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Secukinumab for Plaque Psoriasis (STEPin Trial)
STEPin Trial Summary
This trial is testing whether a new medication can prevent plaque psoriasis from getting worse or spreading.
- Plaque Psoriasis
STEPin Trial Timeline
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 • NCT03055494STEPin Trial Design
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Who is running the clinical trial?
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- Your psoriasis is not the common type called plaque psoriasis.You recently developed psoriasis within the past year and have not received any medications or light therapy for it yet.You have received treatment in the past using light therapy or any medications taken throughout your entire body.You are currently taking medications or treatments that are not allowed in this study.You have had chronic plaque psoriasis for at least 5 years and have tried different treatments, including light therapy and medications, but they haven't worked well for you. However, if you have tried IL-17A inhibitors, you can still participate.
- Group 1: Arm C1: chronic plaque psoriasis to be treated with secukinumab
- Group 2: Arm A1 (A1a and A1b): new-onset plaque psoriasis to be treated with secukinumab
- Group 3: Arm A2: new-onset plaque psoriasis to be treated with secukinumab
- Group 4: Arm C2: chronic plaque psoriasis to be treated with secukinumab
- Group 5: Arm B1 (B1a and B1b): new-onset plaque psoriasis to be treated with nb-UVB
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Is this experiment an unprecedented exploration of its type?
"Presently, 45 live trials for Secukinumab are occurring in 347 cities and 54 countries. The original study was funded by Mantecorp Industria Quimica e Farmaceutica Ltd., featuring 170 patients, which completed its Phase 3 approval back in 2010. Since then, 273 additional investigations have been finalized successfully."
Is my participation an option in this trial?
"This trial is enrolling 196 individuals aged between 18 and 50 with psoriasis. Qualifying patients must have the capacity to comprehend and interact with researchers, adhere to all procedures of the study, present a valid informed consent document (either in person or through witness), suffer from either new-onset plaque psoriasis (within 12 months) without systemic treatment/phototherapy OR chronic plaque psoriasis that has been active for five years or more but is resistant to any form of therapy including biologicals (except IL-17A inhibitors). Other criteria include a PASI score ≥ 10%, BSA≥10% and I"
Has the FDA sanctioned Secukinumab for public use?
"There is significant backing for the safety of secukinumab, so it was rated a 3 due to its phase 4 trial status which implies approval."
Are there any preceding experiments involving Secukinumab?
"Currently, there are 45 active studies concerning Secukinumab with 18 of them being in the last phase. Although many locations for these clinical trials reside in Afula and Cluj, a total of 1107 medical sites have operations running on this drug."
What is the upper limit of participants involved in this research project?
"Affirmative. Data hosted on clinicaltrials.gov attests that this experiential research, which was initially advertised on March 27th 2017, is actively seeking enrolment. Approximately 196 volunteers need to be recruited from 1 different medical centre."
Does this program include people aged 55 and over?
"To be eligible for this trial, applicants must fall between the ages of 18 and 50. Alternatively, 40 trials are available to minors while 177 studies cater to elderly populations."
Are there any vacancies available for individuals to participate in this clinical trial?
"This medical experiment is actively recruiting participants, as evidenced by the clinicaltrials.gov listing that was first posted on March 27th 2017 and last amended on July 20th 2022."
What indications does Secukinumab generally address?
"Secukinumab is often prescribed to those suffering from nephrotic syndrome, yet it can also be utilised for the treatment of a variety of other conditions such as brain tumours, ophthalmia, sympathetic disorders and eye diseases."
Who else is applying?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
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