A Study to Evaluate the Efficacy and Safety of Bimekizuma... | NCT03536884 | Trialant
NCT03536884
Sponsor
UCB Biopharma SRL
Status
Completed
Last Update Posted
Apr 15, 2026Actual
Enrollment
743Actual
Phase
Phase 3
Conditions
Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Interventions
Bimekizumab
Secukinumab
Placebo
Countries
United States
Australia
Belgium
Canada
France
Germany
Netherlands
Poland
Spain
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03536884
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PS0015
Secondary IDs
ID
Type
Description
Link
2017-003784-35
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official Title
A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym
BE RADIANT
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 13, 2018Actual
Primary Completion Date
Sep 12, 2019Actual
Completion Date
Aug 9, 2023Actual
First Submitted Date
May 14, 2018
First Submission Date that Met QC Criteria
May 14, 2018
First Posted Date
May 25, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 9, 2022
Results First Submitted that Met QC Criteria
Sep 9, 2022
Results First Posted Date
Oct 10, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 11, 2020
Certification/Extension First Submitted that Passed QC Review
Sep 11, 2020
Certification/Extension First Posted Date
Sep 14, 2020Actual
Last Update Submitted Date
Apr 2, 2026
Last Update Posted Date
Apr 15, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UCB Biopharma SRLINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).
Detailed Description
The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period for eligible subjects in the USA and Canada.
Conditions Module
Conditions
Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Keywords
Bimekizumab
PSO
Psoriasis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
743Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Bimekizumab dosage regimen 1
Experimental
Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1).
At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2).
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Drug: Bimekizumab
Other: Placebo
Bimekizumab dosage regimen 2
Experimental
Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks.
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Drug: Bimekizumab
Other: Placebo
Secukinumab
Active Comparator
Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2).
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bimekizumab
Drug
Subjects will receive bimekizumab at pre-specified time-points.
Bimekizumab dosage regimen 1
Bimekizumab dosage regimen 2
Secukinumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. 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 the percentage of skin covered with PSO for each of 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. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a PASI75 Response at Week 4
The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 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. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Double-blind Treatment Period
Male or female at least 18 years of age
Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
Subject must have Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5 point scale
Subject must be a candidate for systemic PSO therapy and/or phototherapy
Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
Female subject of childbearing potential must be willing to use highly effective method of contraception
Open-label extension (OLE) Period
Completed the double-blind Treatment Period without meeting any withdrawal criteria
All Week 48 visit assessments completed
Compliant with ongoing clinical study requirements
Signed a separate OLE Period Informed Consent Form (ICF)
Female subject of childbearing potential must be willing to use highly effective method of contraception
OLE2 Period (USA and Canada)
Completed the OLE Period without meeting any withdrawal criteria
Compliant with ongoing clinical study requirements
Female subject of childbearing potential must be willing to use highly effective method of contraception
Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
Signed a separate OLE2 Period ICF
Exclusion Criteria:
Double-blind Treatment Period
Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
Presence of active suicidal ideation or severe depression
Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
OLE2 Period (USA and Canada)
Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
Presence of active suicidal ideation or severe depression
Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez NN, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Participant flow refers to the Randomized Set (RS), Maintenance Set (MS), Open-Label Set (OLS), and Open-Label Set 2 (OLS2).
Recruitment Details
The study started to enroll participants in June 2018 and concluded in August 2023. Study has Screening Period (2-5 weeks (wk)), DB Treatment Period 48 wks (ITP-Wk 0-16 and MTP- Wk 16-Wk 48), an optional OLE Period (96 wks) followed by SFU Visit (20 wks after final dose) and an optional OLE2 Period followed by SFU2 Visit (20 wks after final dose).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W
Participants randomized to this arm received BKZ 320 mg subcutaneously (sc) every 4 weeks (Q4W) for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
Subjects will receive secukinumab at pre-specified time-points.
Secukinumab
COSENTYX®
Placebo
Other
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
Bimekizumab dosage regimen 1
Bimekizumab dosage regimen 2
PBO
Week 4
Percentage of Participants With a PASI90 Response at Week 16
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the 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 respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 16
Percentage of Participants With a PASI100 Response at Week 48
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. 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 the percentage of skin covered with PSO for each of 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. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 48
Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16
The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16.
Week 16
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to Week 225
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to Week 225
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to Week 225
Danbury
Connecticut
06810
United States
Ps0015 903
Ocala
Florida
34470
United States
Ps0015 921
Ormond Beach
Florida
32174
United States
Ps0015 977
Pembroke Pines
Florida
33028
United States
Ps0015 936
Tampa
Florida
33613
United States
Ps0015 976
Tampa
Florida
33614
United States
Ps0015 970
West Palm Beach
Florida
33409
United States
Ps0015 966
Sandy Springs
Georgia
30328
United States
Ps0015 954
Skokie
Illinois
60077
United States
Ps0015 972
West Dundee
Illinois
60118
United States
Ps0015 900
West Des Moines
Iowa
50265
United States
Ps0015 944
New Orleans
Louisiana
70115
United States
Ps0015 915
Clayton
Missouri
63105
United States
Ps0015 953
St Louis
Missouri
63141
United States
Ps0015 901
Portsmouth
New Hampshire
03801
United States
Ps0015 965
Kew Gardens
New York
11415
United States
Ps0015 969
High Point
North Carolina
27262
United States
Ps0015 971
Wilmington
North Carolina
28405
United States
Ps0015 980
Bexley
Ohio
43209
United States
Ps0015 920
Portland
Oregon
97210
United States
Ps0015 929
Portland
Oregon
97223
United States
Ps0015 979
Dallas
Texas
75246
United States
Ps0015 924
Houston
Texas
77004
United States
Ps0015 978
Pflugerville
Texas
78660
United States
PS0015 3
Carlton
Australia
PS0015 7
Hectorville
Australia
PS0015 6
Kogarah
Australia
Ps0015 11
Parkville
Australia
PS0015 9
Woolloongabba
Australia
Ps0015 50
Brussels
Belgium
Ps0015 54
Brussels
Belgium
Ps0015 52
Liège
Belgium
Ps0015 673
Halifax
Canada
Ps0015 671
Hamilton
Canada
Ps0015 663
Mississauga
Canada
Ps0015 661
Peterborough
Canada
Ps0015 678
Richmond Hill
Canada
Ps0015 677
Toronto
Canada
Ps0015 657
Waterloo
Canada
Ps0015 153
Toulouse
France
Ps0015 223
Augsburg
Germany
Ps0015 237
Berlin
Germany
Ps0015 211
Hamburg
Germany
Ps0015 215
Lübeck
Germany
Ps0015 213
Mahlow
Germany
Ps0015 238
Mainz
Germany
Ps0015 234
München
Germany
Ps0015 219
Münster
Germany
Ps0015 236
Neu-Ulm
Germany
Ps0015 222
Tübingen
Germany
Ps0015 204
Witten
Germany
Ps0015 265
Amsterdam
Netherlands
Ps0015 263
Breda
Netherlands
Ps0015 355
Bialystok
Poland
Ps0015 361
Bialystok
Poland
Ps0015 369
Bialystok
Poland
Ps0015 352
Gdansk
Poland
Ps0015 366
Katowice
Poland
Ps0015 378
Katowice
Poland
Ps0015 376
Krakow
Poland
Ps0015 379
Krakow
Poland
Ps0015 372
Lodz
Poland
Ps0015 377
Ostrowiec Świętokrzyski
Poland
Ps0015 368
Wroclaw
Poland
Ps0015 375
Wroclaw
Poland
Ps0015 455
Alicante
Spain
Ps0015 450
Barcelona
Spain
Ps0015 451
Madrid
Spain
Ps0015 454
Madrid
Spain
Ps0015 456
Madrid
Spain
Ps0015 457
Sant Joan DespÃ
Spain
Ps0015 763
Gaziantep
Turkey (Türkiye)
Ps0015 762
Istanbul
Turkey (Türkiye)
Ps0015 760
Kayseri
Turkey (Türkiye)
Ps0015 559
Newcastle upon Tyne
United Kingdom
Ps0015 555
Salford
United Kingdom
Result
Lebwohl M, Merola JF, Strober B, Armstrong A, Yoshizaki A, Gisondi P, Szilagyi B, Peterson L, de Cuyper D, Cross N, Davies O, Gottlieb AB. Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials. J Am Acad Dermatol. 2024 Aug;91(2):281-289. doi: 10.1016/j.jaad.2024.03.041. Epub 2024 Apr 6.
Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22.
Gisondi P, Elewski B, Pinter A, Yamaguchi Y, Gooderham M, Kavanagh S, Wixted K, Cross N, Szilagyi B, Merola JF. Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years. J Dermatolog Treat. 2026 Dec;37(1):2637344. doi: 10.1080/09546634.2026.2637344. Epub 2026 Mar 9.
Augustin M, Feldman SR, Warren RB, Armstrong A, Vender R, Lopez-Ferrer A, Dawe WH, Lambert J, Szilagyi B, Hoepken B, Warham R, Gottlieb AB. Three-Year Patient-Reported Outcomes From Bimekizumab for Plaque Psoriasis: The BE RADIANT Randomized Clinical Trial With Open-Label Extension. JAMA Dermatol. 2026 Apr 1;162(4):359-367. doi: 10.1001/jamadermatol.2025.6055.
Merola JF, Warren RB, Thaci D, Gordon KB, Nishida E, Strober B, Conrad C, Kavanagh S, Lopez Pinto JM, Hoepken B, Gisondi P. Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies. Am J Clin Dermatol. 2025 Nov;26(6):967-979. doi: 10.1007/s40257-025-00968-2. Epub 2025 Aug 31.
Warren RB, Lebwohl M, Thaci D, Gooderham M, Pinter A, Paul C, Gisondi P, Szilagyi B, White K, Deherder D, Staelens F, Lambert J, Strober B. Bimekizumab efficacy and safety through 3 years in patients with moderate-to-severe plaque psoriasis: long-term results from the BE RADIANT phase IIIb trial open-label extension period. Br J Dermatol. 2025 Jun 20;193(1):44-55. doi: 10.1093/bjd/ljaf032.
Augustin M, Gottlieb AB, Lebwohl M, Pinter A, Warren RB, Puig L, Warham R, Lambert J, Wiegratz S, Szilagyi B, Blauvelt A. Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2841-2857. doi: 10.1007/s13555-024-01261-6. Epub 2024 Sep 17.
Kokolakis G, Warren RB, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Korber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Nunez Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023 Feb 22;188(3):330-340. doi: 10.1093/bjd/ljac089.
Gottlieb AB, Warren RB, Augustin M, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.
Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805.
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
FG002
MTP: BKZ 320 mg Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
FG003
MTP: BKZ 320 mg Q4W/Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
FG004
MTP: Secukinumab 300 mg Q4W/Q4W
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
FG005
OLE Period: BKZ Week 0-48/BKZ Q8W 320 mg
Participants randomized to this arm received BKZ 320 mg sc Q4W for the first 16 weeks and then re-randomized to receive BKZ 320 mg sc Q4W or Q8W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response and the dose the participant was receiving at Week 48, participants were randomized to receive BKZ 320 mg sc Q8W until Week 136 in the Open-Label Extension (OLE) Period.
FG006
OLE Period: BKZ Week 0-48/ BKZ Q4W 320 mg
Participants randomized to this arm received BKZ 320 mg sc Q4W for the first 16 weeks and then re-randomized to receive BKZ 320 mg sc Q4W or Q8W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response and the dose the participant was receiving at Week 48, participants were randomized to receive BKZ 320 mg sc Q4W starting in OLE Period. The participant's dosing interval was changed from BKZ 320mg Q4W to BKZ 320mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64 after protocol amendment 5.
FG007
OLE Period: Secukinumab Week 0-48/ BKZ Q8W 320 mg
Participants randomized to this arm received Secukinumab 300 mg sc Q4W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response in double-blind Treatment Period, participants randomized to receive BKZ 320 mg sc Q8W until Week 136 of the OLE Period.
FG008
OLE Period: Secukinumab Week 0-48/ BKZ Q4W 320 mg
Participants randomized to this arm received Secukinumab 300 mg sc Q4W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response in double-blind Treatment Period, participants randomized to receive BKZ 320 mg sc Q4W starting in OLE Period. The participant's dosing interval was changed from BKZ 320mg Q4W to BKZ 320mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64 after protocol amendment 5.
FG009
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
FG010
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
FG011
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
FG000373 subjects
FG001370 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG000362 subjects
FG001354 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG00011 subjects
FG00116 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Unblinding was reason for dropout
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawn by Investigator for abnormal lab values
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Unable to attend visits
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Double-Blind Period: MTP Wk 16-48
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG002215 subjects
FG003147 subjects
FG004354 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG002205 subjects
FG003138 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00210 subjects
FG0039 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
OLE Period: Wk48-Wk144
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005238 subjectsParticipants who provided consent to continue in OLE Period.
FG00698 subjectsParticipants who provided consent to continue in OLE Period.
FG007122 subjectsParticipants who provided consent to continue in OLE Period.
FG008196 subjectsParticipants who provided consent to continue in OLE Period.
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0099 subjectsParticipants who provided consent to continue in OLE2 Period.
FG01066 subjectsParticipants who provided consent to continue in OLE2 Period.
FG01159 subjectsParticipants who provided consent to continue in OLE2 Period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W
Participants randomized to this arm received BKZ 320 mg subcutaneously (sc) every 4 weeks (Q4W) for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
BG001
ITP: Secukinumab 300 mg Q4W
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
BG002
Total Title
Denominators
Units
Counts
Participants
BG000373
BG001370
BG002743
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0003
BG0017
BG00210
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00045.9± 14.2
BG00144.0± 14.7
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000122
BG001135
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00019
BG00132
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. 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 the percentage of skin covered with PSO for each of 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. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
ITP: Bimekizumab (BKZ) 320 mg Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
OG001
ITP: Secukinumab 300 mg Q4W
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
Units
Counts
Participants
OG000373
OG001370
Title
Denominators
Categories
Title
Measurements
OG00061.7
OG00148.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Risk Difference: BKZ-Secukinumab calculated using stratified Cochran-Mantel-Haenszel (CMH).
Risk Difference (RD)
12.682
2-Sided
95
5.771
19.592
Non-Inferiority
The evaluation of noninferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a noninferiority margin of 10%.
Secondary
Percentage of Participants With a PASI75 Response at Week 4
The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 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. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
ITP: Bimekizumab (BKZ) 320 mg Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
OG001
ITP: Secukinumab 300 mg Q4W
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
Secondary
Percentage of Participants With a PASI90 Response at Week 16
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the 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 respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
ITP: Bimekizumab (BKZ) 320 mg Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
OG001
ITP: Secukinumab 300 mg Q4W
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
Secondary
Percentage of Participants With a PASI100 Response at Week 48
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. 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 the percentage of skin covered with PSO for each of 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. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
The Randomized Set (RS) consisted of all randomized study participants. The Maintenance Set (MS) consisted of all study participants that received at least 1 dose of IMP at Week 16 or later in the Double-Blind Treatment Period (including the Week 16 dose).
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
ITP+MTP: BKZ Q4W/Q4W +BKZ Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the ITP. At Week 16, participants either continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) or re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the MTP. Placebo was administered at pre-specified time-points to maintain the blinding.
OG001
ITP+MTP: Secukinumab 300 mg Q4W/Q4W
Secondary
Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16
The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16.
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
ITP: Bimekizumab (BKZ) 320 mg Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
OG001
ITP: Secukinumab 300 mg Q4W
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP. The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The Open-Label Set 2 (OLS2) consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline up to Week 225
ID
Title
Description
OG000
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)
Participants who received at least one dose of BKZ 320 mg sc Q8W from Week 16 until Week 48.
OG001
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)
Participants who received at least one dose of BKZ 320 mg sc Q4W until Week 48.
Secondary
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
The SS consisted of all study participants that received at least 1 dose of IMP. The OLS consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The OLS2 consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline up to Week 225
ID
Title
Description
OG000
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)
Participants who received at least one dose of BKZ 320 mg sc Q8W from Week 16 until Week 48.
OG001
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)
Participants who received at least one dose of BKZ 320 mg sc Q4W until Week 48.
OG002
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)
Secondary
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
The SS consisted of all study participants that received at least 1 dose of IMP. The OLS consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The OLS2 consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline up to Week 225
ID
Title
Description
OG000
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)
Participants who received at least one dose of BKZ 320 mg sc Q8W from Week 16 until Week 48.
OG001
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)
Participants who received at least one dose of BKZ 320 mg sc Q4W until Week 48.
OG002
Time Frame
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
Description
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ITP: BKZ 320 mg Q4W (up to Week 16)
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding.
0
373
10
373
107
373
EG001
ITP: Secukinumab 300 mg Q4W (up to Week 16)
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
0
370
6
370
88
370
EG002
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)
Participants who received at least one dose of BKZ 320 mg sc Q8W from Week 16 until Week 48.
1
215
9
215
87
215
EG003
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)
Participants who received at least one dose of BKZ 320 mg sc Q4W until Week 48.
0
373
15
373
140
373
EG004
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48.
2
370
22
370
166
370
EG005
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)
Participants received BKZ 320 mg sc Q8W from Week 48 until Week 136 during OLE Period. For participants that received both BKZ 320 mg Q4W and Q8W, events are counted in the dose group most recently received prior to the date of the event or assessment.
3
626
56
626
233
626
EG006
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)
Participants received BKZ 320 mg sc Q4W from Week 48 until Week 136 during OLE Period. The participant's dosing interval was changed from BKZ 320 mg Q4W to BKZ 320 mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64.
1
294
11
294
103
294
EG007
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48. Due to small number of participants, each event met the 5% threshold frequency criteria.
0
9
1
9
7
9
EG008
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
0
66
1
66
18
66
EG009
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
1
59
4
59
19
59
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Colitis ulcerative
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG0031 events1 affected373 at risk
EG0040 events0 affected370 at risk
EG0053 events1 affected626 at risk
EG0060 events0 affected294 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected66 at risk
EG0090 events0 affected59 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Dengue fever
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pregnancy on oral contraceptive
Pregnancy, puerperium and perinatal conditions
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Diverticulum oesophageal
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pancreatic fistula
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Appendicitis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0022 events2 affected215 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Peritoneal abscess
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Extradural abscess
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Localised infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pneumonia
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Urosepsis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Latent tuberculosis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
IIIrd nerve paralysis
Nervous system disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Otosclerosis
Ear and labyrinth disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Endocrine disorder
Endocrine disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Anal abscess
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Candida sepsis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Otitis externa
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Postoperative abscess
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Erysipelas
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Chondropathy
Musculoskeletal and connective tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Bladder cancer stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Hodgkin's disease nodular sclerosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Angiofibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Lentigo maligna
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Relapsing-remitting multiple sclerosis
Nervous system disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pregnancy on contraceptive
Pregnancy, puerperium and perinatal conditions
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Obstructive nephropathy
Renal and urinary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Erythrodermic psoriasis
Skin and subcutaneous tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Seizure
Nervous system disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Thromboangiitis obliterans
Vascular disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Macrocytosis
Blood and lymphatic system disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG0030 events0 affected373 at risk
EG0040 events0 affected370 at risk
EG0050 events0 affected626 at risk
EG0060 events0 affected294 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected66 at risk
EG0090 events0 affected59 at risk
Polycythaemia
Blood and lymphatic system disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Malaise
General disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG00054 events47 affected373 at risk
EG00161 events54 affected370 at risk
EG00240 events33 affected215 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG00041 events39 affected373 at risk
EG0014 events4 affected370 at risk
EG00247 events36 affected215 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG00016 events16 affected373 at risk
EG00117 events17 affected370 at risk
EG00225 events21 affected215 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0007 events6 affected373 at risk
EG0018 events7 affected370 at risk
EG00214 events10 affected215 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0002 events2 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0003 events3 affected373 at risk
EG0011 events1 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Blood pressure increased
Investigations
MedDRA19.0
Non-systematic Assessment
EG0005 events5 affected373 at risk
EG0011 events1 affected370 at risk
EG0021 events1 affected215 at risk
EG003
Psychiatric evaluation abnormal
Investigations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0021 events1 affected215 at risk
EG003
White blood cell count increased
Investigations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected373 at risk
EG0010 events0 affected370 at risk
EG0020 events0 affected215 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups are based on the CMH test for the general association.
Odds Ratio (OR)
1.714
2-Sided
95
1.271
2.310
Superiority
Units
Counts
Participants
OG000373
OG001370
Title
Denominators
Categories
Title
Measurements
OG00071.0
OG00147.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.
Odds Ratio (OR)
2.817
2-Sided
95
2.068
3.836
Superiority
Units
Counts
Participants
OG000373
OG001370
Title
Denominators
Categories
Title
Measurements
OG00085.5
OG00174.3
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the ITP. Participants continued to receive secukinumab 300 mg sc Q4W until Week 48 in the MTP.
OG002
MTP: BKZ 320 mg Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
OG003
MTP: BKZ 320 mg Q4W/Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
OG004
MTP: Secukinumab 300 mg Q4W/Q4W
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
Units
Counts
Participants
OG000373
OG001370
OG002215
OG003147
OG004354
Title
Denominators
Categories
Title
Measurements
OG00067.3
OG00146.2
OG00266.5
OG00373.5
OG00448.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.
Odds Ratio (OR)
2.490
2-Sided
95
1.835
3.377
Superiority
OG002
OG004
Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups are based on the CMH test from the general association.
Odds Ratio (OR)
2.168
2-Sided
95
1.511
3.110
Superiority
OG003
OG004
Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups are based on the CMH test from the general association.
Odds Ratio (OR)
3.243
2-Sided
95
2.103
5.000
Superiority
Units
Counts
Participants
OG000373
OG001370
Title
Denominators
Categories
Title
Measurements
OG00085.5
OG00178.6
OG002
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48.
OG003
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)
Participants received BKZ 320 mg sc Q8W from Week 48 until Week 136 during OLE Period. For participants that received both BKZ 320 mg Q4W and Q8W, events are counted in the dose group most recently received prior to the date of the event or assessment.
OG004
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)
Participants received BKZ 320 mg sc Q4W from Week 48 until Week 136 during OLE Period. The participant's dosing interval was changed from BKZ 320 mg Q4W to BKZ 320 mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64.
OG005
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
OG006
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
OG007
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
Units
Counts
Participants
OG000215
OG001373
OG002370
OG003626
OG004294
OG0059
OG00666
OG00759
Title
Denominators
Categories
Title
Measurements
OG000250.13(213.09 to 291.75)
OG001331.26(293.40 to 372.66)
OG002234.88(209.22 to 262.83)
OG003115.35(105.27 to 126.14)
OG004165.22(143.73 to 189.02)
OG005164.95(66.32 to 339.86)
OG00674.25(51.72 to 103.26)
OG00794.18(65.97 to 130.39)
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48.
OG003
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)
Participants received BKZ 320 mg sc Q8W from Week 48 until Week 136 during OLE Period. For subjects that received both BKZ 320mg Q4W and Q8W, events are counted in the dose group most recently received prior to the date of the event or assessment.
OG004
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)
Participants received BKZ 320 mg sc Q4W from Week 48 until Week 136 during OLE Period. The participant's dosing interval was changed from BKZ 320 mg Q4W to BKZ 320 mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64.
OG005
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
OG006
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
OG007
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
Units
Counts
Participants
OG000215
OG001373
OG002370
OG003626
OG004294
OG0059
OG00666
OG00759
Title
Denominators
Categories
Title
Measurements
OG0006.94(3.17 to 13.17)
OG0017.33(4.10 to 12.09)
OG0026.75(4.23 to 10.22)
OG0035.93(4.48 to 7.70)
OG0044.34(2.16 to 7.76)
OG00512.28(0.31 to 68.43)
OG0061.38(0.03 to 7.66)
OG0076.39(1.74 to 16.37)
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48.
OG003
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)
Participants received BKZ 320 mg sc Q8W from Week 48 until Week 136 during OLE Period. For subjects that received both BKZ 320mg Q4W and Q8W, events are counted in the dose group most recently received prior to the date of the event or assessment.
OG004
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)
Participants received BKZ 320 mg sc Q4W from Week 48 until Week 136 during OLE Period. The participant's dosing interval was changed from BKZ 320 mg Q4W to BKZ 320 mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64.
OG005
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
OG006
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
OG007
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.