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

Ankylosing Spondylitis Clinical Trial

— BE AGILE 2  

Official title:

A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355573
• Other study ID #: AS0009
• Secondary ID: 2017-001002-15
• Status: Completed
• Phase: Phase 2
• Start date: November 28, 2017
• Est. completion date: October 19, 2022

Study information

• Verified date: October 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: October 19, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Bimekizumab
Bimekizumab at a prespecified dose.

Locations

Country	Name	City	State
Bulgaria	As0009 156	Dobrich
Bulgaria	As0009 151	Plovdiv
Bulgaria	As0009 155	Plovdiv
Bulgaria	As0009 150	Ruse
Canada	As0009 101	Quebec City
Czechia	As0009 205	Brno
Czechia	As0009 207	Olomouc
Czechia	As0009 208	Pardubice
Czechia	As0009 202	Praha
Czechia	As0009 210	Praha 11 Chodov
Czechia	As0009 211	Praha 3
Czechia	As0009 201	Praha 4
Czechia	As0009 203	Zlin
Germany	As0009 304	Hamburg
Germany	As0009 301	Ratingen
Hungary	As0009 400	Budapest
Hungary	As0009 403	Budapest
Hungary	As0009 401	Veszprem
Poland	As0009 466	Bydgoszcz
Poland	As0009 453	Elblag
Poland	As0009 456	Elblag
Poland	As0009 455	Krakow
Poland	As0009 461	Lublin
Poland	As0009 467	Nowa Sol
Poland	As0009 451	Poznan
Poland	As0009 450	Torun
Poland	As0009 454	Warszawa
Poland	As0009 459	Warszawa
Poland	As0009 457	Wroclaw
Poland	As0009 460	Wroclaw
Poland	As0009 465	Wroclaw
Russian Federation	As0009 601	Moscow
Russian Federation	As0009 604	Moscow
Russian Federation	As0009 607	Moscow
Russian Federation	As0009 600	Saint Petersburg
Russian Federation	As0009 606	Saint Petersburg
Russian Federation	As0009 608	Saint Petersburg
Russian Federation	As0009 610	Saint-petersburg
Spain	As0009 801	A Coruna
Spain	As0009 800	Cordoba
Spain	As0009 803	Santiago de Compostela
Ukraine	As0009 700	Kyiv
Ukraine	As0009 707	Kyiv
Ukraine	As0009 705	Ternopil
Ukraine	As0009 708	Uzhgorod
Ukraine	As0009 706	Vinnytsia
Ukraine	As0009 704	Zaporizhzhia
United States	AS0009 6	Dallas	Texas
United States	AS0009 1	Duncansville	Pennsylvania
United States	As0009 30	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Germany,  Hungary,  Poland,  Russian Federation,  Spain,  Ukraine, 

References & Publications (2)

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 Ank — View Citation

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs) during the study	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.	From Entry Visit (Visit 1) until Last Visit (up to Week 208)
Primary	Incidence of serious adverse event (SAE) during the study	Once it is determined that a subject experienced an Adverse Event (AE), the seriousness of the AE must be determined. An SAE must meet 1 or more of the following criteria: death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.	From Entry Visit (Visit 1) until Last Visit (up to Week 208)
Secondary	Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.	From Entry Visit (Visit 1) until Last Visit (up to Week 208)
Secondary	Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline of AS0008	ASAS40 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.; The domains are: Patient's Global Assessment of Disease Activity (PGADA); Pain assessment (the total spinal pain, NRS score); Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)); Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))	Baseline of AS0008, Week 48
Secondary	Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008	ASAS20 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.; The domains are: Patient's Global Assessment of Disease Activity (PGADA); Pain assessment (the total spinal pain, NRS score); Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)); Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))	Baseline of AS0008, Week 48
Secondary	Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48	The Bath ankylosing spondylitis disease activity index (BASDAI) is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.	Baseline of AS0008, Week 48