A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

NCT03355573 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: AS00092017-001002-15
• Study Type: interventional
• Target: 255
• Locations: 10 countries
• Sites: 50

Brief Summary

This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis

Conditions

Ankylosing Spondylitis

Keywords

Bimekizumab; Ankylosing Spondylitis; AS

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study

  An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration.

  From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)

• Percentage of Participants With Serious Adverse Event (SAE) During the Study

  A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Is a congenital anomaly or birth defect 5) Is an infection that requires treatment with parenteral antibiotics 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.

  From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)

Secondary Outcomes (4)

• Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study

  From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)

• Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008

  Baseline of AS0008, Week 48 (AS0009)

• Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008

  Baseline of AS0008, Week 48 (AS0009)

• Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48

  Baseline of AS0008, Week 48 (AS0009)

Study Arms (1)

Bimekizumab

EXPERIMENTAL

Subjects will receive bimekizumab up to 4 years.

Drug: Bimekizumab

Interventions

Bimekizumab DRUG

Bimekizumab at a prespecified dose.

Also known as: UCB4940

Bimekizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
• Subject completed AS0008 without meeting any withdrawal criteria
• Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
• Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active

You may not qualify if:

• Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP). Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
• Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
• Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into AS0009

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (50)

As0009 30

Sarasota, Florida, 34239, United States

Location

AS0009 1

Duncansville, Pennsylvania, 16635, United States

Location

AS0009 6

Dallas, Texas, 75231, United States

Location

As0009 156

Dobrich, Bulgaria

Location

As0009 151

Plovdiv, Bulgaria

Location

As0009 155

Plovdiv, Bulgaria

Location

As0009 150

Rousse, Bulgaria

Location

As0009 101

Québec, Canada

Location

As0009 205

Brno, Czechia

Location

As0009 207

Olomouc, Czechia

Location

As0009 208

Pardubice, Czechia

Location

As0009 201

Prague, Czechia

Location

As0009 202

Prague, Czechia

Location

As0009 211

Prague, Czechia

Location

As0009 210

Praha 11 Chodov, Czechia

Location

As0009 203

Zlín, Czechia

Location

As0009 304

Hamburg, Germany

Location

As0009 301

Ratingen, Germany

Location

As0009 400

Budapest, Hungary

Location

As0009 403

Budapest, Hungary

Location

As0009 401

Veszprém, Hungary

Location

As0009 466

Bydgoszcz, Poland

Location

As0009 453

Elblag, Poland

Location

As0009 456

Elblag, Poland

Location

As0009 455

Krakow, Poland

Location

As0009 461

Lublin, Poland

Location

As0009 467

Nowa Sól, Poland

Location

As0009 451

Poznan, Poland

Location

As0009 450

Torun, Poland

Location

As0009 454

Warsaw, Poland

Location

As0009 459

Warsaw, Poland

Location

As0009 457

Wroclaw, Poland

Location

As0009 460

Wroclaw, Poland

Location

As0009 465

Wroclaw, Poland

Location

As0009 601

Moscow, Russia

Location

As0009 604

Moscow, Russia

Location

As0009 607

Moscow, Russia

Location

As0009 600

Saint Petersburg, Russia

Location

As0009 606

Saint Petersburg, Russia

Location

As0009 608

Saint Petersburg, Russia

Location

As0009 610

Saint Petersburg, Russia

Location

As0009 801

A Coruña, Spain

Location

As0009 800

Córdoba, Spain

Location

As0009 803

Santiago de Compostela, Spain

Location

As0009 700

Kyiv, Ukraine

Location

As0009 707

Kyiv, Ukraine

Location

As0009 705

Ternopil, Ukraine

Location

As0009 708

Uzhhorod, Ukraine

Location

As0009 706

Vinnytsia, Ukraine

Location

As0009 704

Zaporizhzhia, Ukraine

Location

Related Publications (5)

• Baraliakos X, Deodhar A, Dougados M, Gensler LS, Molto A, Ramiro S, Kivitz AJ, Poddubnyy D, Oortgiesen M, Vaux T, Fleurinck C, Shepherd-Smith J, de la Loge C, de Peyrecave N, van der Heijde D. 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. Arthritis Rheumatol. 2022 Dec;74(12):1943-1958. doi: 10.1002/art.42282. Epub 2022 Nov 7.

  PMID: 35829672 RESULT

• Robinson PC, Machado PM, Haroon N, Gensler LS, Reveille JD, Taieb V, Vaux T, Fleurinck C, Oortgiesen M, de Peyrecave N, Deodhar A. Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study. ACR Open Rheumatol. 2022 Sep;4(9):819-824. doi: 10.1002/acr2.11486. Epub 2022 Jul 14.

  PMID: 35833532 RESULT

• Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.

  PMID: 38977276 RESULT

• Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.

  PMID: 40194794 DERIVED

• Deodhar A, Navarro-Compan V, Poddubnyy D, Gensler LS, Ramiro S, Tomita T, Marzo-Ortega H, Fleurinck C, Vaux T, Massow U, de Peyrecave N, van der Heijde D, Baraliakos X. Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension. RMD Open. 2025 Jan 31;11(1):e005081. doi: 10.1136/rmdopen-2024-005081.

  PMID: 39890205 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: November 28, 2017
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: November 21, 2024
• Results First Posted: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); CZ (8); PL (13); US (3); CA (1); BU (4); RU (7); HU (3); UA (6); DE (2)