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NCT02826603: CLARITY

Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

Completed Phase 3 Results posted Last updated 9 July 2019
What this trial tests

Phase 3 trial testing Secukinumab in Plaque Psoriasis in 1,114 participants. Completed in 9 July 2018.

Timeline
22 June 2016
Primary endpoint
9 July 2018
9 July 2018

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment1,114
Start date22 June 2016
Primary completion9 July 2018
Estimated completion9 July 2018
Sites154 locations across Slovakia, Malaysia, Vietnam, Hungary, Poland, South Korea, Canada, Guatemala

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Plaque 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 Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Primary · Week 12

Number of participants who achieved ≥ 90% reduction in PASI compared to baseline. Logistic regression analysis of PASI 90 response at Week 12 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, upper limbs, trunk, lower limbs; 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) t

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)366
Ustekinumab 2 x 45mg or 90mg265
Participants With IGA Mod 2011 0 or 1 at Week 12 Primary · Week 12

Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)397
Ustekinumab 2 x 45mg or 90mg306
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 Secondary · Week 12

Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)484
Ustekinumab 2 x 45mg or 90mg409
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 Secondary · Week 4

Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)221
Ustekinumab 2 x 45mg or 90mg90
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 Secondary · Week 16

Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)250
Ustekinumab 2 x 45mg or 90mg147
Participants With IGA Mod 2011 0 or 1 at 16 Weeks Secondary · Week 16

Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)432
Ustekinumab 2 x 45mg or 90mg326
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12 Secondary · Week 12

Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)210
Ustekinumab 2 x 45mg or 90mg111
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 Secondary · Week 16

Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)506
Ustekinumab 2 x 45mg or 90mg441
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 Secondary · Week 16

Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)423
Ustekinumab 2 x 45mg or 90mg299
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52 Secondary · Week 52

Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.

GroupValue95% CI
Secukinumab 300mg (2 x 150 mg)402
Ustekinumab 2 x 45mg or 90mg330

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 months. 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.

AIN457 300 mg
Serious: 29/550 (5%)
Deaths: 2/550
UST 45/90 mg
Serious: 21/552 (4%)
Deaths: 0/552
All Patients
Serious: 50/1102 (5%)
Deaths: 2/1102

Serious adverse events (64 terms)

ReactionSystemAIN457 300 mgUST 45/90 mgAll Patients
Atrial fibrillationCardiac disorders
CellulitisInfections and infestations
Acute respiratory failureRespiratory, thoracic and mediastinal disorders
Deep vein thrombosisVascular disorders
Ventricular tachycardiaCardiac disorders
Dengue feverInfections and infestations
LymphadenopathyBlood and lymphatic system disorders
Angina pectorisCardiac disorders
Myocardial ischaemiaCardiac disorders
Anal fissureGastrointestinal disorders
Colitis erosiveGastrointestinal disorders
Colitis ulcerativeGastrointestinal disorders
HaemorrhoidsGastrointestinal disorders
Pancreatitis acuteGastrointestinal disorders
Sudden cardiac deathGeneral disorders
CholecystitisHepatobiliary disorders
Anaphylactic reactionImmune system disorders
Drug hypersensitivityImmune system disorders
BronchitisInfections and infestations
Clostridium difficile colitisInfections and infestations
DiverticulitisInfections and infestations
EndocarditisInfections and infestations
PeritonitisInfections and infestations
PharyngitisInfections and infestations
Pneumonia streptococcalInfections and infestations
Other adverse events (16 terms — click to expand)

ReactionSystemAIN457 300 mgUST 45/90 mgAll Patients
Upper respiratory tract infectionInfections and infestations
NasopharyngitisInfections and infestations
HeadacheNervous system disorders
DiarrhoeaGastrointestinal disorders
SinusitisInfections and infestations
HypertensionVascular disorders
Back painMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
PruritusSkin and subcutaneous tissue disorders
BronchitisInfections and infestations
ArthralgiaMusculoskeletal and connective tissue disorders
Urinary tract infectionInfections and infestations
Dermatitis contactSkin and subcutaneous tissue disorders
NauseaGastrointestinal disorders
ConjunctivitisInfections and infestations

Most-reported serious reactions: Atrial fibrillation, Cellulitis, Acute respiratory failure, Deep vein thrombosis, Ventricular tachycardia, Dengue fever, Lymphadenopathy, Angina pectoris.

Data from ClinicalTrials.gov NCT02826603 adverse events section.

Sponsor's own description

Demonstrate superiority of secukinumab over ustekinumab 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. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results).
    Bagel J, Nia J, Hashim PW, Patekar M, et al · · 2018 · cited 62× · PMID 30334147 · DOI 10.1007/s13555-018-0265-y
  6. 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
  7. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
    Merola JF, McInnes IB, Deodhar AA, Dey AK, et al · · 2022 · cited 30× · PMID 35305260 · DOI 10.1007/s40744-022-00434-z
  8. Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY).
    Bagel J, Blauvelt A, Nia J, Hashim P, et al · · 2021 · cited 30× · PMID 32365251 · DOI 10.1111/jdv.16558

Verify or expand the search:

Other trials of Secukinumab

Trials testing the same drug.

Other recruiting trials for Plaque Psoriasis

Currently open trials in the same condition.

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

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