A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347110
• Other study ID #: PA0009
• Secondary ID: 2017-001003-74
• Status: Completed
• Phase: Phase 2
• Start date: November 22, 2017
• Est. completion date: October 29, 2020

Study information

• Verified date: November 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 psoriatic arthritis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• 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 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Bimekizumab
Bimekizumab at a prespecified dose.

Locations

Country	Name	City	State
Czechia	Pa0009 205	Brno
Czechia	Pa0009 207	Olomouc
Czechia	Pa0009 202	Praha
Czechia	Pa0009 210	Praha 11
Czechia	Pa0009 201	Praha 4
Czechia	Pa0009 203	Zlín
Germany	Pa0009 302	Cologne
Germany	Pa0009 309	Erlangen
Germany	Pa0009 304	Hamburg
Germany	Pa0009 301	Ratingen
Hungary	Pa0009 403	Budapest
Hungary	Pa0009 401	Veszprém
Poland	Pa0009 452	Bialystok
Poland	Pa0009 453	Elblag
Poland	Pa0009 456	Elblag
Poland	Pa0009 455	Kraków
Poland	Pa0009 451	Poznan
Poland	Pa0009 450	Torun
Poland	Pa0009 454	Warsaw
Poland	Pa0009 459	Warsaw
Poland	Pa0009 465	Wroclaw
Russian Federation	Pa0009 604	Moscow
Russian Federation	Pa0009 605	Moscow
Russian Federation	Pa0009 607	Moscow
Russian Federation	Pa0009 606	Saint Petersburg
Russian Federation	Pa0009 608	Saint Petersburg
United States	Pa0009 004	Charleston	South Carolina
United States	Pa0009 006	Dallas	Texas
United States	Pa0009 001	Duncansville	Pennsylvania
United States	Pa0009 003	Hagerstown	Maryland
United States	Pa0009 010	Jackson	Tennessee
United States	Pa0009 012	Johnston	Rhode Island
United States	Pa0009 011	Lansing	Michigan
United States	Pa0009 025	Lexington	Kentucky
United States	Pa0009 013	Mesquite	Texas
United States	Pa0009 014	Portland	Oregon
United States	Pa0009 028	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Hungary,  Poland,  Russian Federation, 

References & Publications (1)

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. Rheumato — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Percentage of Participants Who Withdrew Due to Treatment-emergent Adverse Event (TEAE) During the Study	An adverse event (AE) is any untoward medical occurrence in a patient 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.	From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
Secondary	Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 Calculated Relative to Baseline of PA0008	The ACR20 response rate was based on 20% or greater improvement relative to Baseline of PA0008 in the following measures: Tender Joint Count (TJC) based on 78 joints, Swollen Joint Count (SJC) based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA), Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA), Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP), Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI), Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP). Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.	Baseline of PA0008, Week 48
Secondary	Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 Calculated Relative to Baseline of PA0008	The ACR50 response rate was based on 50% or greater improvement relative to Baseline of PA0008 in the following measures: TJC based on 78 joints, SJC based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by PGADA, Disease activity as assessed by PhGADA, Pain as assessed by PtAAP, Physical function as assessed by HAQ-DI, Acute phase response as assessed by hs CRP. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.	Baseline of PA0008, Week 48
Secondary	Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 Calculated Relative to Baseline of PA0008	The ACR70 response rate was based on 70% or greater improvement relative to Baseline of PA0008 in the following measures: TJC based on 78 joints, SJC based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by PGADA, Disease activity as assessed by PhGADA, Pain as assessed by PtAAP, Physical function as assessed by HAQ-DI, Acute phase response as assessed by hs CRP. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.	Baseline of PA0008, Week 48
Secondary	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 (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process). Each item was scored as 0 = not tender or 1 = tender and then were summed for a possible score of 0 to 13, with higher scores indicating worse enthesitis. If 7 or more items were available, MASES was calculated by dividing the summed score with the number of assessments and multiplying the result by 13. If less than 7 items were available, MASES was treated as missing.	Baseline of PA0008, Week 48
Secondary	Change From Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 Calculated Relative to Baseline of PA0008	Presence of dactylitis was assessed using the LDI basic which evaluated for a greater than or equal to (>=) 10% difference in the circumference of the digit compared to the opposite digit and was then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present). The results from each digit with dactylitis were summed to produce a final score. For the final score, the minimum value for LDI is zero and there is no maximum value. A low score indicates less dactylitis symptoms. A score of zero is considered dactylitis free. Observed values have been reported in this outcome measure.	Baseline of PA0008, Week 48
Secondary	Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 Calculated Relative to Baseline of PA0008	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with psoriasis (PSO) for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. For the Final score, minimum possible PASI value is 0= no disease, maximum value is 72= maximal disease. Missing PASI responses were imputed using least observation carried forward (LOCF) for any visits where the corresponding BSA has not increased compared to the preceding visit.	Baseline of PA0008, Week 48
Secondary	Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 Calculated Relative to Baseline of PA0008	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. For the final score, minimum possible PASI value is 0= no disease, maximum value is 72= maximal disease. Missing PASI responses were imputed using LOCF for any visits where the corresponding BSA has not increased compared to the preceding visit.	Baseline of PA0008, Week 48