A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Chronic Plaque Psoriasis Clinical Trial

— BE BRIGHT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598790
• Other study ID #: PS0014
• Secondary ID: 2016-003427-30
• Status: Completed
• Phase: Phase 3
• Start date: September 5, 2018
• Est. completion date: November 14, 2023

Study information

• Verified date: December 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1355
• Est. completion date: November 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Moderate to Severe Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.

Locations

Country	Name	City	State
Australia	PS0014 7	Campbelltown
Australia	PS0014 3	Carlton
Australia	PS0014 8	East Melbourne
Australia	PS0014 4	Fremantle
Australia	Ps0014 10	Kogarah
Australia	PS0014 6	Kogarah
Australia	PS0014 5	Phillip
Australia	PS0014 2	Westmead
Australia	PS0014 9	Woolloongabba
Belgium	Ps0014 50	Bruxelles
Belgium	Ps0014 51	Charleroi
Belgium	Ps0014 52	Liège
Canada	Ps0014 658	Ajax
Canada	Ps0014 659	Calgary
Canada	Ps0014 672	Edmonton
Canada	Ps0014 673	Halifax
Canada	Ps0014 671	Hamilton
Canada	Ps0014 675	Markham
Canada	Ps0014 663	Mississauga
Canada	Ps0014 660	Montreal
Canada	Ps0014 668	North Bay
Canada	Ps0014 652	Oakville
Canada	Ps0014 667	Ottawa
Canada	Ps0014 661	Peterborough
Canada	Ps0014 665	Quebec City
Canada	Ps0014 651	Richmond Hill
Canada	Ps0014 650	Surrey
Canada	Ps0014 676	Surrey
Canada	Ps0014 653	Toronto
Canada	Ps0014 662	Toronto
Canada	Ps0014 664	Toronto
Canada	Ps0014 657	Waterloo
Canada	Ps0014 669	Windsor
Canada	Ps0014 670	Windsor
Canada	Ps0014 674	Winnipeg
Germany	Ps0014 207	Berlin
Germany	Ps0014 218	Bonn
Germany	Ps0014 209	Darmstadt
Germany	Ps0014 203	Dresden
Germany	Ps0014 214	Erlangen
Germany	Ps0014 208	Frankfurt
Germany	Ps0014 210	Friedrichshafen
Germany	Ps0014 202	Hamburg
Germany	Ps0014 211	Hamburg
Germany	Ps0014 220	Hamburg
Germany	Ps0014 212	Heidelberg
Germany	Ps0014 215	Lübeck
Germany	Ps0014 213	Mahlow
Germany	Ps0014 219	Münster
Germany	Ps0014 205	Osnabrück
Germany	Ps0014 217	Schweinfurt
Germany	Ps0014 200	Schwerin
Germany	Ps0014 204	Witten
Hungary	Ps0014 252	Budapest
Hungary	Ps0014 254	Budapest
Hungary	Ps0014 255	Budapest
Hungary	Ps0014 261	Budapest
Hungary	Ps0014 256	Debrecen
Hungary	Ps0014 262	Encs
Hungary	Ps0014 251	Gyula
Hungary	Ps0014 253	Orosháza
Hungary	Ps0014 260	Szeged
Hungary	Ps0014 259	Szekszárd
Hungary	Ps0014 250	Szolnok
Hungary	Ps0014 258	Veszprém
Italy	Ps0014 300	Roma
Italy	Ps0014 303	Roma
Japan	Ps0014 629	Asahikawa
Japan	Ps0014 605	Bunkyo-ku
Japan	Ps0014 607	Chiyoda-ku
Japan	Ps0014 610	Chuo-ku
Japan	Ps0014 601	Fukuoka
Japan	Ps0014 619	Gifu
Japan	Ps0014 620	Hamamatsu
Japan	Ps0014 608	Itabashi-ku
Japan	Ps0014 609	Kobe
Japan	Ps0014 600	Kurume
Japan	Ps0014 622	Matsumoto
Japan	Ps0014 604	Minato-ku
Japan	Ps0014 623	Morioka
Japan	Ps0014 621	Nagoya
Japan	Ps0014 625	Nankoku
Japan	Ps0014 624	Obihiro
Japan	Ps0014 611	Osaka
Japan	Ps0014 614	Osaka
Japan	Ps0014 603	Sapporo
Japan	Ps0014 617	Sendai
Japan	Ps0014 613	Shimotsuke
Japan	Ps0014 602	Shinagawa-ku
Japan	Ps0014 612	Shinjuku-ku
Japan	Ps0014 618	Shinjuku-ku
Japan	Ps0014 626	Shinjuku-ku
Japan	Ps0014 628	Shinjuku-ku
Japan	Ps0014 606	Takaoka
Japan	Ps0014 615	Tokyo
Japan	Ps0014 627	Tokyo
Japan	Ps0014 616	TSU
Korea, Republic of	Ps0014 701	Busan
Korea, Republic of	Ps0014 702	Gwangju
Korea, Republic of	Ps0014 705	Seongnam-si
Korea, Republic of	Ps0014 700	Seoul
Korea, Republic of	Ps0014 703	Seoul
Poland	Ps0014 355	Bialystok
Poland	Ps0014 361	Bialystok
Poland	Ps0014 362	Bialystok
Poland	Ps0014 369	Bialystok
Poland	Ps0014 371	Bydgoszcz
Poland	Ps0014 352	Gdansk
Poland	Ps0014 358	Katowice
Poland	Ps0014 359	Katowice
Poland	Ps0014 366	Katowice
Poland	Ps0014 357	Kielce
Poland	Ps0014 363	Krakow
Poland	Ps0014 360	Lodz
Poland	Ps0014 372	Lodz
Poland	Ps0014 356	Lublin
Poland	Ps0014 364	Nowa Sol
Poland	Ps0014 374	Poznan
Poland	Ps0014 353	Szczecin
Poland	Ps0014 350	Warszawa
Poland	Ps0014 351	Warszawa
Poland	Ps0014 354	Warszawa
Poland	Ps0014 365	Wroclaw
Poland	Ps0014 367	Wroclaw
Poland	Ps0014 368	Wroclaw
Poland	Ps0014 370	Wroclaw
Poland	Ps0014 373	Wroclaw
Russian Federation	Ps0014 400	Moscow
Russian Federation	Ps0014 402	Moscow
Russian Federation	Ps0014 403	Moscow
Russian Federation	Ps0014 405	Saint Petersburg
Russian Federation	Ps0014 401	Saratov
Russian Federation	Ps0014 404	St. Petersburg
Russian Federation	Ps0014 406	Yaroslavl
Taiwan	Ps0014 754	Taipei
Taiwan	Ps0014 755	Taipei
United Kingdom	Ps0014 551	Dundee
United Kingdom	Ps0014 552	Liverpool
United Kingdom	Ps0014 550	Manchester
United Kingdom	Ps0014 554	Reading
United Kingdom	Ps0014 555	Salford
United States	Ps0014 941	Alpharetta	Georgia
United States	Ps0014 910	Bakersfield	California
United States	Ps0014 922	Baton Rouge	Louisiana
United States	Ps0014 940	Beverly	Massachusetts
United States	Ps0014 909	Boynton Beach	Florida
United States	Ps0014 925	Brighton	Massachusetts
United States	Ps0014 947	Buffalo	New York
United States	Ps0014 915	Clayton	Missouri
United States	Ps0014 912	Coral Gables	Florida
United States	Ps0014 931	Dallas	Texas
United States	Ps0014 908	East Windsor	New Jersey
United States	Ps0014 928	Fort Myers	Florida
United States	Ps0014 957	Glendale	Arizona
United States	Ps0014 945	Greer	South Carolina
United States	Ps0014 906	Hollywood	Florida
United States	Ps0014 924	Houston	Texas
United States	Ps0014 937	Johnston	Rhode Island
United States	Ps0014 965	Kew Gardens	New York
United States	Ps0014 927	Los Angeles	California
United States	Ps0014 907	Miami	Florida
United States	Ps0014 933	Murray	Utah
United States	Ps0014 944	New Orleans	Louisiana
United States	Ps0014 913	New York	New York
United States	Ps0014 903	Ocala	Florida
United States	Ps0014 932	Oklahoma City	Oklahoma
United States	Ps0014 958	Omaha	Nebraska
United States	Ps0014 921	Ormond Beach	Florida
United States	Ps0014 905	Overland Park	Kansas
United States	Ps0014 962	Owensboro	Kentucky
United States	Ps0014 946	Phoenix	Arizona
United States	Ps0014 911	Plainfield	Indiana
United States	Ps0014 920	Portland	Oregon
United States	Ps0014 929	Portland	Oregon
United States	Ps0014 901	Portsmouth	New Hampshire
United States	Ps0014 963	Rochester	New York
United States	Ps0014 961	Rocky Mount	North Carolina
United States	Ps0014 914	San Antonio	Texas
United States	Ps0014 919	San Diego	California
United States	Ps0014 955	San Diego	California
United States	Ps0014 943	San Luis Obispo	California
United States	Ps0014 967	Santa Monica	California
United States	Ps0014 954	Skokie	Illinois
United States	Ps0014 936	Tampa	Florida
United States	Ps0014 917	Troy	Michigan
United States	Ps0014 956	Verona	New Jersey
United States	Ps0014 934	Washington	District of Columbia
United States	Ps0014 951	Webster	Texas
United States	Ps0014 900	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Taiwan,  United Kingdom, 

References & Publications (3)

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 three years of treatment in randomized — View 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 Tr — View 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 B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP)	The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.	From Baseline to Safety Follow Up 2 (up to Week 220)
Secondary	Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP	The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.	From Baseline to Safety Follow Up 2 (up to Week 220)
Secondary	Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP	The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.	From Baseline to Safety Follow Up 2 (up to Week 220)
Secondary	Psoriasis Area Severity Index 90 (PASI90) response at Week 144	A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.	Week 144
Secondary	Investigator´s Global Assessment (IGA) 0/1 response at Week 144	The Investigator will assess the overall severity of psoriasis using the following 5-point scale (five-point IGA): 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); = Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); = Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); = Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); = Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions)	Week 144