ClinicalTrials.Veeva

Menu

Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis (CLARITY)

Novartis logo

Novartis

Status and phase

Completed
Phase 3

Conditions

Plaque Psoriasis

Treatments

Drug: Ustekinumab
Drug: Secukinumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02826603
2015-002898-37 (EudraCT Number)
CAIN457A2326

Details and patient eligibility

About

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

Enrollment

1,114 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must give a written, signed and dated informed consent

  • Chronic plaque-type psoriasis present for at least 6 months before randomization

  • Moderate to severe plaque psoriasis as defined at randomization by:

    • PASI score of ≥12 and
    • Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
    • IGA mod 2011 ≥3 (based on a scale of 0-4)
  • Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:

    • Topical treatment (including topical corticosteroids) and/or
    • Phototherapy and/or
    • Previous systemic therapy

Exclusion criteria

  • Forms of psoriasis other than plaque psoriasis
  • Drug-induced psoriasis
  • Ongoing use of prohibited treatments
  • Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
  • Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,114 participants in 2 patient groups

Secukinumab
Experimental group
Description:
Secukinumab
Treatment:
Drug: Secukinumab
Ustekinumab
Active Comparator group
Description:
Ustekinumab
Treatment:
Drug: Ustekinumab

Trial documents
2

Trial contacts and locations

155

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems