A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants… (NCT06506916) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
United States, Germany, Poland89 participantsStarted 2024-07-29
Plain-language summary
The purpose of this study is to evaluate the effect of bimekizumab on gene expression biomarkers at Week 48 in a subset of study participants with moderate to severe plaque psoriasis (PSO) and moderate to severe plaque PSO with concomitant active psoriatic arthritis (PsA) who have provided skin biopsies for reverse transcription-polymerase chain reaction (RT-PCR).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Cohort A and Cohort B: Plaque psoriasis (PSO) diagnosed for at least 6 months prior to the Screening Visit
. Cohort B only: In addition to the criteria specified above, study participant has a documented diagnosis of adult-onset psoriatic arthritis (PsA) and meets the CASPAR classification criteria for at least 6 months prior to Screening for active PsA and must have ≥1 tender joint count (TJC) out of 68 and ≥1 swollen joint count (SJC) out of 66 at Screening or up to 3 months before Screening (documented evidence)
Exclusion criteria
. Any active systemic infection within 14 days prior to Baseline
. A serious infection, defined as requiring hospitalization or intravenous anti-infective(s) within 2 months prior to the Baseline Visit
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is already active and not recruiting new participants — does that mean I've missed the window to join, or is there any pathway for me to still be considered?
2The main thing this trial is measuring is how bimekizumab changes gene activity in psoriasis skin lesions over 48 weeks using a lab technique called RT-PCR — what does that tell us, and how is it different from trials that measure visible skin improvement like PASI scores?
3Since this is a Phase 3 trial, what do we already know about the safety profile of bimekizumab from earlier studies, and are there any side effects I should be especially aware of given my specific health history?
4The trial also includes people with psoriatic arthritis — if I have or might develop joint involvement, would that change whether this study or bimekizumab itself might be relevant to my care?
5Compared to biologics that are already approved and available to me right now, what would be the advantage or disadvantage of being part of a trial focused on understanding the biological mechanism of bimekizumab rather than just treating my symptoms?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48
. A history of opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause this study to be detrimental to the study participant
. Known active tuberculosis (TB) disease.
. History of active TB involving any organ system unless adequately treated