Clinical trial NCT03598790: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Keywords: Bimekizumab
PSO
Psoriasis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 1353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).

Detailed description: The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.

Eligibility criteria: Inclusion Criteria:

Treatment Period (open-label)

* Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
* Subject completes the feeder study (PS0008 \[NCT03412747\], PS0009 \[NCT03370133\], PS0013 \[NCT03410992\]) without meeting any withdrawal criteria
* Female subjects must be:

  1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
  2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
  3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014

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:

Treatment Period (open-label)

* Subject has previously participated in this study
* Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
* Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator
* Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
* Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
* Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen

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

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)
timeFrame: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Secondary outcomes:
measure: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP
timeFrame: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
measure: Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP
timeFrame: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
measure: Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)
timeFrame: Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
measure: Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)
timeFrame: Week 144 compared to Baseline of PS0014 for Cohort B
measure: Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)
timeFrame: Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
measure: Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)
timeFrame: Week 144 for Cohort B EP and GPP groups
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Ps0014 957
state: Arizona
city: Phoenix
country: United States
facility: Ps0014 946
state: Arizona
city: Bakersfield
country: United States
facility: Ps0014 910
state: California
city: Los Angeles
country: United States
facility: Ps0014 927
state: California
city: San Diego
country: United States
facility: Ps0014 919
state: California
city: San Diego
country: United States
facility: Ps0014 955
state: California
city: San Luis Obispo
country: United States
facility: Ps0014 943
state: California
city: Santa Monica
country: United States
facility: Ps0014 967
state: California
city: Washington
country: United States
facility: Ps0014 934
state: District of Columbia
city: Boynton Beach
country: United States
facility: Ps0014 909
state: Florida
city: Coral Gables
country: United States
facility: Ps0014 912
state: Florida
city: Fort Myers
country: United States
facility: Ps0014 928
state: Florida
city: Hollywood
country: United States
facility: Ps0014 906
state: Florida
city: Miami
country: United States
facility: Ps0014 907
state: Florida
city: Ocala
country: United States
facility: Ps0014 903
state: Florida
city: Ormond Beach
country: United States
facility: Ps0014 921
state: Florida
city: Tampa
country: United States
facility: Ps0014 936
state: Florida
city: Alpharetta
country: United States
facility: Ps0014 941
state: Georgia
city: Skokie
country: United States
facility: Ps0014 954
state: Illinois
city: Plainfield
country: United States
facility: Ps0014 911
state: Indiana
city: West Des Moines
country: United States
facility: Ps0014 900
state: Iowa
city: Overland Park
country: United States
facility: Ps0014 905
state: Kansas
city: Owensboro
country: United States
facility: Ps0014 962
state: Kentucky
city: Baton Rouge
country: United States
facility: Ps0014 922
state: Louisiana
city: New Orleans
country: United States
facility: Ps0014 944
state: Louisiana
city: Beverly
country: United States
facility: Ps0014 940
state: Massachusetts
city: Brighton
country: United States
facility: Ps0014 925
state: Massachusetts
city: Troy
country: United States
facility: Ps0014 917
state: Michigan
city: Clayton
country: United States
facility: Ps0014 915
state: Missouri
city: Omaha
country: United States
facility: Ps0014 958
state: Nebraska
city: Portsmouth
country: United States
facility: Ps0014 901
state: New Hampshire
city: East Windsor
country: United States
facility: Ps0014 908
state: New Jersey
city: Verona
country: United States
facility: Ps0014 956
state: New Jersey
city: Buffalo
country: United States
facility: Ps0014 947
state: New York
city: Kew Gardens
country: United States
facility: Ps0014 965
state: New York
city: New York
country: United States
facility: Ps0014 913
state: New York
city: Rochester
country: United States
facility: Ps0014 963
state: New York
city: Rocky Mount
country: United States
facility: Ps0014 961
state: North Carolina
city: Oklahoma City
country: United States
facility: Ps0014 932
state: Oklahoma
city: Portland
country: United States
facility: Ps0014 920
state: Oregon
city: Portland
country: United States
facility: Ps0014 929
state: Oregon
city: Johnston
country: United States
facility: Ps0014 937
state: Rhode Island
city: Greer
country: United States
facility: Ps0014 945
state: South Carolina
city: Dallas
country: United States
facility: Ps0014 931
state: Texas
city: Houston
country: United States
facility: Ps0014 924
state: Texas
city: San Antonio
country: United States
facility: Ps0014 914
state: Texas
city: Webster
country: United States
facility: Ps0014 951
state: Texas
city: Murray
country: United States
facility: Ps0014 933
state: Utah
city: Campbelltown
country: Australia
facility: PS0014 7
city: Carlton
country: Australia
facility: PS0014 3
city: East Melbourne
country: Australia
facility: PS0014 8
city: Fremantle
country: Australia
facility: PS0014 4
city: Kogarah
country: Australia
facility: Ps0014 10
city: Kogarah
country: Australia
facility: PS0014 6
city: Phillip
country: Australia
facility: PS0014 5
city: Westmead
country: Australia
facility: PS0014 2
city: Woolloongabba
country: Australia
facility: PS0014 9
city: Bruxelles
country: Belgium
facility: Ps0014 50
city: Charleroi
country: Belgium
facility: Ps0014 51
city: Liège
country: Belgium
facility: Ps0014 52
city: Ajax
country: Canada
facility: Ps0014 658
city: Calgary
country: Canada
facility: Ps0014 659
city: Edmonton
country: Canada
facility: Ps0014 672
city: Halifax
country: Canada
facility: Ps0014 673
city: Hamilton
country: Canada
facility: Ps0014 671
city: Markham
country: Canada
facility: Ps0014 675
city: Mississauga
country: Canada
facility: Ps0014 663
city: Montreal
country: Canada
facility: Ps0014 660
city: North Bay
country: Canada
facility: Ps0014 668
city: Oakville
country: Canada
facility: Ps0014 652
city: Ottawa
country: Canada
facility: Ps0014 667
city: Peterborough
country: Canada
facility: Ps0014 661
city: Quebec City
country: Canada
facility: Ps0014 665
city: Richmond Hill
country: Canada
facility: Ps0014 651
city: Surrey
country: Canada
facility: Ps0014 650
city: Surrey
country: Canada
facility: Ps0014 676
city: Toronto
country: Canada
facility: Ps0014 653
city: Toronto
country: Canada
facility: Ps0014 662
city: Toronto
country: Canada
facility: Ps0014 664
city: Waterloo
country: Canada
facility: Ps0014 657
city: Windsor
country: Canada
facility: Ps0014 669
city: Windsor
country: Canada
facility: Ps0014 670
city: Winnipeg
country: Canada
facility: Ps0014 674
city: Berlin
country: Germany
facility: Ps0014 207
city: Bonn
country: Germany
facility: Ps0014 218
city: Darmstadt
country: Germany
facility: Ps0014 209
city: Dresden
country: Germany
facility: Ps0014 203
city: Erlangen
country: Germany
facility: Ps0014 214
city: Frankfurt
country: Germany
facility: Ps0014 208
city: Friedrichshafen
country: Germany
facility: Ps0014 210
city: Hamburg
country: Germany
facility: Ps0014 202
city: Hamburg
country: Germany
facility: Ps0014 211
city: Hamburg
country: Germany
facility: Ps0014 220
city: Heidelberg
country: Germany
facility: Ps0014 212
city: Lübeck
country: Germany
facility: Ps0014 215
city: Mahlow
country: Germany
facility: Ps0014 213
city: Münster
country: Germany
facility: Ps0014 219
city: Osnabrück
country: Germany
facility: Ps0014 205
city: Schweinfurt
country: Germany
facility: Ps0014 217
city: Schwerin
country: Germany
facility: Ps0014 200
city: Witten
country: Germany
facility: Ps0014 204
city: Budapest
country: Hungary
facility: Ps0014 252
city: Budapest
country: Hungary
facility: Ps0014 254
city: Budapest
country: Hungary
facility: Ps0014 255
city: Budapest
country: Hungary
facility: Ps0014 261
city: Debrecen
country: Hungary
facility: Ps0014 256
city: Encs
country: Hungary
facility: Ps0014 262
city: Gyula
country: Hungary
facility: Ps0014 251
city: Orosháza
country: Hungary
facility: Ps0014 253
city: Szeged
country: Hungary
facility: Ps0014 260
city: Szekszárd
country: Hungary
facility: Ps0014 259
city: Szolnok
country: Hungary
facility: Ps0014 250
city: Veszprém
country: Hungary
facility: Ps0014 258
city: Roma
country: Italy
facility: Ps0014 300
city: Roma
country: Italy
facility: Ps0014 303
city: Asahikawa
country: Japan
facility: Ps0014 629
city: Bunkyo-ku
country: Japan
facility: Ps0014 605
city: Chiyoda-ku
country: Japan
facility: Ps0014 607
city: Chuo-ku
country: Japan
facility: Ps0014 610
city: Fukuoka
country: Japan
facility: Ps0014 601
city: Gifu
country: Japan
facility: Ps0014 619
city: Hamamatsu
country: Japan
facility: Ps0014 620
city: Itabashi-ku
country: Japan
facility: Ps0014 608
city: Kobe
country: Japan
facility: Ps0014 609
city: Kurume
country: Japan
facility: Ps0014 600
city: Matsumoto
country: Japan
facility: Ps0014 622
city: Minato-ku
country: Japan
facility: Ps0014 604
city: Morioka
country: Japan
facility: Ps0014 623
city: Nagoya
country: Japan
facility: Ps0014 621
city: Nankoku
country: Japan
facility: Ps0014 625
city: Obihiro
country: Japan
facility: Ps0014 624
city: Osaka
country: Japan
facility: Ps0014 611
city: Osaka
country: Japan
facility: Ps0014 614
city: Sapporo
country: Japan
facility: Ps0014 603
city: Sendai
country: Japan
facility: Ps0014 617
city: Shimotsuke
country: Japan
facility: Ps0014 613
city: Shinagawa-ku
country: Japan
facility: Ps0014 602
city: Shinjuku-ku
country: Japan
facility: Ps0014 612
city: Shinjuku-ku
country: Japan
facility: Ps0014 618
city: Shinjuku-ku
country: Japan
facility: Ps0014 626
city: Shinjuku-ku
country: Japan
facility: Ps0014 628
city: Takaoka
country: Japan
facility: Ps0014 606
city: Tokyo
country: Japan
facility: Ps0014 615
city: Tokyo
country: Japan
facility: Ps0014 627
city: TSU
country: Japan
facility: Ps0014 616
city: Busan
country: Korea, Republic of
facility: Ps0014 701
city: Gwangju
country: Korea, Republic of
facility: Ps0014 702
city: Seongnam-si
country: Korea, Republic of
facility: Ps0014 705
city: Seoul
country: Korea, Republic of
facility: Ps0014 700
city: Seoul
country: Korea, Republic of
facility: Ps0014 703
city: Bialystok
country: Poland
facility: Ps0014 355
city: Bialystok
country: Poland
facility: Ps0014 361
city: Bialystok
country: Poland
facility: Ps0014 362
city: Bialystok
country: Poland
facility: Ps0014 369
city: Bydgoszcz
country: Poland
facility: Ps0014 371
city: Gdansk
country: Poland
facility: Ps0014 352
city: Katowice
country: Poland
facility: Ps0014 358
city: Katowice
country: Poland
facility: Ps0014 359
city: Katowice
country: Poland
facility: Ps0014 366
city: Kielce
country: Poland
facility: Ps0014 357
city: Krakow
country: Poland
facility: Ps0014 363
city: Lodz
country: Poland
facility: Ps0014 360
city: Lodz
country: Poland
facility: Ps0014 372
city: Lublin
country: Poland
facility: Ps0014 356
city: Nowa Sol
country: Poland
facility: Ps0014 364
city: Poznan
country: Poland
facility: Ps0014 374
city: Szczecin
country: Poland
facility: Ps0014 353
city: Warszawa
country: Poland
facility: Ps0014 350
city: Warszawa
country: Poland
facility: Ps0014 351
city: Warszawa
country: Poland
facility: Ps0014 354
city: Wroclaw
country: Poland
facility: Ps0014 365
city: Wroclaw
country: Poland
facility: Ps0014 367
city: Wroclaw
country: Poland
facility: Ps0014 368
city: Wroclaw
country: Poland
facility: Ps0014 370
city: Wroclaw
country: Poland
facility: Ps0014 373
city: Moscow
country: Russian Federation
facility: Ps0014 400
city: Moscow
country: Russian Federation
facility: Ps0014 402
city: Moscow
country: Russian Federation
facility: Ps0014 403
city: Saint Petersburg
country: Russian Federation
facility: Ps0014 405
city: Saratov
country: Russian Federation
facility: Ps0014 401
city: St. Petersburg
country: Russian Federation
facility: Ps0014 404
city: Yaroslavl
country: Russian Federation
facility: Ps0014 406
city: Taipei
country: Taiwan
facility: Ps0014 754
city: Taipei
country: Taiwan
facility: Ps0014 755
city: Dundee
country: United Kingdom
facility: Ps0014 551
city: Liverpool
country: United Kingdom
facility: Ps0014 552
city: Manchester
country: United Kingdom
facility: Ps0014 550
city: Reading
country: United Kingdom
facility: Ps0014 554
city: Salford
country: United Kingdom
facility: Ps0014 555
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
citation: Thaci D, Vender R, de Rie MA, Conrad C, Pariser DM, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball AB. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. Br J Dermatol. 2023 Jan 23;188(1):22-31. doi: 10.1093/bjd/ljac021.
citation: Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III trials. Br J Dermatol. 2024 Mar 15;190(4):477-485. doi: 10.1093/bjd/ljad429.
citation: 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.
citation: 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.