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Trial record 1 of 1 for:    cain457a2326
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Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis (CLARITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02826603
Recruitment Status : Completed
First Posted : July 11, 2016
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1114 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. Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 [ Time Frame: 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) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).


  2. Participants With IGA Mod 2011 0 or 1 at Week 12 [ Time Frame: 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)


Secondary Outcome Measures :
  1. Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 [ Time Frame: Week 12 ]
    Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.

  2. Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 [ Time Frame: Week 4 ]
    Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.

  3. Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 [ Time Frame: Week 16 ]
    Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.

  4. Participants With IGA Mod 2011 0 or 1 at 16 Weeks [ Time Frame: 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)

  5. Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12 [ Time Frame: Week 12 ]
    Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.

  6. Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 [ Time Frame: Week 16 ]
    Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.

  7. Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 [ Time Frame: Week 16 ]
    Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.

  8. Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52 [ Time Frame: Week 52 ]
    Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
Show Show 155 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] April 22, 2016
Statistical Analysis Plan  [PDF] July 18, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02826603    
Other Study ID Numbers: CAIN457A2326
2015-002898-37 ( EudraCT Number )
First Posted: July 11, 2016    Key Record Dates
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019
Last Verified: June 2019
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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Plaque psoriasis
secukinumab
ustekinumab
ain457
ain457a
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents