A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
BE ACTIVE 2
A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
2 other identifiers
interventional
184
6 countries
37
Brief Summary
This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2017
Typical duration for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2017
CompletedFirst Posted
Study publicly available on registry
November 20, 2017
CompletedStudy Start
First participant enrolled
November 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2020
CompletedResults Posted
Study results publicly available
December 1, 2023
CompletedDecember 1, 2023
November 1, 2023
2.9 years
November 15, 2017
October 26, 2023
November 29, 2023
Conditions
Keywords
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. TEAEs were defined as events with onset date on or after the start date of study medication in PA0009.
From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in 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 of PA0009 until Safety Follow-Up Visit (up to Week 120)
Secondary Outcomes (8)
Percentage of Participants Who Withdrew Due to Treatment-emergent Adverse Event (TEAE) During the Study
From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 Calculated Relative to Baseline of PA0008
Baseline of PA0008, Week 48
Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 Calculated Relative to Baseline of PA0008
Baseline of PA0008, Week 48
Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 Calculated Relative to Baseline of PA0008
Baseline of PA0008, Week 48
Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 Calculated Relative to Baseline of PA0008
Baseline of PA0008, Week 48
- +3 more secondary outcomes
Study Arms (1)
Bimekizumab
EXPERIMENTALSubjects will receive bimekizumab up to 2 years.
Interventions
Eligibility Criteria
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 PA0008 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 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 PA0008. 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 PA0009
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Pa0009 025
Lexington, Kentucky, 40504, United States
Pa0009 003
Hagerstown, Maryland, 21502, United States
Pa0009 011
Lansing, Michigan, 48910, United States
Pa0009 028
Rochester, New York, 14642, United States
Pa0009 014
Portland, Oregon, 97239, United States
Pa0009 001
Duncansville, Pennsylvania, 16635, United States
Pa0009 012
Johnston, Rhode Island, 02919, United States
Pa0009 004
Charleston, South Carolina, 29406, United States
Pa0009 010
Jackson, Tennessee, 38305, United States
Pa0009 006
Dallas, Texas, 75231, United States
Pa0009 013
Mesquite, Texas, 75150, United States
Pa0009 205
Brno, Czechia
Pa0009 207
Olomouc, Czechia
Pa0009 201
Prague, Czechia
Pa0009 202
Prague, Czechia
Pa0009 210
Prague, Czechia
Pa0009 203
Zlín, Czechia
Pa0009 302
Cologne, Germany
Pa0009 309
Erlangen, Germany
Pa0009 304
Hamburg, Germany
Pa0009 301
Ratingen, Germany
Pa0009 403
Budapest, Hungary
Pa0009 401
Veszprém, Hungary
Pa0009 452
Bialystok, Poland
Pa0009 453
Elblag, Poland
Pa0009 456
Elblag, Poland
Pa0009 455
Krakow, Poland
Pa0009 451
Poznan, Poland
Pa0009 450
Torun, Poland
Pa0009 454
Warsaw, Poland
Pa0009 459
Warsaw, Poland
Pa0009 465
Wroclaw, Poland
Pa0009 604
Moscow, Russia
Pa0009 605
Moscow, Russia
Pa0009 607
Moscow, Russia
Pa0009 606
Saint Petersburg, Russia
Pa0009 608
Saint Petersburg, Russia
Related Publications (3)
Mease PJ, Asahina A, Gladman DD, Tanaka Y, Tillett W, Ink B, Assudani D, de la Loge C, Coarse J, Eells J, Gossec L. Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE. Rheumatology (Oxford). 2023 Feb 1;62(2):617-628. doi: 10.1093/rheumatology/keac353.
PMID: 35789257RESULTMease 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: 40194794DERIVEDCoates LC, McInnes IB, Merola JF, Warren RB, Kavanaugh A, Gottlieb AB, Gossec L, Assudani D, Bajracharya R, Coarse J, Ink B, Ritchlin CT. 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. Arthritis Rheumatol. 2022 Dec;74(12):1959-1970. doi: 10.1002/art.42280. Epub 2022 Nov 18.
PMID: 35829656DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 8445992273 (UCB)
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 15, 2017
First Posted
November 20, 2017
Study Start
November 22, 2017
Primary Completion
October 29, 2020
Study Completion
October 29, 2020
Last Updated
December 1, 2023
Results First Posted
December 1, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share