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Trial record 1 of 1 for:    CAIN457A2324
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Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More wt Group With Moderate/Severe Chronic Plaque Psoriasis (AIN457A2324)

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. Identifier: NCT03504852
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : July 27, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Demonstrate superiority of secukinumab high dose over standard dose in heavy body weight subjects with moderate to severe plaque psoriasis.

Condition or disease Intervention/treatment Phase
Moderate to Severe Chronic Plaque-type Psoriasis Drug: secukinumab 150 mg Phase 3

Detailed Description:

A 52-week multicenter, randomized, double-blind, parallel-group trial in approximately 330 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization.

The study consists of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks), treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).

Subjects will be randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg every 2 weeks; Secukinumab 300 mg every 4 weeks.

In addition, subjects from the 300 mg every 4 weeks group who do not achieve PASI 90 response at Week 16 will be randomized using a 1:1 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Multicenter Study Assessing Short and Long-term Efficacy, Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : September 13, 2019
Estimated Study Completion Date : July 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab 300 mg every 2 weeks
2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects will remain on secukinumab 300 mg every 2 weeks until the end of treatment
Drug: secukinumab 150 mg
sub-cutaneous secukinumab prefilled syringe 150 mg

Active Comparator: Secukinumab 300 mg every 4 weeks
2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 4 weeks. Starting at Week 6, 2 secukinumab placebo (dummy drug) injections will be alternated every 4 weeks to maintain the blind. Subjects in this arm who do not achieve PASI 90 response at Week 16 will be randomized at Baseline to either remain on secukinumab 300 mg every 4 weeks or to receive secukinumab 300 mg every 2 weeks starting at Week 16 until the end of the treatment period
Drug: secukinumab 150 mg
sub-cutaneous secukinumab prefilled syringe 150 mg

Primary Outcome Measures :
  1. PASI 90 Response [ Time Frame: 16 weeks ]
    Percentage of subjects who achieve 90% or greater reduction in PASI score compared to baseline

Secondary Outcome Measures :
  1. IGA mod 2011 0 or 1 response [ Time Frame: 16 weeks ]
    Percentage of subjects who achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale 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

Key Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
  2. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study.
  3. Men or women at least 18 years of age at time of screening.
  4. Body weight of ≥ 90 kg at the time of randomization.
  5. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
  6. Moderate to severe psoriasis as defined at randomization by:

    • Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
    • IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
    • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
  7. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:

    • topical treatment and/or,
    • phototherapy and/or,
    • previous systemic therapy.

Key Exclusion Criteria:

  1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.
  2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
  3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin-17 (IL-17) or the IL-17 receptor.
  4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
  5. Pregnant or nursing (lactating) women
  6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
  7. History of hypersensitivity to any of the study drug constituents.

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 identifier (NCT number): NCT03504852

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United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35205
United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85032
United States, Arkansas
Novartis Investigative Site
Rogers, Arkansas, United States, 72758
United States, California
Novartis Investigative Site
Irvine, California, United States, 92697
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Sacramento, California, United States, 95817
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Sacramento, California, United States, 95819
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San Diego, California, United States, 92123
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Santa Monica, California, United States, 90404
United States, Colorado
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Centennial, Colorado, United States, 80111
United States, Florida
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Tampa, Florida, United States, 33612
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West Palm Beach, Florida, United States, 33409
United States, Georgia
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Alpharetta, Georgia, United States, 30022
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Snellville, Georgia, United States, 30078
United States, Illinois
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Skokie, Illinois, United States, 60077
United States, Indiana
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Indianapolis, Indiana, United States, 46256
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New Albany, Indiana, United States, 47150
United States, Kentucky
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Louisville, Kentucky, United States, 40241
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Owensboro, Kentucky, United States, 42303
United States, Massachusetts
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Boston, Massachusetts, United States, 02111
United States, Minnesota
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New Brighton, Minnesota, United States, 55112
United States, Missouri
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Saint Joseph, Missouri, United States, 64506
United States, New Jersey
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East Windsor, New Jersey, United States, 08520
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Verona, New Jersey, United States, 07044
United States, New York
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Forest Hills, New York, United States, 11375
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New York, New York, United States, 10025 1737
United States, North Carolina
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Charlotte, North Carolina, United States, 28277
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Winston-Salem, North Carolina, United States, 27157
United States, Ohio
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Fairborn, Ohio, United States, 45324
United States, Oregon
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Oregon City, Oregon, United States, 97045
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Portland, Oregon, United States, 97210
United States, South Carolina
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Charleston, South Carolina, United States, 29414
United States, Texas
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Austin, Texas, United States, 78746
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Houston, Texas, United States, 77056
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Mesquite, Texas, United States, 75150
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Pflugerville, Texas, United States, 78660
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San Antonio, Texas, United States, 78218
United States, Virginia
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Norfolk, Virginia, United States, 23507
United States, Washington
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Wenatchee, Washington, United States, 98801
United States, Wisconsin
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Madison, Wisconsin, United States, 53717
Canada, Alberta
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Calgary, Alberta, Canada, T2G 1B1
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Red Deer, Alberta, Canada, T4N 6V7
Canada, Ontario
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Etobicoke, Ontario, Canada, M8X 1Y9
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Guelph, Ontario, Canada, N1L 0B7
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Hamilton, Ontario, Canada, L8N 1V6
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Quebec, Canada, G1V 4X7
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Prague, Prague 1, Czechia, 11000
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Novy Jicin, Czechia, 741 01
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Bochum, Germany, 44793
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Frankfurt, Germany, 60590
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Hamburg, Germany, 20246
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Hamburg, Germany, 20537
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Kiel, Germany, 24105
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Leipzig, Germany, 04103
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Debrecen, Hungary, 4032
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Pecs, Hungary, 7632
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Szeged, Hungary, H 6725
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Rozzano, MI, Italy, 20089
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Modena, MO, Italy, 41124
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Perugia, PG, Italy, 06100
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Siena, SI, Italy, 53100
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Napoli, Italy, 80138
Russian Federation
Novartis Investigative Site
Chelyabinsk, Russian Federation, 454092
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Ekaterinburg, Russian Federation, 620023
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Kazan, Russian Federation, 420012
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Krasnodar, Russian Federation, 350020
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Lipetsk, Russian Federation, 398005
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Saint Petersburg, Russian Federation, 197022
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Saratov, Russian Federation, 410012
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT03504852    
Other Study ID Numbers: CAIN457A2324
2015-004620-60 ( EudraCT Number )
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
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

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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 ):
immune-mediated systemic disease
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases