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Monoclonal Antibodies
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active 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 from first dose of study treatment up to approximately 2 years
Awards & highlights
Pivotal Trial
Summary
This trial tests if an injection called secukinumab can help people with severe kidney problems caused by lupus. It aims to see if this treatment, combined with usual care, is safe and effective by calming the immune system to protect the kidneys. Secukinumab has shown sustained improvements in signs and symptoms of another autoimmune condition.
Eligible Conditions
- Lupus Nephritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study treatment up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study treatment up to approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52
Secondary study objectives
Average Daily Dose of Oral Corticosteroids
Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Mean Change From Baseline up to Week 52
+10 moreSide effects data
From 2020 Phase 3 trial • 86 Patients • NCT0303178231%
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%
Ligament sprain
7%
Contusion
7%
Pain in extremity
7%
Acne
6%
Joint injury
6%
Aphthous ulcer
6%
Conjunctivitis
6%
Influenza
6%
Abdominal pain upper
6%
Respiratory tract infection
5%
Paronychia
5%
Neutropenia
5%
Dyspepsia
5%
Impetigo
5%
Otitis media
5%
Arthropod bite
5%
Pruritus
5%
Psoriasis
5%
Rash
5%
Gastroenteritis
5%
Alanine aminotransferase increased
5%
Aspartate aminotransferase increased
3%
Vertigo
3%
Ear pain
3%
Fatigue
3%
Sinusitis
3%
Tracheitis
3%
Skin abrasion
3%
Musculoskeletal stiffness
3%
Skin papilloma
3%
Haematuria
3%
Respiratory disorder
3%
Alopecia
3%
Eczema
3%
Urticaria
3%
Oral herpes
3%
Radius fracture
3%
Injection site pain
3%
Gastrointestinal infection
3%
Pneumonia
3%
Transaminases increased
2%
Ligament rupture
2%
Injection site pruritus
2%
Iron deficiency anaemia
2%
Leukopenia
2%
Ocular hyperaemia
2%
Uveitis
2%
Constipation
2%
Mouth ulceration
2%
Toothache
2%
Nonalcoholic fatty liver disease
2%
Bronchitis
2%
Nail infection
2%
Viral upper respiratory tract infection
2%
Fall
2%
Road traffic accident
2%
Neutrophil count decreased
2%
Decreased appetite
2%
Arthritis
2%
Muscle contracture
2%
Myalgia
2%
Tendonitis
2%
Scrotal pain
2%
Dyspnoea
2%
Dermatitis
2%
Dermatitis contact
2%
Dry skin
2%
Ingrowing nail
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%
Pharyngotonsillitis
1%
Injection site reaction
1%
Muscle strain
1%
Neck pain
1%
Adenoiditis
1%
Gingival injury
1%
Osteochondrosis
1%
Venomous sting
1%
Ear disorder
1%
Postoperative wound infection
1%
Food poisoning
1%
Acute sinusitis
1%
Appendicitis
1%
Abdominal injury
1%
Juvenile psoriatic arthritis
1%
Cholesteatoma
1%
Adenoidal hypertrophy
1%
Anaemia
1%
Lymph node pain
1%
Lymphopenia
1%
Splenomegaly
1%
Sinus bradycardia
1%
Tachycardia
1%
Ventricular extrasystoles
1%
Gilbert's syndrome
1%
Hydrocele
1%
Myopia
1%
Abdominal distension
1%
Oral mucosal blistering
1%
Salivary hypersecretion
1%
Administration site reaction
1%
Feeling hot
1%
Injection site erythema
1%
Medical device pain
1%
Non-cardiac chest pain
1%
Pain
1%
Mite allergy
1%
Gastrointestinal viral infection
1%
Helminthic infection
1%
Herpes zoster
1%
Hordeolum
1%
Lower respiratory tract infection
1%
Nail bed infection
1%
Otitis externa
1%
Skin infection
1%
Tinea pedis
1%
Concussion
1%
Foot fracture
1%
Hand fracture
1%
Injection related reaction
1%
Overdose
1%
Tendon injury
1%
Thermal burn
1%
Blood uric acid increased
1%
Body temperature increased
1%
C-reactive protein increased
1%
Eosinophil count increased
1%
Hepatic enzyme increased
1%
Platelet count increased
1%
Hypercholesterolaemia
1%
Lactose intolerance
1%
Obesity
1%
Intervertebral disc disorder
1%
Jaw disorder
1%
Joint effusion
1%
Joint stiffness
1%
Muscle spasms
1%
Synovial cyst
1%
Papilloma
1%
Dizziness
1%
Nerve compression
1%
Tremor
1%
Visual field defect
1%
Anxiety
1%
Depressed mood
1%
Distractibility
1%
Euphoric mood
1%
Intentional self-injury
1%
Mental disorder
1%
Post-traumatic stress disorder
1%
Proteinuria
1%
Renal colic
1%
Gynaecomastia
1%
Menstruation irregular
1%
Testicular pain
1%
Epistaxis
1%
Haemoptysis
1%
Productive cough
1%
Rhinitis allergic
1%
Blister
1%
Diffuse alopecia
1%
Dyshidrotic eczema
1%
Hyperhidrosis
1%
Skin erosion
1%
Sexual abuse
1%
Cyanosis
1%
Acarodermatitis
1%
Seasonal allergy
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: secukinumabExperimental Treatment1 Intervention
A blinded, weekly, subcutaneous (s.c.) secukinumab 300 mg loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter.
Group II: placeboPlacebo Group2 Interventions
A blinded, weekly, subcutaneous (s.c.) matching placebo loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
secukinumab
2017
Completed Phase 3
~3610
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,412 Total Patients Enrolled
9 Trials studying Lupus Nephritis
1,385 Patients Enrolled for Lupus Nephritis
Media Library
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.