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Efficacy and Safety of 2 Secukinumab Regimens in 90 kg or Higher Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

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ClinicalTrials.gov Identifier: NCT03504852
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : June 14, 2019
Sponsor:
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)
Estimated Enrollment : 330 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 (16 Weeks) and Long-term Efficacy (up to 1 Year), 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 : January 8, 2018
Estimated Primary Completion Date : February 24, 2020
Estimated Study Completion Date : August 21, 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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT03504852


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

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Locations
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United States, Alabama
Novartis Investigative Site Active, not recruiting
Birmingham, Alabama, United States, 35205
United States, Arizona
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85032
United States, Arkansas
Novartis Investigative Site Active, not recruiting
Rogers, Arkansas, United States, 72758
United States, California
Novartis Investigative Site Active, not recruiting
Irvine, California, United States, 92697
Novartis Investigative Site Recruiting
Sacramento, California, United States, 95817
Novartis Investigative Site Recruiting
Sacramento, California, United States, 95819
Novartis Investigative Site Active, not recruiting
San Diego, California, United States, 92123
Novartis Investigative Site Active, not recruiting
Santa Monica, California, United States, 90404
United States, Colorado
Novartis Investigative Site Recruiting
Centennial, Colorado, United States, 80111
United States, Florida
Novartis Investigative Site Recruiting
Ormond Beach, Florida, United States, 32174
Novartis Investigative Site Active, not recruiting
Tampa, Florida, United States, 33612
Novartis Investigative Site Active, not recruiting
West Palm Beach, Florida, United States, 33409
United States, Georgia
Novartis Investigative Site Recruiting
Alpharetta, Georgia, United States, 30022
Novartis Investigative Site Active, not recruiting
Snellville, Georgia, United States, 30078
United States, Illinois
Novartis Investigative Site Active, not recruiting
Skokie, Illinois, United States, 60077
United States, Indiana
Novartis Investigative Site Active, not recruiting
Indianapolis, Indiana, United States, 46256
Novartis Investigative Site Recruiting
New Albany, Indiana, United States, 47150
United States, Kentucky
Novartis Investigative Site Active, not recruiting
Louisville, Kentucky, United States, 40241
Novartis Investigative Site Active, not recruiting
Owensboro, Kentucky, United States, 42303
United States, Massachusetts
Novartis Investigative Site Active, not recruiting
Boston, Massachusetts, United States, 02111
United States, Minnesota
Novartis Investigative Site Recruiting
Fridley, Minnesota, United States, 55432
United States, Missouri
Novartis Investigative Site Recruiting
Saint Joseph, Missouri, United States, 64506
United States, New Jersey
Novartis Investigative Site Active, not recruiting
East Windsor, New Jersey, United States, 08520
Novartis Investigative Site Recruiting
Verona, New Jersey, United States, 07044
United States, New York
Novartis Investigative Site Recruiting
Forest Hills, New York, United States, 11375
Novartis Investigative Site Recruiting
New York, New York, United States, 10025 1737
United States, North Carolina
Novartis Investigative Site Active, not recruiting
Charlotte, North Carolina, United States, 28277
Novartis Investigative Site Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Novartis Investigative Site Recruiting
Fairborn, Ohio, United States, 45324
United States, Oregon
Novartis Investigative Site Recruiting
Oregon City, Oregon, United States, 97045
Novartis Investigative Site Recruiting
Portland, Oregon, United States, 97210
United States, South Carolina
Novartis Investigative Site Recruiting
Charleston, South Carolina, United States, 29414
United States, Texas
Novartis Investigative Site Completed
Austin, Texas, United States, 78746
Novartis Investigative Site Active, not recruiting
Houston, Texas, United States, 77056
Novartis Investigative Site Recruiting
Mesquite, Texas, United States, 75150
Novartis Investigative Site Active, not recruiting
Pflugerville, Texas, United States, 78660
Novartis Investigative Site Active, not recruiting
San Antonio, Texas, United States, 78218
United States, Virginia
Novartis Investigative Site Active, not recruiting
Norfolk, Virginia, United States, 23507
United States, Washington
Novartis Investigative Site Recruiting
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Novartis Investigative Site Active, not recruiting
Madison, Wisconsin, United States, 53717
Canada, Alberta
Novartis Investigative Site Active, not recruiting
Calgary, Alberta, Canada, T2G 1B1
Novartis Investigative Site Active, not recruiting
Red Deer, Alberta, Canada, T4N 6V7
Canada, Ontario
Novartis Investigative Site Active, not recruiting
Etobicoke, Ontario, Canada, M8X 1Y9
Novartis Investigative Site Active, not recruiting
Guelph, Ontario, Canada, N1L 0B7
Novartis Investigative Site Active, not recruiting
Hamilton, Ontario, Canada, L8N 1V6
Canada
Novartis Investigative Site Active, not recruiting
Quebec, Canada, G1V 4X7
Czechia
Novartis Investigative Site Active, not recruiting
Prague, Prague 1, Czechia, 11000
Novartis Investigative Site Active, not recruiting
Novy Jicin, Czechia, 741 01
Germany
Novartis Investigative Site Recruiting
Bochum, Germany, 44793
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Recruiting
Hamburg, Germany, 20537
Novartis Investigative Site Recruiting
Kiel, Germany, 24105
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Hungary
Novartis Investigative Site Recruiting
Debrecen, Hungary, 4032
Novartis Investigative Site Recruiting
Pecs, Hungary, 7632
Novartis Investigative Site Recruiting
Szeged, Hungary, H-6725
Italy
Novartis Investigative Site Active, not recruiting
Rozzano, MI, Italy, 20089
Novartis Investigative Site Active, not recruiting
Modena, MO, Italy, 41124
Novartis Investigative Site Active, not recruiting
Perugia, PG, Italy, 06100
Novartis Investigative Site Active, not recruiting
Siena, SI, Italy, 53100
Novartis Investigative Site Active, not recruiting
Napoli, Italy, 80138
Russian Federation
Novartis Investigative Site Recruiting
Chelyabinsk, Russian Federation, 454092
Novartis Investigative Site Recruiting
Ekaterinburg, Russian Federation, 620023
Novartis Investigative Site Active, not recruiting
Kazan, Russian Federation, 420012
Novartis Investigative Site Recruiting
Krasnodar, Russian Federation, 350020
Novartis Investigative Site Active, not recruiting
Lipetsk, Russian Federation, 398005
Novartis Investigative Site Active, not recruiting
Saint Petersburg, Russian Federation, 197022
Novartis Investigative Site Active, not recruiting
Saratov, Russian Federation, 410012
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03504852     History of Changes
Other Study ID Numbers: CAIN457A2324
2015-004620-60 ( EudraCT Number )
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: June 14, 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 ):
psoriasis
secukinumab
immune-mediated systemic disease
papules
plaques
itching

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