Bimekizumab for Enthesitis Related and Psoriatic Arthritis

Recruiting at 15 trial locations

Overseen By UCB Cares

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Must not be taking: IL-17 biologics

Disqualifiers: IBD, Uncontrolled uveitis, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial allows participants to continue taking methotrexate or sulfasalazine if they have been on a stable dose for a certain period before starting the trial. However, other second-line medications are not allowed, so you may need to stop those.

What data supports the effectiveness of the drug Bimekizumab for treating enthesitis related and psoriatic arthritis?

Research shows that Bimekizumab is effective in treating psoriatic arthritis, as it helps reduce inflammation by blocking specific proteins (IL-17A and IL-17F) involved in the immune response. Studies have demonstrated its safety and effectiveness in patients with psoriatic arthritis, including those who have not responded well to other treatments. ^{1 2 3 4 5}

Is Bimekizumab safe for humans?

Bimekizumab has been studied for safety in people with psoriatic arthritis, and research shows it is generally safe for human use. However, like any medication, it may have side effects, and its safety profile is based on studies in specific conditions. ^{1 2 3 5 6}

How is the drug Bimekizumab different from other treatments for psoriatic arthritis?

Bimekizumab is unique because it targets and blocks two specific proteins, interleukin-17A and interleukin-17F, which are involved in inflammation, making it a novel approach compared to other treatments that may only target one of these proteins. ^{1 2 3 5 7}

What is the purpose of this trial?

The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

Children and teenagers aged 2 to <18 with juvenile idiopathic arthritis subtypes, including enthesitis-related arthritis and juvenile psoriatic arthritis. They must weigh at least 10kg, have active disease, and not be on certain second-line drugs except for stable doses of methotrexate or sulfasalazine. Girls who can have babies must agree to use birth control during the study.

Inclusion Criteria

1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive guidance during the Initial Treatment Period, the Open-label Extension (OLE) Period, and for at least 20 weeks after the final dose of investigational medicinal product (IMP; ie, the Safety Follow-up (SFU) Period)

I have tried an NSAID for over a month without enough relief or I cannot tolerate them.

I have been on a stable dose of methotrexate or sulfasalazine for the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive subcutaneous bimekizumab administration to assess plasma concentrations

16 weeks

Multiple visits for plasma sample collection

Safety Follow-up

Participants are monitored for treatment-emergent adverse events and other safety measures

Up to 141 weeks

Treatment Details

Interventions

• Bimekizumab

Trial Overview The trial is testing Bimekizumab given under the skin to see how it's processed in the body (pharmacokinetics) and its safety in young patients with specific types of juvenile idiopathic arthritis.

Participant Groups

Group I: Bimekizumab Experimental Treatment 1 Intervention

Study participants will receive a bimekizumab dose which is dependent on their weight.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Findings from Research

In a 52-week phase 3 trial involving 852 patients with active psoriatic arthritis, bimekizumab demonstrated significantly greater efficacy than placebo, with 44% of patients achieving a 50% improvement in symptoms (ACR50) at week 16 compared to only 10% in the placebo group.

The safety profile of bimekizumab was consistent with previous studies, showing a similar rate of treatment-emergent adverse events compared to adalimumab, with no deaths reported, indicating it is a safe option for patients new to biologic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). McInnes, IB., Asahina, A., Coates, LC., et al.[2023]

In a phase 3 trial involving 400 patients with active psoriatic arthritis who had previously not responded to TNFα inhibitors, bimekizumab significantly improved joint symptoms, with 43% of patients achieving a 50% improvement in ACR criteria compared to only 7% in the placebo group.

Bimekizumab also showed remarkable efficacy in skin symptoms, with 69% of patients achieving at least a 90% improvement in psoriasis severity, while the placebo group had only 7% reaching this level, indicating strong therapeutic potential for both joint and skin manifestations of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Merola, JF., Landewé, R., McInnes, IB., et al.[2023]

Bimekizumab significantly improved joint and skin symptoms in patients with psoriatic arthritis, with a higher percentage of participants meeting the American College of Rheumatology 50 threshold compared to placebo (RR = 4.94).

The treatment was found to have a similar safety profile to placebo, with no significant difference in treatment-emergent adverse events (RR = 1.08), indicating it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis and GRADE assessment of randomized controlled trials on the efficacy and safety of bimekizumab in psoriatic arthritis patients. Mahmoud, AM.[2023]

Bimekizumab demonstrated a long-term safety profile in patients with active psoriatic arthritis over 152 weeks, with no new safety concerns identified; the most common adverse events were mild and included nasopharyngitis and upper respiratory infections.

Efficacy was sustained over the 3-year period, with over half of the patients achieving significant improvements in joint symptoms and skin clearance, indicating that bimekizumab is an effective long-term treatment option for psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Bimekizumab in Patients With Active Psoriatic Arthritis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. Coates, LC., McInnes, IB., Merola, JF., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). [2023]

2. England pubmed.ncbi.nlm.nih.gov

Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). [2023]

3. England pubmed.ncbi.nlm.nih.gov

Meta-analysis and GRADE assessment of randomized controlled trials on the efficacy and safety of bimekizumab in psoriatic arthritis patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Bimekizumab in Patients With Active Psoriatic Arthritis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Anti-TNF-α therapy induced psoriasis in rheumatoid arthritis patients according to FDA postmarketing surveillance data. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study. [2021]