Bimekizumab for Ankylosing Spondylitis

(BE MOVING Trial)

Not currently recruiting at 109 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Disqualifiers: Pregnancy, Serious infections, 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: 112 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called bimekizumab (also known as Bimzelx, bimekizumab-bkzx, or UCB4940) for individuals with active axial spondyloarthritis, a condition causing painful inflammation in the spine and pelvis. The trial aims to assess the long-term safety and effectiveness of bimekizumab. It specifically targets those who have participated in certain previous studies. Individuals with this condition who have taken part in these past studies might be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that bimekizumab remains consistently safe over time. After 5 years of use, no new safety issues emerged. For people with ankylosing spondylitis, the most common side effects are mild and include colds, oral yeast infections, headaches, and diarrhea. Considering these factors is important when deciding to join a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ankylosing spondylitis?

Bimekizumab is unique because it targets both IL-17A and IL-17F, two proteins involved in inflammation, while most current treatments for ankylosing spondylitis, like TNF inhibitors, only target TNF-alpha. This dual action has the potential to reduce inflammation more effectively, offering better symptom control for patients. Researchers are excited because this could mean improved outcomes for those who don't fully respond to existing therapies.

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

Research has shown that bimekizumab holds promise for treating ankylosing spondylitis. Studies found that over 40% of people taking bimekizumab experienced at least a 40% improvement in back pain, stiffness, and spinal inflammation within 16 weeks. Long-term evidence also indicates that bimekizumab effectively controls inflammation in conditions like axial spondyloarthritis, which includes ankylosing spondylitis. Additionally, the safety of bimekizumab has remained stable, with no new safety issues identified after five years of use. These findings suggest that bimekizumab could effectively manage ankylosing spondylitis symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Are You a Good Fit for This Trial?

This trial is for people with active axial spondyloarthritis, including ankylosing spondylitis and nonradiographic forms. Participants must have completed previous related studies (AS0010 or AS0011), be reliable in following the study protocol, and are expected to benefit from it. Those with ongoing serious adverse events, serious infections history, or positive IGRA tests need medical consultation before joining.

Inclusion Criteria

Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study

I can follow the study's schedule and take medications as directed.

Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)

Exclusion Criteria

I do not plan to become pregnant during the study or within 5 months after the last dose.

I have a positive or unclear TB test result but have been checked or treated.

I am a male and may plan to father a child during the study or within 5 months after it ends.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimekizumab to assess long-term safety, tolerability, and efficacy

112 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 68 weeks

Open-label extension

Participants may continue receiving bimekizumab to further assess long-term outcomes

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Bimekizumab

Trial Overview The trial is testing Bimekizumab's long-term safety, tolerability, and effectiveness in treating axial spondyloarthritis conditions like ankylosing spondylitis. It aims to show how well patients do over a longer period while taking this medication.

How Is the Trial Designed?

Group I: Bimekizumab Experimental Treatment 1 Intervention

Subjects will receive bimekizumab throughout the 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

Published Research Related to This Trial

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]

In the BUILDER-1 trial, tocilizumab (TCZ) did not show significant efficacy in improving symptoms of ankylosing spondylitis (AS) in patients who had not previously received anti-TNF treatment, with ASAS20 response rates of 37.3% for TCZ compared to 27.5% for placebo.

Safety results for TCZ were generally consistent with previous studies in rheumatoid arthritis, but there was a concerning cluster of anaphylactic and hypersensitivity reactions at specific study sites in Bulgaria, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Sieper, J., Porter-Brown, B., Thompson, L., et al.[2023]

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]

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 ... “This data presented at ACR shows that bimekizumab-bkzx continues to demonstrate long-term improvement in inflammation control and deep efficacy ...

2. ucb-usa.com ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelxr-bimekizumab-bkzx-three-year-data-at-eular-2025-showed-lasting-efficacy-and-control-of-inflammation-in-psoriatic-arthritis-and-axial-spondyloarthritis

BIMZELX® (bimekizumab-bkzx) Three-Year Data at ... BIMZELX (bimekizumab-bkzx) three-year data at EULAR 2025 showed lasting efficacy and control of inflammation in psoriatic arthritis and axial spondyloarthritis.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK610038/

Clinical Review - Bimekizumab (Bimzelx) - NCBI Bookshelf - NIH Positive top-line results for Bimzelx (bimekizumab) in phase 3 ankylosing spondylitis trial. 2023: https://www​.ucb.com/stories-media​/Press-Releases ...

4. bimzelx.com bimzelx.com/ankylosing-spondylitis/bimzelx/results

What could transformative relief mean to you? More than 4 in 10 people taking BIMZELX saw at least 40% improvement in back pain, stiffness, and spinal inflammation at 16 weeks vs about 2 in 10 taking ...

5. rmdopen.bmj.com rmdopen.bmj.com/content/11/1/e005081

Long-term safety and sustained efficacy of bimekizumab in ... The safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39890205/

Long-term safety and sustained efficacy of bimekizumab in ... The safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified.

7. bimzelxhcp.com bimzelxhcp.com/rheumatology/Safety

Safety Profile|BIMZELX® (bimekizumab-bkzx) Most common (≥2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04436640

NCT04436640 | A Study to Evaluate the Long-term Safety, ... The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis.