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Trial record 30 of 762 for:    plaque | "Psoriasis"

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

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ClinicalTrials.gov Identifier: NCT02826603
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Secukinumab Drug: Ustekinumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : June 22, 2016
Actual Primary Completion Date : July 9, 2018
Actual Study Completion Date : July 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Secukinumab
Secukinumab
Drug: Secukinumab
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48

Active Comparator: Ustekinumab
Ustekinumab
Drug: Ustekinumab
Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.




Primary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) 90 [ Time Frame: Week 12 ]
    Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per usual standard.

  2. Investigator's Global Assessment (IGA) mod 2011 0/1 [ Time Frame: Week 12 ]
    Investigator will assess disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease)


Secondary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline to Week 52 ]
    Psoriasis Area and Severity Index (PASI) will be assessed.

  2. Investigator's Global Assessment (IGA) mod 2011 0/1 [ Time Frame: Baseline to Week 52 ]
    Investigator will assess disease using a validated scale (IGA mod 2011)

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Week 52 ]
    Clinical safety and tolerability will be assessed up to Week 52 by adverse events monitoring.

  4. Changes in clinical laboratory variables [Safety and Tolerability] [ Time Frame: Week 52 ]
    Clinical safety will be assessed up to Week 52 by changes in clinical laboratory variables



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826603


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Sponsors and Collaborators
Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02826603     History of Changes
Other Study ID Numbers: CAIN457A2326
2015-002898-37 ( EudraCT Number )
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Plaque psoriasis,
secukinumab,
ustekinumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Ustekinumab
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents