Clinical trial NCT03347110: A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Official title: A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Bimekizumab
Psoriatic Arthritis
PsA
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-11-20
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis


Eligibility criteria: 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 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
timeFrame: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
measure: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
timeFrame: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Secondary outcomes:
measure: Percentage of Participants Who Withdrew Due to Treatment-emergent Adverse Event (TEAE) During the Study
timeFrame: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
measure: Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 Calculated Relative to Baseline of PA0008
timeFrame: Baseline of PA0008, Week 48
measure: Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 Calculated Relative to Baseline of PA0008
timeFrame: Baseline of PA0008, Week 48
measure: Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 Calculated Relative to Baseline of PA0008
timeFrame: Baseline of PA0008, Week 48
measure: Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 Calculated Relative to Baseline of PA0008
timeFrame: Baseline of PA0008, Week 48
measure: Change From Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 Calculated Relative to Baseline of PA0008
timeFrame: Baseline of PA0008, Week 48
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 Calculated Relative to Baseline of PA0008
timeFrame: Baseline of PA0008, Week 48
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 Calculated Relative to Baseline of PA0008
timeFrame: Baseline of PA0008, Week 48
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Pa0009 025
state: Kentucky
city: Hagerstown
country: United States
facility: Pa0009 003
state: Maryland
city: Lansing
country: United States
facility: Pa0009 011
state: Michigan
city: Rochester
country: United States
facility: Pa0009 028
state: New York
city: Portland
country: United States
facility: Pa0009 014
state: Oregon
city: Duncansville
country: United States
facility: Pa0009 001
state: Pennsylvania
city: Johnston
country: United States
facility: Pa0009 012
state: Rhode Island
city: Charleston
country: United States
facility: Pa0009 004
state: South Carolina
city: Jackson
country: United States
facility: Pa0009 010
state: Tennessee
city: Dallas
country: United States
facility: Pa0009 006
state: Texas
city: Mesquite
country: United States
facility: Pa0009 013
state: Texas
city: Brno
country: Czechia
facility: Pa0009 205
city: Olomouc
country: Czechia
facility: Pa0009 207
city: Praha 11
country: Czechia
facility: Pa0009 210
city: Praha 4
country: Czechia
facility: Pa0009 201
city: Praha
country: Czechia
facility: Pa0009 202
city: Zlín
country: Czechia
facility: Pa0009 203
city: Cologne
country: Germany
facility: Pa0009 302
city: Erlangen
country: Germany
facility: Pa0009 309
city: Hamburg
country: Germany
facility: Pa0009 304
city: Ratingen
country: Germany
facility: Pa0009 301
city: Budapest
country: Hungary
facility: Pa0009 403
city: Veszprém
country: Hungary
facility: Pa0009 401
city: Bialystok
country: Poland
facility: Pa0009 452
city: Elbląg
country: Poland
facility: Pa0009 453
city: Elbląg
country: Poland
facility: Pa0009 456
city: Kraków
country: Poland
facility: Pa0009 455
city: Poznań
country: Poland
facility: Pa0009 451
city: Toruń
country: Poland
facility: Pa0009 450
city: Warsaw
country: Poland
facility: Pa0009 454
city: Warsaw
country: Poland
facility: Pa0009 459
city: Wrocław
country: Poland
facility: Pa0009 465
city: Moscow
country: Russian Federation
facility: Pa0009 604
city: Moscow
country: Russian Federation
facility: Pa0009 605
city: Moscow
country: Russian Federation
facility: Pa0009 607
city: Saint Petersburg
country: Russian Federation
facility: Pa0009 606
city: Saint Petersburg
country: Russian Federation
facility: Pa0009 608
Study officials:
affiliation: +1 8445992273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.