Expired Study
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Miami, Florida 33155


Purpose:

This was 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. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified by weight.


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


Study is Available At:


Original ID:

CAIN457A2311


NCT ID:

NCT03668613


Secondary ID:

2017-004515-39


Study Acronym:


Brief Title:

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


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

6 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

84


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:August 29, 2018
Completion Date:September 13, 2023
Completion Type:Anticipated
Primary Completion Date:September 18, 2019
Primary Completion Type:Anticipated
Verification Date:July 2019
Last Changed Date:July 11, 2019
First Received Date:August 23, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Secukinumab concentration in serum
Time Frame:up to week 224
Safety Issues:False
Description:standard pharmacokinetic parameters will be evaluated
Outcome Type:Secondary Outcome
Measure:Number of Participants with Adverse Events
Time Frame:up to week 224
Safety Issues:False
Description:clinical safety and tolerability will be assessed by adverse event monitoring
Outcome Type:Secondary Outcome
Measure:Number of particiopants with PASI 90 response
Time Frame:week 12
Safety Issues:False
Description: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 p
Outcome Type:Primary Outcome
Measure:Number of participants with IGA mod 2011 0 or 1 response
Time Frame:week 12
Safety Issues:False
Description: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)
Outcome Type:Primary Outcome
Measure:Number of participants with PASI 75 response
Time Frame:week 12
Safety Issues:False
Description: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 p

Study Interventions

Intervention Type:Drug
Name:secukinumab low dose
Description:dose depends on the weight group
Arm Name:secukinumab low dose
Intervention Type:Drug
Name:secukinumab high dose
Description:dose depends on the weight group
Arm Name:secukinumab high dose

Study Arms

Study Arm Type:Experimental
Arm Name:secukinumab low dose
Description:secukinumab low dose
Study Arm Type:Experimental
Arm Name:secukinumab high dose
Description:secukinumab high dose

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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