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NCT02362789: PSORITUS

Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

Completed Phase 3 Results posted Last updated 28 December 2018
What this trial tests

Phase 3 trial testing Secukinumab in Psoriasis in 132 participants. Completed in 15 July 2016.

Timeline
4 January 2015
Primary endpoint
15 July 2016
15 July 2016

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment132
Start date4 January 2015
Primary completion15 July 2016
Estimated completion15 July 2016
Sites19 locations across Germany

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.

Pruritus Intensity Visual Analogue Scale Score at Week 32 Primary · Week 32

On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus.

GroupValue95% CI
Secukinumab8.8± 4.7
Placebo27.1± 4.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year, 3 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Run-In
Serious: 6/130 (5%)
Deaths: —
Secukinumab
Serious: 2/42 (5%)
Deaths: —
Placebo
Serious: 0/38 (0%)
Deaths: —

Serious adverse events (11 terms)

ReactionSystemRun-InSecukinumabPlacebo
ACUTE MYOCARDIAL INFARCTIONCardiac disorders———
MYOCARDIAL INFARCTIONCardiac disorders———
CROHN'S DISEASEGastrointestinal disorders———
PANCREATITIS ACUTEGastrointestinal disorders———
CHOLELITHIASISHepatobiliary disorders———
ERYSIPELASInfections and infestations———
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASEInfections and infestations———
URINARY TRACT INFECTIONInfections and infestations———
HUMERUS FRACTUREInjury, poisoning and procedural complications———
LIGAMENT RUPTUREInjury, poisoning and procedural complications———
ANEURYSM RUPTUREDVascular disorders———
Other adverse events (8 terms — click to expand)

ReactionSystemRun-InSecukinumabPlacebo
NASOPHARYNGITISInfections and infestations———
BACK PAINMusculoskeletal and connective tissue disorders———
HEADACHENervous system disorders———
ABDOMINAL PAIN UPPERGastrointestinal disorders———
INFLUENZAInfections and infestations———
RHINITISInfections and infestations———
SINUSITISInfections and infestations———
HYPERTENSIONVascular disorders———

Most-reported serious reactions: ACUTE MYOCARDIAL INFARCTION, MYOCARDIAL INFARCTION, CROHN'S DISEASE, PANCREATITIS ACUTE, CHOLELITHIASIS, ERYSIPELAS, INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE, URINARY TRACT INFECTION.

Data from ClinicalTrials.gov NCT02362789 adverse events section.

Sponsor's own description

The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.

Publications & conference data

6 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, Doney L, et al · · 2022 · cited 84× · PMID 35603936 · DOI 10.1002/14651858.cd011535.pub5
  2. 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
  3. 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
  4. 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
  5. 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
  6. Secukinumab Reduces Psoriasis-associated Pruritus and Regenerates the Cutaneous Nerve Architecture: Results from PSORITUS a Doubleblind, Placebo-controlled, Randomized Withdrawal Phase IIIb Study.
    Renkhold L, Pereira MP, Pereira MP, Loser K, et al · · 2024 · cited 2× · PMID 39565228 · DOI 10.2340/actadv.v104.40737

Verify or expand the search:

Other trials of Secukinumab

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Other Novartis Pharmaceuticals trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02362789.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing