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Monoclonal Antibodies

secukinumab high dose for Chronic Plaque-type 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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baleine, weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208
Awards & highlights

Study Summary

This trial was testing a new medication for plaque psoriasis in children aged 6 to 18. 84 subjects were enrolled and most had moderate severity.

Eligible Conditions
  • Moderate to Severe Chronic Plaque-type Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baleine, weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208
This trial's timeline: 3 weeks for screening, Varies for treatment, and baleine, weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208 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 With IGA Mod 2011 0 or 1 Response
Number and Percentage of Participants With PASI 75 Response
Secondary outcome measures
Number and Percentage of Participants With PASI 90 Response
Secukinumab Concentration in Serum
Summary Table of Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Group I: secukinumab low doseExperimental Treatment1 Intervention
secukinumab low dose
Group II: secukinumab high doseExperimental Treatment1 Intervention
secukinumab high dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
FDA approved
Secukinumab
FDA approved

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,266 Total Patients Enrolled

Media Library

Secukinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03668613 — Phase 3
Chronic Plaque-type Psoriasis Research Study Groups: secukinumab high dose, secukinumab low dose
Chronic Plaque-type Psoriasis Clinical Trial 2023: Secukinumab Highlights & Side Effects. Trial Name: NCT03668613 — Phase 3
Secukinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03668613 — Phase 3

Frequently Asked Questions

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

Are people currently being recruited for this experiment?

"This clinical trial is no longer admitting patients. The study began on 8/29/2018 and was last updated on 7/22/2021. However, there are presently 179 other trials enrolling psoriasis patients and 28 secukinumab high dose trials recruiting participants."

Answered by AI

Has the FDA given its blessing to high doses of secukinumab?

"There is some data supporting the efficacy of secukinumab high dose, and it has undergone multiple rounds of testing for safety, so our team at Power gave it a score of 3."

Answered by AI

Are the findings from this study unique or have other researchers looked at high doses of secukinumab?

"secukinumab high dose was first investigated in 2014 at Attikon Hospital. So far, there have been 110 completed studies with 28 more currently underway. A large portion of these active clinical trials are based out of San Antonio, Texas."

Answered by AI

What are the conditions that high doses of secukinumab have been known to effectively manage?

"Secukinumab high dose is frequently used in the treatment of ankylosing spondylitis. However, it has also been shown to mitigate symptoms of psoriatic arthritis, enthesitis related arthritis (era), and severe plaque psoriasis."

Answered by AI

How many people are being enrolled in this clinical trial?

"This study is not admitting patients at the moment. The most recent update on this trial was on July 22nd, 2021 and it was initially posted on August 29th, 2018. If you are looking for other trials, there are presently 179 clinical trials actively admitting patients with psoriasis and 28 trials for secukinumab high dose actively looking for patients."

Answered by AI

Is this a widespread trial or are the sites limited to a specific region?

"There are 4 primary sites conducting this clinical trial, however other locations include San Antonio, Lebanon and Fountain Valley. To reduce the amount of travelling required, patients are encouraged to select the location nearest them."

Answered by AI

Does this experiment only use test subjects that are 55 years or older?

"This particular clinical trial is only open to people aged 6-17, which falls in line with the 37 other trials for minors and the 175 trials for adults over 65."

Answered by AI

Are there any exclusionary factors for this research?

"Children aged 6 to 17 that have psoriasis can participate in this clinical trial. A total of 84 patients are needed for the study."

Answered by AI
Recent research and studies
Journal of the American Academy of DermatologyJournal
A Phase 3 Open-label, Randomized Multicenter Study to Evaluate Efficacy and Safety of Secukinumab in Pediatric Patients with Moderate to Severe Plaque Psoriasis: 24-week Results
Magnolo, Nina, Külli Kingo, Vivian Laquer, John Browning, Adam Reich, Jacek C. Szepietowski, Deborah Keefe, et al.. 2022. “A Phase 3 Open-label, Randomized Multicenter Study to Evaluate Efficacy and Safety of Secukinumab in Pediatric Patients with Moderate to Severe Plaque Psoriasis: 24-week Results”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2021.08.066.
Journal of the American Academy of DermatologyJournal
A Phase 3 Open-label, Randomized Multicenter Study to Evaluate Efficacy and Safety of Secukinumab in Pediatric Patients with Moderate to Severe Plaque Psoriasis: 24-week Results
Magnolo, Nina, Külli Kingo, Vivian Laquer, John Browning, Adam Reich, Jacek C. Szepietowski, Deborah Keefe, et al.. 2022. “A Phase 3 Open-label, Randomized Multicenter Study to Evaluate Efficacy and Safety of Secukinumab in Pediatric Patients with Moderate to Severe Plaque Psoriasis: 24-week Results”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2021.08.066.
Journal of the American Academy of DermatologyJournal
A Phase 3 Open-label, Randomized Multicenter Study to Evaluate Efficacy and Safety of Secukinumab in Pediatric Patients with Moderate to Severe Plaque Psoriasis: 24-week Results
Magnolo, Nina, Külli Kingo, Vivian Laquer, John Browning, Adam Reich, Jacek C. Szepietowski, Deborah Keefe, et al.. 2022. “A Phase 3 Open-label, Randomized Multicenter Study to Evaluate Efficacy and Safety of Secukinumab in Pediatric Patients with Moderate to Severe Plaque Psoriasis: 24-week Results”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2021.08.066.
Pediatric DrugsJournal
Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study
Magnolo, Nina, Külli Kingo, Vivian Laquer, John Browning, Adam Reich, Jacek C. Szepietowski, Deborah Keefe, et al.. 2022. “Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study”. Pediatric Drugs. Springer Science and Business Media LLC. doi:10.1007/s40272-022-00507-0.
~13 spots leftby Apr 2025
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