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Risankizumab Injection for Psoriasis (OptIMMize-1 Trial)
OptIMMize-1 Trial Summary
This trial will assess the change in disease symptoms of pediatric patients with plaque psoriasis after receiving risankizumab. There are four parts to the study, with the last part being an open-label extension for participants who continue to show improvement.
OptIMMize-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOptIMMize-1 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 2022 Phase 3 trial • 244 Patients • NCT04102007OptIMMize-1 Trial Design
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- I have been diagnosed with chronic plaque psoriasis for at least 6 months.I am eligible for drug treatment as confirmed by my doctor and meet the required health criteria.My psoriasis is stable and covers a significant part of my body.My psoriasis is stable and covers a significant part of my body.I have been diagnosed with chronic plaque psoriasis for at least 6 months.I am eligible for drug treatment as confirmed by my doctor.
- Group 1: Part 4: Risankizumab Dose A/B
- Group 2: Part 2: Risankizumab Dose A/B
- Group 3: Part 1: Risankizumab Dose A
- Group 4: Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
- Group 5: Part 3: Risankizumab Dose A/B
- 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.
- 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
What therapeutic benefits has Risankizumab been shown to provide patients?
"Risankizumab is often used as a systemic therapy for patients with certain conditions. In addition, it can help those struggling with infection, invasive procedures, and dental plaque."
Are there any other similar medical experiments that have used Risankizumab?
"As of now, 63 studies involving Risankizumab are ongoing with 32 of them in Phase 3. Out of the 5688 total locations conducting these investigations, several are based in Nice, Bretagne."
What are researchers expecting to find at the end of this clinical trial?
"According to the trial sponsor, AbbVie, the primary outcome of this study will be the percentage of participants that achieve a static Physician's Global Assessment (sPGA) of clear or almost clear. This will be measured over a 16 week period across all 4 parts of the trial. Additionally, the study will also assess secondary outcomes including change in Family Dermatology Life Quality Index (FDLQI) and percentage of participants achieving PASI 100 or PASI 75."
How many patients are participating in this research project?
"That is correct, the online information from clinicaltrials.gov verifies that this study is still looking for patients to enroll. The clinical trial was initially posted on 7/14/2020, with the most recent edit on 10/12/2022. They are looking for 132 individuals total, across 23 different sites."
Are there any restrictions for who can participate in this research project?
"This study is looking for 132 pediatric patients, aged 6 to 17, who have been diagnosed with psoriasis. In addition to this age and diagnosis criteria, patients must also have stable plaque psoriasis, as defined by the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA). They must also be candidates for systemic therapy, as assessed by the investigator, and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol."
Will this experiment be available to patients who are over 40 years old?
"The minimum age for participation in this trial is 6 years old and the age limit is 17 years old."
Can people with the qualifying health condition participate in this research?
"This study, as indicated on clinicaltrials.gov, is open for recruitment. The trial was initially posted on July 14th, 2020 and was last updated on October 12th, 2020."
Has Risankizumab gone through all the necessary channels for government approval?
"Risankizumab has efficacy data from a Phase 3 trial and multiple rounds of safety data, so it received a score of 3."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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