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NCT02748863: ALLURE

Study of Secukinumab With 2 mL Pre-filled Syringes

Completed Phase 3 Results posted Last updated 15 July 2019
What this trial tests

Phase 3 trial testing Placebo in Psoriasis in 214 participants. Completed in 8 June 2018.

Timeline
12 December 2016
Primary endpoint
8 August 2017
8 June 2018

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment214
Start date12 December 2016
Primary completion8 August 2017
Estimated completion8 June 2018
Sites52 locations across Russia, Belgium, United Kingdom, Germany, Poland, Canada, Spain, United States

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment Primary · 12 weeks

Number of participants who achieved ≥ 75% reduction in PASI compared to baseline PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area s

GroupValue95% CI
Secukinumab 2 mL PFS64
Placebo1
Participants With PASI 90 After 12 Weeks of Treatment Secondary · 12 weeks

Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline

GroupValue95% CI
Secukinumab 2 mL PFS48
Placebo1
Number of Participants With PASI 100 Response After 12 Weeks of Treatment Secondary · 12 weeks

Participants who achieved 100% reduction in PASI compared to baseline

GroupValue95% CI
Secukinumab 2 mL PFS28
Secukinumab 2 x 1 mL PFS26
Placebo0
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Secondary · up to week 52

PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline

Week 1 IGA 0/1
GroupValue95% CI
Secukinumab 2 mL PFS1
Secukinumab 2 x 1 mL PFS0
Placebo0
Secukinumab 2 mL PFS Following Placebo0
Secukinumab 2 x 1 mL PFS Following Placebo0
Week 1 PASI 50
GroupValue95% CI
Secukinumab 2 mL PFS5
Secukinumab 2 x 1 mL PFS5
Placebo1
Secukinumab 2 mL PFS Following Placebo0
Secukinumab 2 x 1 mL PFS Following Placebo1
Week 1 PASI 75
GroupValue95% CI
Secukinumab 2 mL PFS0
Secukinumab 2 x 1 mL PFS2
Placebo0
Secukinumab 2 mL PFS Following Placebo0
Secukinumab 2 x 1 mL PFS Following Placebo0
Week 1 PASI 90
GroupValue95% CI
Secukinumab 2 mL PFS0
Secukinumab 2 x 1 mL PFS0
Placebo0
Secukinumab 2 mL PFS Following Placebo0
Secukinumab 2 x 1 mL PFS Following Placebo0
Week 1 PASI 100
GroupValue95% CI
Secukinumab 2 mL PFS0
Secukinumab 2 x 1 mL PFS0
Placebo0
Secukinumab 2 mL PFS Following Placebo0
Secukinumab 2 x 1 mL PFS Following Placebo0
Week 2 IGA 0/1
GroupValue95% CI
Secukinumab 2 mL PFS2
Secukinumab 2 x 1 mL PFS1
Placebo1
Secukinumab 2 mL PFS Following Placebo0
Secukinumab 2 x 1 mL PFS Following Placebo1
Week 2 PASI 50
GroupValue95% CI
Secukinumab 2 mL PFS18
Secukinumab 2 x 1 mL PFS28
Placebo1
Secukinumab 2 mL PFS Following Placebo1
Secukinumab 2 x 1 mL PFS Following Placebo0
Week 2 PASI 75
GroupValue95% CI
Secukinumab 2 mL PFS4
Secukinumab 2 x 1 mL PFS5
Placebo0
Secukinumab 2 mL PFS Following Placebo0
Secukinumab 2 x 1 mL PFS Following Placebo0
Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment Primary · 12 weeks

The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline

GroupValue95% CI
Secukinumab 2 mL PFS55
Placebo1

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Secukinumab 300 mg (2mL PFS)
Serious: 0/72 (0%)
Deaths: 0/72
AIN457 300 mg (2x1mL PFS)
Serious: 1/71 (1%)
Deaths: 0/71
Placebo
Serious: 2/71 (3%)
Deaths: 0/71
Any AIN457 300 mg (2mL PFS)
Serious: 8/106 (8%)
Deaths: 0/106
Any Secukuinumab 300 mg (2x1mL PFS)
Serious: 5/105 (5%)
Deaths: 0/105
Any Secukinumab 300 mg
Serious: 13/211 (6%)
Deaths: 0/211

Serious adverse events (20 terms)

