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Monoclonal Antibodies

Experimental: Secukinumab high dose for Plaque Psoriasis

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Plaque-type psoriasis history for at least 3 months

Patient being regarded by the investigator to be a candidate for systemic therapy because of: inadequate control of symptoms with topical treatment, or failure to respond to or tolerate previous systemic treatment and/or UV therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 16, 20, 24, 36, 48 and 52

Awards & highlights

Study Summary

This trial was a study of a new medication for plaque psoriasis in children aged 6-18 years old. The study compared the new medication to a placebo and an active control (a different medication).

Eligible Conditions

Chronic Severe Plaque Psoriasis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have had plaque-type psoriasis for at least 3 months.

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You have not found relief from your symptoms with topical treatments or have had difficulty tolerating previous treatments, and your doctor thinks you may need systemic therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 16, 20, 24, 36, 48 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 16, 20, 24, 36, 48 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 16, 20, 24, 36, 48 and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number and Percentage of Participants Achieving a 75% Improvement From Baseline in PASI Score at Week 12

Number and Percentage of Participants Who Showed Investigator's Global Assessment (IGA) Mod 2011 Response of 0 or 1 at Week 12

Secondary outcome measures

Change From Baseline in Psoriasis Area & Severity Index (PASI) Score at Week 12

Change From Baseline in Psoriasis Area & Severity Index (PASI) Scores at Week 52

Number and Percentage of Participants Achieving a 50%, 100% Improvement From Baseline in PASI Score at Week 12

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Secukinumab low doseExperimental Treatment1 Intervention

Secukinumab

Group II: Secukinumab high doseExperimental Treatment1 Intervention

Secukinumab

Group III: Etanercept ComparatorActive Control1 Intervention

Etanercept

Group IV: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Experimental: Secukinumab high dose

2015

Completed Phase 3

~170

Experimental : Secukinumab low dose

2015

Completed Phase 3

~170

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,188 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most similar studies to : Secukinumab low dose that have already been completed?

"As of right now, there are 59 ongoing studies for Experimental : Secukinumab low dose and 21 of them are in Phase 3. The global locations conducting research trials number 1647 with the majority being in Xi'an, Shaanxi."

Answered by AI

Are patients over the age of 55 welcome in this trial?

"The age range for this particular clinical trial is 6 to 17. Out of the 41 trials taking place with patients under 18, this is one of them. In contrast, there are 202 trials involving people over 65 years old."

Answered by AI

Do patients who take Secukinumab low dose experience many side effects?

"There is clinical data to support the efficacy of secukinumab, making it a 3 on our 1-3 scale."

Answered by AI

Why is secukinumab prescribed in small doses?

"The low dose of secukinumab is a novel treatment for psoriatic arthritis that has also shown efficacy in other conditions like polyarticular juvenile idiopathic arthritis, severe plaque psoriasis, and objective signs of inflammation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis

2015. "Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02471144.