
1%
Menstruation irregular
1%
Renal colic
1%
Blister
1%
Papilloma
1%
Haemoptysis
1%
Neck pain
1%
Distractibility
1%
Mental disorder
1%
Testicular pain
1%
Hyperhidrosis
1%
Skin erosion
1%
Visual field defect
1%
Depressed mood
1%
Proteinuria
1%
Dizziness
1%
Rhinitis allergic
1%
Osteochondrosis
1%
Epistaxis
1%
Sexual abuse
1%
Gynaecomastia
1%
Dyshidrotic eczema
1%
Cyanosis
1%
Acarodermatitis
1%
Seasonal allergy
1%
Adenoiditis
1%
Dysphagia
1%
Noninfective gingivitis
1%
Odynophagia
1%
Onychomycosis
1%
Pilonidal cyst
1%
Soft tissue infection
1%
Staphylococcal infection
1%
Vaginal infection
1%
Vulvovaginal mycotic infection
1%
Blood pressure systolic increased
1%
Blood triglycerides increased
1%
Liver function test increased
1%
Lymphocyte count decreased
1%
Pharyngeal erythema
1%
Skin plaque
1%
Hot flush
1%
Crohn's disease
1%
Eye haematoma
1%
Eye pain
1%
Functional gastrointestinal disorder
1%
Gastritis
1%
Gastrooesophageal reflux disease
1%
Lip disorder
1%
Malpositioned teeth
1%
Enterobiasis
1%
Oral viral infection
1%
Pulpitis dental
1%
Skin laceration
1%
Sunburn
1%
Blood alkaline phosphatase increased
1%
Blood calcium increased
1%
Blood creatinine increased
1%
Blood glucose increased
1%
Blood phosphorus increased
1%
Weight increased
1%
White blood cell count decreased
1%
White blood cells urine positive
1%
Groin pain
1%
Musculoskeletal chest pain
1%
Musculoskeletal pain
1%
Temporomandibular joint syndrome
1%
Epilepsy
1%
Varicocele
1%
Exfoliative rash
1%
Skin striae
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total
Placebo in TP2
AIN457 in Entire Treatment Period

SELUNE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: secukinumabExperimental Treatment1 Intervention
secukinumab 300 mg s.c.
Group II: placeboPlacebo Group1 Intervention
secukinumab placebo s.c.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
secukinumab
2017
Completed Phase 3
~2910

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,075 Total Patients Enrolled
7 Trials studying Lupus Nephritis
916 Patients Enrolled for Lupus Nephritis

Media Library

Lupus Nephritis Clinical Trial 2023: Secukinumab Highlights & Side Effects. Trial Name: NCT04181762 — Phase 3
Secukinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04181762 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be an eligible candidate to take part in this research?

"This clinical trial is looking for 460 patients with lupus nephritis who meet the following criteria: - Adult male and female subjects aged 18 - 75 years old at the time of Baseline- 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.- International Society of Neurology/Renal Pathology Society (ISN/RPS) Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)"

Answered by AI

For what purpose is secukinumab most commonly prescribed?

"secukinumab is most often used to treat ankylosing spondylitis, but it can also be used as a form of intervention for other conditions like psoriatic arthritis, enthesitis related arthritis (ERA), and severe plaque psoriasis."

Answered by AI

Could you share what past research has looked into secukinumab?

"secukinumab was first studied in 2014 at Attikon Hospital. As of right now, 110 clinical trials have been completed while 28 are still recruiting patients. A large majority of these 28 active trials are based in Milwaukee, Wisconsin."

Answered by AI

What is the chance that secukinumab will cause serious harm to patients?

"Although this is a Phase 3 trial, meaning that there is some data supporting efficacy, there have been multiple rounds of data supporting secukinumab's safety. Consequently, our team at Power has estimated the safety of secukinumab to be a 3."

Answered by AI

Can patients over the age of 40 participate in this experiment?

"The age range for patients that this study can accept is 18 to 75 years old."

Answered by AI

How many research centers are currently conducting this trial?

"In addition to the Novartis Investigative Site in Milwaukee, Wisconsin, and the IRIS Research and Development, LLC in Plantation, Florida, this clinical trial is also being run out of the Ahmed Arif Medical Research Center (AAMRC) in New york, Michigan, as well as 61 other locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
2020. "Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04181762.
~58 spots leftby Apr 2025
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