ReactionSystemSecukinumab 300 mg (2mL PFS)AIN457 300 mg (2x1mL PFS)PlaceboAny AIN457 300 mg (2mL PFS)Any Secukuinumab 300 mg (2…Any Secukinumab 300 mg
Colitis ulcerativeGastrointestinal disorders
Myocardial infarctionCardiac disorders
Crohn's diseaseGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
GastritisGastrointestinal disorders
Pancreatitis acuteGastrointestinal disorders
VomitingGastrointestinal disorders
AppendicitisInfections and infestations
DiverticulitisInfections and infestations
Pharyngitis bacterialInfections and infestations
Fibula fractureInjury, poisoning and procedural complications
Rib fractureInjury, poisoning and procedural complications
Diabetic ketoacidosisMetabolism and nutrition disorders
Psoriatic arthropathyMusculoskeletal and connective tissue disorders
Abortion spontaneousPregnancy, puerperium and perinatal conditions
DepressionPsychiatric disorders
HaemothoraxRespiratory, thoracic and mediastinal disorders
HypoventilationRespiratory, thoracic and mediastinal disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
Sleep apnoea syndromeRespiratory, thoracic and mediastinal disorders
Other adverse events (40 terms — click to expand)

ReactionSystemSecukinumab 300 mg (2mL PFS)AIN457 300 mg (2x1mL PFS)PlaceboAny AIN457 300 mg (2mL PFS)Any Secukuinumab 300 mg (2…Any Secukinumab 300 mg
NasopharyngitisInfections and infestations
HeadacheNervous system disorders
PruritusSkin and subcutaneous tissue disorders
DiarrhoeaGastrointestinal disorders
InfluenzaInfections and infestations
Upper respiratory tract infectionInfections and infestations
Back painMusculoskeletal and connective tissue disorders
FatigueGeneral disorders
RhinitisInfections and infestations
HypertensionVascular disorders
Respiratory tract infection viralInfections and infestations
CoughRespiratory, thoracic and mediastinal disorders
NauseaGastrointestinal disorders
FolliculitisInfections and infestations
Oral herpesInfections and infestations
PharyngitisInfections and infestations
ArthralgiaMusculoskeletal and connective tissue disorders
ConjunctivitisInfections and infestations
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
ToothacheGastrointestinal disorders
Injection site bruisingGeneral disorders
PyrexiaGeneral disorders
TonsillitisInfections and infestations
Ligament sprainInjury, poisoning and procedural complications
Alanine aminotransferase increasedInvestigations
MyalgiaMusculoskeletal and connective tissue disorders
RhinorrhoeaRespiratory, thoracic and mediastinal disorders
Injection site erythemaGeneral disorders
BronchitisInfections and infestations
HordeolumInfections and infestations
SinusitisInfections and infestations
Limb injuryInjury, poisoning and procedural complications
Weight increasedInvestigations
PsoriasisSkin and subcutaneous tissue disorders
Injection site pruritusGeneral disorders
Injection site swellingGeneral disorders
Vulvovaginal candidiasisInfections and infestations
Aspartate aminotransferase increasedInvestigations
HypercholesterolaemiaMetabolism and nutrition disorders

Most-reported serious reactions: Colitis ulcerative, Myocardial infarction, Crohn's disease, Diarrhoea, Gastritis, Pancreatitis acute, Vomiting, Appendicitis.

Data from ClinicalTrials.gov NCT02748863 adverse events section.

Sponsor's own description

The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Garcia-Doval I, Do G, et al · · 2017 · cited 106× · PMID 29271481 · DOI 10.1002/14651858.cd011535.pub2
  2. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2022 · cited 84× · PMID 35603936 · DOI 10.1002/14651858.cd011535.pub5
  3. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Afach S, Doney L, et al · · 2020 · cited 78× · PMID 31917873 · DOI 10.1002/14651858.cd011535.pub3
  4. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Guelimi R, Garcia-Doval I, et al · · 2023 · cited 67× · PMID 37436070 · DOI 10.1002/14651858.cd011535.pub6
  5. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2021 · cited 54× · PMID 33871055 · DOI 10.1002/14651858.cd011535.pub4
  6. Association of Secukinumab Treatment With Tuberculosis Reactivation in Patients With Psoriasis, Psoriatic Arthritis, or Ankylosing Spondylitis.
    Elewski BE, Baddley JW, Deodhar AA, Magrey M, et al · · 2021 · cited 51× · PMID 33001147 · DOI 10.1001/jamadermatol.2020.3257
  7. Efficacy, tolerability, patient usability, and satisfaction with a 2 mL pre-filled syringe containing secukinumab 300 mg in patients with moderate to severe plaque psoriasis: results from the phase 3 randomized, double-blind, placebo-controlled ALLURE study.
    Sigurgeirsson B, Schäkel K, Hong CH, Effendy I, et al · · 2022 · cited 15× · PMID 33896356 · DOI 10.1080/09546634.2021.1902925
  8. Understanding efficacy-safety balance of biologics in moderate-to-severe pediatric psoriasis.
    Golhen K, Winskill C, Theiler M, Buettcher M, et al · · 2022 · cited 6× · PMID 36226155 · DOI 10.3389/fmed.2022.944208

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