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Completed

NCT Number: NCT02826603

Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

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

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, St. John's, Newfoundland and Labrador, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

secukinumab

Drug

300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48

Ustekinumab

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

Acronym: CLARITY

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2016
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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