Bimekizumab for Psoriatic Arthritis

Recruiting at 118 trial locations

Overseen By UCB Cares

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Must be taking: CsDMARDs

Must not be taking: JAK inhibitors

Disqualifiers: Active infection, Tuberculosis, Rheumatoid arthritis, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

550 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain medications like methotrexate, sulfasalazine, and NSAIDs, but you may need to stop other PsA medications if they don't meet the required washout period (time without taking certain medications) before the study starts. It's best to discuss your specific medications with the study team.

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

Research shows that Bimekizumab, a drug that blocks certain proteins involved in inflammation, is more effective than a placebo in reducing symptoms of psoriatic arthritis, especially in patients who haven't used other similar treatments before. Studies also indicate that it remains effective and safe over a longer period, up to 52 weeks. ^{1 2 3 4 5}

Is Bimekizumab safe for humans?

Bimekizumab has been shown to be safe and well-tolerated in clinical trials for conditions like psoriatic arthritis and psoriasis, with no significant adverse events reported. ^{1 3 5 6 7}

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 potentially more effective for people who haven't responded well to other treatments. ^{1 2 3 5 7}

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

This trial is for adults with active Psoriatic Arthritis diagnosed at least 6 months ago, who have not responded well to or tolerated previous treatments. Participants must have at least 3 tender and swollen joints and one psoriatic skin lesion or a history of plaque-type psoriasis.

Inclusion Criteria

I have been diagnosed with PsA for at least 6 months and still have active symptoms despite treatment.

I have at least one active psoriasis lesion or a history of chronic plaque psoriasis.

I have tried at least one csDMARD for my condition without enough improvement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bimekizumab or risankizumab for 16 weeks to evaluate efficacy and safety

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 42 weeks

Treatment Details

Interventions

• Bimekizumab

Trial Overview The study aims to compare the effectiveness of two drugs, Bimekizumab and Risankizumab, over a period of 16 weeks in treating Psoriatic Arthritis. Some participants will receive a placebo instead as part of the control group.

Participant Groups

Group I: Bimekizumab Experimental Treatment 2 Interventions

Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period.

Group II: Risankizumab Active Control 2 Interventions

Study participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period.

Bimekizumab is already approved in European Union, United States for the following indications:

Approved in European Union as Bimzelx for:

• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Non-radiographic axial spondyloarthritis
• Active ankylosing spondylitis

Approved in United States as Bimzelx for:

• Moderate-to-severe plaque psoriasis
• Active psoriatic arthritis
• Non-radiographic axial spondyloarthritis
• Active ankylosing spondylitis
• Hidradenitis suppurativa

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

Bimekizumab (BKZ) demonstrated sustained efficacy in treating active psoriatic arthritis (PsA) from Week 16 to Week 52, maintaining significant improvements in ACR response criteria and psoriasis severity measures.

The treatment was well tolerated, with a similar rate of treatment-emergent adverse events (TEAEs) compared to adalimumab, and no new safety concerns were identified, although localized Candida infections were noted in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ritchlin, CT., Coates, LC., McInnes, IB., 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]

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, a new biologic targeting both IL-17A and IL-17F, has shown significant promise in phase II clinical trials for treating psoriasis and psoriatic arthritis, with rapid symptom resolution observed in some patients within just two weeks.

The drug has demonstrated a favorable safety profile, being well-tolerated by patients without significant adverse events, and is currently undergoing further evaluation in phase III clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab for the treatment of psoriatic disease. Natsis, NE., Gottlieb, AB.[2019]

Bimekizumab (BKZ) showed sustained efficacy in treating both non-radiographic and radiographic axial spondyloarthritis over 52 weeks, maintaining improvements in key measures like disease activity and inflammation levels.

The safety profile of BKZ remained consistent, with 75% of patients experiencing treatment-emergent adverse events, but serious events were relatively low, indicating it is a safe option for long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Baraliakos, X., Deodhar, A., van der Heijde, D., et al.[2023]

References

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

Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. [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 Psoriatic Arthritis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. [2023]

5. 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]

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

Bimekizumab for the treatment of psoriatic disease. [2019]

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

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. [2023]