Bimekizumab for Enthesitis Related and Psoriatic Arthritis

Recruiting at 26 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how the drug bimekizumab behaves in the body when administered as an injection under the skin. It focuses on children and teens with specific types of arthritis that cause joint pain and swelling, such as enthesitis-related arthritis and juvenile psoriatic arthritis. The trial seeks participants who have these conditions, have not responded well to other treatments like NSAIDs, and have at least three swollen joints and one painful spot where tendons attach to bones. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that bimekizumab is likely to be safe for humans?

Research has shown that bimekizumab is generally safe for use. In studies, patients took bimekizumab for up to two years without any new side effects appearing. This indicates that no unexpected side effects were reported during this period. Other research suggests that bimekizumab is a safe treatment for conditions like psoriatic arthritis (a type of arthritis linked to skin psoriasis) for up to one year. Overall, the treatment appears safe and has been studied for extended periods, providing researchers with a clear understanding of expected side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about bimekizumab for treating enthesitis-related and psoriatic arthritis because it offers a unique approach compared to standard treatments like TNF inhibitors and methotrexate. Unlike these options, bimekizumab targets both IL-17A and IL-17F, two proteins involved in inflammatory processes, which could provide more comprehensive inflammation control. This dual inhibition might lead to more effective symptom relief and improved outcomes for patients who don't respond well to current therapies. Additionally, bimekizumab's targeted action might result in fewer side effects, offering a promising alternative for managing these conditions.

What evidence suggests that bimekizumab might be an effective treatment for arthritis?

Research has shown that bimekizumab effectively treats psoriatic arthritis (PsA). Studies have found it reduces symptoms such as joint pain and swelling. In one study, 72.5% of patients experienced significant symptom improvement. Bimekizumab also alleviated dactylitis and enthesitis, painful conditions affecting the fingers and tendons. These improvements persisted, with some patients benefiting for up to three years. This trial will evaluate bimekizumab as a promising option for managing PsA symptoms. ^{2 3 4 6 7}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

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 been diagnosed with ERA or JPsA for at least 6 months.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. ucb.com ucb.com/newsroom/press-releases/article/bimzelxr-bimekizumab-bkzx-three-year-rheumatology-data-at-acr-2025-demonstrated-sustained-inflammation-control-in-psoriatic-arthritis-and-axial-spondyloarthritis

BIMZELX[®] (bimekizumab-bkzx) three year rheumatology ... In patients with PsA, one-year improvements were sustained to three years across the following GRAPPA domains:* peripheral arthritis, dactylitis, enthesitis, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12450189/

Real-World Effectiveness of Bimekizumab in Predominantly ... BKZ demonstrated robust efficacy, with 72.5% of patients achieving Disease Activity in Psoriatic Arthritis (DAPSA) low disease activity (LDA) ...

3. thelancet.com thelancet.com/journals/lancet/article/piis0140-6736(22)02302-9/fulltext

Bimekizumab in patients with psoriatic arthritis, naive to ... Pooled data showed that bimekizumab treatment was associated with resolution of dactylitis and enthesitis in high proportions of patients with these symptoms.

4. jrheum.org jrheum.org/content/52/Suppl_2/28

Bimekizumab Maintained Efficacy Responses in Patients ... Conclusion BKZ demonstrated robust maintenance of response at 2 years in both bDMARD-naïve and TNFi-IR pts with PsA who responded to BKZ ...

5. rmdopen.bmj.com rmdopen.bmj.com/content/10/1/e003855

Bimekizumab treatment in patients with active psoriatic ... Patients receiving bimekizumab from week 0 demonstrated sustained improvements in clinical outcomes from week 16 to ‍52 across core PsA disease ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11422409/

Safety and Efficacy of Bimekizumab in Patients with ... Bimekizumab was well tolerated for up to 2 years of treatment and no new safety signals were observed. Sustained clinical efficacy was observed up to 2 years.

7. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr2.11727

Efficacy and Safety of Bimekizumab in Patients With Psoriatic ... In conclusion, treatment with bimekizumab demonstrated consistent, sustained clinical efficacy to 52 weeks in bDMARD-naïve and TNFi-IR patients ...