Back to resultsA Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis (BE ACTIVE 2)
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Bimekizumab, Psoriatic Arthritis, PsA
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
Sites / Locations
- Pa0009 025
- Pa0009 003
- Pa0009 011
- Pa0009 028
- Pa0009 014
- Pa0009 001
- Pa0009 012
- Pa0009 004
- Pa0009 010
- Pa0009 006
- Pa0009 013
- Pa0009 205
- Pa0009 207
- Pa0009 210
- Pa0009 201
- Pa0009 202
- Pa0009 203
- Pa0009 302
- Pa0009 309
- Pa0009 304
- Pa0009 301
- Pa0009 403
- Pa0009 401
- Pa0009 452
- Pa0009 453
- Pa0009 456
- Pa0009 455
- Pa0009 451
- Pa0009 450
- Pa0009 454
- Pa0009 459
- Pa0009 465
- Pa0009 604
- Pa0009 605
- Pa0009 607
- Pa0009 606
- Pa0009 608
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bimekizumab
Arm Description
Subjects will receive bimekizumab up to 2 years.
Outcomes
Primary Outcome Measures
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.
Incidence of treatment-emergent serious adverse events (SAEs) 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.) product.
Secondary Outcome Measures
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.
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 48 calculated relative to Baseline of PA0008
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0008.
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 48 calculated relative to Baseline of PA0008
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0008.
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 48 calculated relative to Baseline of PA0008
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0008.
Change from Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 calculated relative to Baseline of PA0008
The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses each scored as 0 or 1 and then summed for a possible score of 0 to 13.
Change from Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 calculated relative to Baseline of PA0008
Presence of dactylitis will be assessed using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present).
PASI75 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008
The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline in PA0008.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
PASI90 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008
The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline in PA0008.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03347110
Brief Title
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Acronym
BE ACTIVE 2
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
October 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Bimekizumab, Psoriatic Arthritis, PsA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab
Arm Type
Experimental
Arm Description
Subjects will receive bimekizumab up to 2 years.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Bimekizumab at a prespecified dose.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) during the study
Description
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.
Time Frame
From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Title
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Description
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.) product.
Time Frame
From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Secondary Outcome Measure Information:
Title
Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study
Description
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.
Time Frame
From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Title
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 48 calculated relative to Baseline of PA0008
Description
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0008.
Time Frame
Baseline of PA0008, Week 48
Title
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 48 calculated relative to Baseline of PA0008
Description
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0008.
Time Frame
Baseline of PA0008, Week 48
Title
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 48 calculated relative to Baseline of PA0008
Description
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0008.
Time Frame
Baseline of PA0008, Week 48
Title
Change from Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 calculated relative to Baseline of PA0008
Description
The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses each scored as 0 or 1 and then summed for a possible score of 0 to 13.
Time Frame
Baseline of PA0008, Week 48
Title
Change from Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 calculated relative to Baseline of PA0008
Description
Presence of dactylitis will be assessed using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present).
Time Frame
Baseline of PA0008, Week 48
Title
PASI75 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008
Description
The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline in PA0008.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Time Frame
Baseline of PA0008, Week 48
Title
PASI90 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008
Description
The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline in PA0008.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Time Frame
Baseline of PA0008, Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 8445992273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Pa0009 025
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Pa0009 003
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Pa0009 011
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Pa0009 028
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Pa0009 014
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pa0009 001
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pa0009 012
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Pa0009 004
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Pa0009 010
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Pa0009 006
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pa0009 013
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Pa0009 205
City
Brno
Country
Czechia
Facility Name
Pa0009 207
City
Olomouc
Country
Czechia
Facility Name
Pa0009 210
City
Praha 11
Country
Czechia
Facility Name
Pa0009 201
City
Praha 4
Country
Czechia
Facility Name
Pa0009 202
City
Praha
Country
Czechia
Facility Name
Pa0009 203
City
Zlín
Country
Czechia
Facility Name
Pa0009 302
City
Cologne
Country
Germany
Facility Name
Pa0009 309
City
Erlangen
Country
Germany
Facility Name
Pa0009 304
City
Hamburg
Country
Germany
Facility Name
Pa0009 301
City
Ratingen
Country
Germany
Facility Name
Pa0009 403
City
Budapest
Country
Hungary
Facility Name
Pa0009 401
City
Veszprém
Country
Hungary
Facility Name
Pa0009 452
City
Bialystok
Country
Poland
Facility Name
Pa0009 453
City
Elbląg
Country
Poland
Facility Name
Pa0009 456
City
Elbląg
Country
Poland
Facility Name
Pa0009 455
City
Kraków
Country
Poland
Facility Name
Pa0009 451
City
Poznań
Country
Poland
Facility Name
Pa0009 450
City
Toruń
Country
Poland
Facility Name
Pa0009 454
City
Warsaw
Country
Poland
Facility Name
Pa0009 459
City
Warsaw
Country
Poland
Facility Name
Pa0009 465
City
Wrocław
Country
Poland
Facility Name
Pa0009 604
City
Moscow
Country
Russian Federation
Facility Name
Pa0009 605
City
Moscow
Country
Russian Federation
Facility Name
Pa0009 607
City
Moscow
Country
Russian Federation
Facility Name
Pa0009 606
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0009 608
City
Saint Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35789257
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.
Results Reference
result
Learn more about this trial
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
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