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Secukinumab for Psoriasis
Study Summary
This trial will test whether a biologic drug can improve brain plasticity and perception of well-being for people with psoriasis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 4 trial • 102 Patients • NCT03055494Trial Design
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- I haven't started or changed doses of medications for mood, psychosis, or nerve pain in the last 3 months.I am currently diagnosed with an active major psychiatric disorder.I weigh 250 pounds or more.I don't have a pacemaker, stents, metal implants, or braces that would interfere with an MRI.I have had a TB test within the last 8 months or need one provided.My psoriasis affects more than 5% of my body.I am extremely overweight.I will take a pregnancy test to confirm I'm not pregnant.I am generally healthy with no history of major neurological, psychiatric, chronic pain, or skin conditions.You are allergic to biologic medications.I haven't used biologics in the last 8 weeks or Otezla in the last 4 weeks.I only use medication affecting the brain as needed.I am between 18 and 65 years old.My psoriasis affects more than 5% of my body.You are of child bearing potential.I use antihistamines for itch relief.I do not have any diseases that could interfere with the study or increase infection risk.I am generally healthy with no history of major neurological, psychiatric, or chronic conditions.I am between 18 and 65 years old.I cannot complete the required health assessments.I have been treated with IL-17 targeting drugs before.I have a chronic infectious disease or inflammatory bowel disease.My thyroid condition is not under control.I am between 18 and 65 years old.I have an immune condition affecting IL-17.Currently in prison.You have used illegal drugs or have been addicted to opiates in the past.I am currently taking opioid painkillers.I am on biologic treatment and have not received any live vaccines.You haven't had a tuberculosis test that came back negative in the last 12 months.
- Group 1: Psoriasis Group
- Group 2: Healthy Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the research team accept younger individuals for this trial?
"This experiment necessitates that participants are aged between 18-65. Simultaneously, there are 86 trials available for minors and 537 clinical studies applicable to the elderly population."
Has Secukinumab gone through the necessary regulatory processes to be deemed safe for public consumption?
"Per our assessment, secukinumab is assessed to have a high degree of safety due it its Phase 4 trial status and concomitant approval for medical use."
Is there an opportunity for participants to join this research currently?
"Affirmative. Clinicaltrials.gov suggest that this examination is actively enrolling participants as of now, with the trial having been first posted on June 29th 2021 and most recently updated around September 2022. To meet their goals, they need to recruit 40 patients from 1 medical centre."
What are the fundamental aims of this trial?
"This clinical trial seeks to assess the alteration of gray matter density within a Baseline, Up to Week 4 (Visit 3) timeline. Secondary objectives include evaluation of itch intensity using NRS ratings ranging from 0-10, sleep quality measured via PSQI scores between 0 and 49, as well as pain levels appraised with an identical numerical rating system."
Would I be eligible to partake in this clinical research?
"This clinical trial is enrolling 40 qualified participants aged 18 to 65 years old, who suffer from psoriasis. To be eligible for the study they must meet the following prerequisites: no contraindications to MRI scanning as verified by an MRI technologist using a site-approved screening form; a body surface area (BSA) of more than 5% affected by psoriasis and evidence of TB test in past 8 months or willingness to undertake one; absence of chronic pain, itch, skin conditions and any neurological/psychiatric diseases; women with child bearing potential will require pregnancy testing prior to enrolment; English fluency both"
Are there any analogous experiments involving Secukinumab?
"Currently, 27 clinical trials are being conducted to evaluate the efficacy of secukinumab. Among them, 13 have advanced into Phase 3. The primary sites for such research are Brest and Buenos Aires; however, over a thousand locations around the world are offering this therapy as part of their own experiments."
What circumstances is Secukinumab typically prescribed for?
"Secukinumab has been clinically tested to treat ankylosing spondylitis, psoriatic arthritis, and enthesitis related arthritis (ERA)."
What is the total enrollment of this experiment?
"Indeed, the data available on clinicaltrials.gov indicates that this medical trial is in a current search of participants. The first posting occurred on June 29th 2021 and has had its most recent update September 29th 2022. 40 patients need to be found over one site for recruitment purposes."
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