A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Study Evaluates Bimekizumab for Severe Psoriasis in Children
Plain English Summary
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis is a Phase 3 clinical trial sponsored by UCB Biopharma SRL studying Moderate to Severe Plaque Psoriasis. Tests bimekizumab, a new drug, against ustekinumab for treating severe plaque psoriasis in children aged 6-17. For participation, children must have moderate to severe psoriasis and be at least 6 years old. Involves regular doctor visits and injections, with a 16-week follow-up period. Alternatives include other biologic treatments and systemic therapies. The trial aims to enroll 168 participants.
Official Summary
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if 6-17 years old, diagnosed with moderate to severe psoriasis for at least 3 months. Must weigh at least 15 kg and have a body mass index for age percentile of at least 5. Cannot have previously received bimekizumab, ustekinumab, or other biologics for psoriasis. Cannot have active infections, inflammatory bowel disease, or psychiatric conditions. This trial is studying Moderate to Severe Plaque Psoriasis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
Measures include PASI90 and IGA0/1 responses, indicating significant improvement in psoriasis symptoms and skin appearance. The specific primary outcome measures are: Psoriasis Area Severity Index 90 (PASI90) response at Week 16 (Week 16); Investigator´s Global Assessment (IGA) 0/1 response at Week 16 (Week 16). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial fills a gap by evaluating a new treatment option for severe psoriasis in children, offering hope for better management. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Moderate to Severe Plaque Psoriasis, where improved treatment options are needed.
Investor Insight
Addresses a large market need, with limited options for severe psoriasis in children, and a competitive landscape with few ongoing trials. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor about the risks and benefits of participating in the study. Involves regular doctor visits and injections, with a 16-week follow-up period. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 168 participants
Interventions
- DRUG: bimekizumab — Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
- DRUG: ustekinumab — Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
- DRUG: placebo — Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.
Primary Outcomes
- Psoriasis Area Severity Index 90 (PASI90) response at Week 16 (Week 16)
- Investigator´s Global Assessment (IGA) 0/1 response at Week 16 (Week 16)
Secondary Outcomes
- PASI75 response at Week 4 (Week 4)
- PASI100 response at Week 16 (Week 16)
- PASI90 response at Week 48 (Week 48)
- IGA 0/1 response at Week 48 (Week 48)
- PASI100 response at Week 48 (Week 48)
Full Eligibility Criteria
Inclusion Criteria: * Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation * Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit * Study participant meets the following at both the Screening and Baseline Visits: 1. Body surface area (BSA) affected by PSO ≥10% 2. . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) 3. . Psoriasis Area and Severity Index (PASI) score ≥12 OR PASI score ≥10 plus at least 1 of the following: i) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement * Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling * Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening Exclusion Criteria: * Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17 * Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO * Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD * History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated * Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) * Study participant has previously received bimekizumab * Study participant has previously received ustekinumab * Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments * Study participant has the presence of active suicidal ideation, or positive suicide behavior * Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded * Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study
Trial Locations
- Ps0021 50162, Fountain Valley, California, United States
- Ps0021 50161, Los Angeles, California, United States
- Ps0021 50196, Northridge, California, United States
- Ps0021 50581, Miami, Florida, United States
- Ps0021 50344, Indianapolis, Indiana, United States
- Ps0021 50599, Kew Gardens, New York, United States
- Ps0021 50084, Charleston, South Carolina, United States
- Ps0021 50201, Arlington, Texas, United States
- Ps0021 50355, Dallas, Texas, United States
- Ps0021 40121, Brussels, Belgium
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06425549?
NCT06425549 is a Phase 3 INTERVENTIONAL study titled "A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis." It is currently recruiting and is sponsored by UCB Biopharma SRL. The trial targets enrollment of 168 participants.
What conditions does NCT06425549 study?
This trial investigates treatments for Moderate to Severe Plaque Psoriasis. The primary condition under study is Moderate to Severe Plaque Psoriasis.
What treatments are being tested in NCT06425549?
The interventions being studied include: bimekizumab (DRUG), ustekinumab (DRUG), placebo (DRUG). Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
What does Phase 3 mean for NCT06425549?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06425549?
This trial is currently "Recruiting." It started on 2024-06-25. The estimated completion date is 2030-11-08.
Who is sponsoring NCT06425549?
NCT06425549 is sponsored by UCB Biopharma SRL. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06425549?
The trial aims to enroll 168 participants. The trial is currently recruiting and accepting new participants.
How is NCT06425549 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06425549?
The primary outcome measures are: Psoriasis Area Severity Index 90 (PASI90) response at Week 16 (Week 16); Investigator´s Global Assessment (IGA) 0/1 response at Week 16 (Week 16). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06425549 being conducted?
This trial is being conducted at 20 sites, including Fountain Valley, California; Los Angeles, California; Northridge, California; Miami, Florida and 16 more sites (United States, Belgium, Canada).
Where can I find official information about NCT06425549?
The official record for NCT06425549 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06425549. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06425549 testing in simple terms?
Tests bimekizumab, a new drug, against ustekinumab for treating severe plaque psoriasis in children aged 6-17. For participation, children must have moderate to severe psoriasis and be at least 6 years old.
Why is this trial significant?
This trial fills a gap by evaluating a new treatment option for severe psoriasis in children, offering hope for better management. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06425549?
Potential side effects include injection site reactions, infections, and psychiatric symptoms. Monitor for any unusual symptoms and report them to your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06425549?
Ask your doctor about the risks and benefits of participating in the study. Involves regular doctor visits and injections, with a 16-week follow-up period. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06425549 signal from an investment perspective?
Addresses a large market need, with limited options for severe psoriasis in children, and a competitive landscape with few ongoing trials. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Involves regular doctor visits and injections, with a 16-week follow-up period. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.