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Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03668613
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis. Approximately 80 subjects (at least 60 subjects with moderate severity) will be enrolled. subjects will be stratified by weight. It is expected that subjects will be enrolled in about 40 centers worldwide.

Condition or disease Intervention/treatment Phase
Moderate to Severe Chronic Plaque-type Psoriasis Drug: secukinumab low dose Drug: secukinumab high dose Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter Trial to Assess the Efficacy of Subcutaneous Secukinumab after12 Weeks of Treatment, and to Assess the Long-term Safety, Tolerability, Efficacy in Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
Actual Study Start Date : August 29, 2018
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: secukinumab low dose
secukinumab low dose
Drug: secukinumab low dose
dose depends on the weight group

Experimental: secukinumab high dose
secukinumab high dose
Drug: secukinumab high dose
dose depends on the weight group




Primary Outcome Measures :
  1. Number of participants with PASI 75 response [ Time Frame: week 12 ]

    Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per the standard procedure

    PASI 75 represents the percentage (or number) of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.


  2. Number of participants with IGA mod 2011 0 or 1 response [ Time Frame: week 12 ]
    Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease)


Secondary Outcome Measures :
  1. Number of particiopants with PASI 90 response [ Time Frame: week 12 ]

    Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per the standard procedure

    PASI 90 represents the percentage (or number) of patients who have achieved a 90% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.

    *Other clinical laboratory variables may be included in the results reporting


  2. Number of Participants with Adverse Events [ Time Frame: up to week 224 ]
    clinical safety and tolerability will be assessed by adverse event monitoring

  3. Secukinumab concentration in serum [ Time Frame: up to week 224 ]
    standard pharmacokinetic parameters will be evaluated



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.
  2. Must be 6 to less than 18 years of age at the time of randomization
  3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization.
  4. Subject being regarded by the investigator to be a candidate for systemic therapy.

Exclusion Criteria:

  1. Forms of psoriasis other than chronic plaque-type active at randomization
  2. Drug-induced psoriasis
  3. Ongoing use of prohibited treatments
  4. Female subjects of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 16 weeks after stopping study treatment
  5. Pregnant or nursing (lactating) females
  6. Subjects with total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL at screening
  7. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor

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): NCT03668613


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

Locations
United States, California
Novartis Investigative Site Recruiting
California City, California, United States, 92708
United States, Florida
Novartis Investigative Site Recruiting
Jacksonville, Florida, United States, 32256
United States, Texas
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78218
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
Estonia
Novartis Investigative Site Recruiting
Tartu, Estonia, 51014
Poland
Novartis Investigative Site Recruiting
Warszawa, Mazowian, Poland, 02 495
Novartis Investigative Site Recruiting
Rzeszow, Poland, 35-055
Russian Federation
Novartis Investigative Site Recruiting
Kazan, Russian Federation, 420012
Novartis Investigative Site Recruiting
Krasnodar, Russian Federation, 350020
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 119296
Novartis Investigative Site Recruiting
Saint Petersburg, Russian Federation, 191123
Spain
Novartis Investigative Site Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site Recruiting
Madrid, Spain, 28041
Novartis Investigative Site Recruiting
Madrid, Spain, 28046
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03668613     History of Changes
Other Study ID Numbers: CAIN457A2311
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 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


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
pediatric
secukinumab
plaque psoriasis
AIN457A

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