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 SURE  

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412747
• Other study ID #: PS0008
• Secondary ID: 2016-003392-22
• Status: Completed
• Phase: Phase 3
• Start date: January 26, 2018
• Est. completion date: February 26, 2020

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 compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: February 26, 2020
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be at least 18 years of age

• Chronic plaque PSO for at least 6 months prior to the Screening Visit

• 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 is a candidate for systemic PSO therapy and/or phototherapy

• Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

• Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab

• Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent 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

• Subject has had previous exposure to adalimumab

• Presence of active suicidal ideation or positive suicide behavior

• Presence of moderately severe major depression or severe major 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
• Adalimumab
Adalimumab will be administered according to the labeling recommendations.

Other:
• Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).

Locations

Country	Name	City	State
Australia	Ps0008 008	East Melbourne
Australia	Ps0008 004	Fremantle
Australia	Ps0008 007	Hectorville
Australia	Ps0008 010	Kogarah
Australia	Ps0008 005	Phillip
Australia	Ps0008 009	Woolloongabba
Canada	Ps0008 659	Calgary
Canada	Ps0008 663	Mississauga
Canada	Ps0008 660	Montréal
Canada	Ps0008 661	Peterborough
Canada	Ps0008 662	Toronto
Canada	Ps0008 664	Toronto
Canada	Ps0008 657	Waterloo
Canada	Ps0008 669	Windsor
Canada	Ps0008 670	Windsor
Canada	Ps0008 674	Winnipeg
Germany	Ps0008 207	Berlin
Germany	Ps0008 218	Bonn
Germany	Ps0008 203	Dresden
Germany	Ps0008 211	Hamburg
Germany	Ps0008 220	Hamburg
Germany	Ps0008 215	Lubeck
Germany	Ps0008 213	Mahlow
Germany	Ps0008 205	Osnabrück
Germany	Ps0008 217	Schweinfurt
Hungary	Ps0008 252	Budapest
Hungary	Ps0008 254	Budapest
Hungary	Ps0008 255	Budapest
Hungary	Ps0008 256	Debrecen
Hungary	Ps0008 251	Gyula
Hungary	Ps0008 260	Szeged
Korea, Republic of	Ps0008 702	Gwangju
Korea, Republic of	Ps0008 700	Seoul
Poland	Ps0008 355	Bialystok
Poland	Ps0008 362	Bialystok
Poland	Ps0008 371	Bydgoszcz
Poland	Ps0008 352	Gdansk
Poland	Ps0008 359	Katowice
Poland	Ps0008 366	Katowice
Poland	Ps0008 363	Kraków
Poland	Ps0008 360	Lódz
Poland	Ps0008 372	Lódz
Poland	Ps0008 356	Lublin
Poland	Ps0008 364	Nowa Sól
Poland	Ps0008 353	Szczecin
Poland	Ps0008 354	Warszawa
Poland	Ps0008 365	Wroclaw
Poland	Ps0008 367	Wroclaw
Poland	Ps0008 373	Wroclaw
Russian Federation	Ps0008 405	Saint Petersburg
Russian Federation	Ps0008 401	Saratov
Russian Federation	Ps0008 406	Yaroslavl
Taiwan	Ps0008 754	Taipei
Taiwan	Ps0008 755	Taipei
United States	Ps0008 940	Beverly	Massachusetts
United States	Ps0008 906	Boca Raton	Florida
United States	Ps0008 925	Brighton	Massachusetts
United States	Ps0008 931	Dallas	Texas
United States	Ps0008 939	Danbury	Connecticut
United States	Ps0008 908	East Windsor	New Jersey
United States	Ps0008 957	Glendale	Arizona
United States	Ps0008 945	Greer	South Carolina
United States	Ps0008 924	Houston	Texas
United States	Ps0008 951	Houston	Texas
United States	Ps0008 927	Los Angeles	California
United States	Ps0008 932	Oklahoma City	Oklahoma
United States	Ps0008 905	Overland Park	Kansas
United States	Ps0008 929	Portland	Oregon
United States	Ps0008 961	Rocky Mount	North Carolina
United States	Ps0008 955	San Diego	California
United States	Ps0008 943	San Luis Obispo	California
United States	Ps0008 967	Santa Monica	California
United States	Ps0008 936	Tampa	Florida
United States	Ps0008 917	Troy	Michigan
United States	Ps0008 934	Washington	District of Columbia
United States	Ps0008 900	West Des Moines	Iowa
United States	Ps0008 935	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Hungary,  Korea, Republic of,  Poland,  Russian Federation,  Taiwan, 

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	Percentage of Participants With a Psoriasis Area and Severity Index 90 (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 a 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 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
Primary	Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) 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
Secondary	Percentage of Participants With a PASI90 Response at Week 24	The PASI90 response assessments are based on at least 90% improvement in the 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 the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 24
Secondary	Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24	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] with at least a two-category improvement from Baseline at Week 24.	Week 24
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 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 4
Secondary	Percentage of Participants With a PASI100 Response at Week 16	The PASI100 response assessments are based on a 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	Percentage of Participants With a PASI100 Response at Week 24	The PASI100 response assessments are based on a 100% improvement in the 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 the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 24
Secondary	Percentage of Participants With a PASI90 Response at Week 56	PASI90 response assessments are based on at least 90% improvement in the 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/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/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 min possible PASI score is 0=no disease, max score is 72=maximal disease.	Week 56
Secondary	Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56	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]/almost clear [1] with at least a 2-category improvement from Baseline at Wk56.	Week 56
Secondary	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24	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 to Week 24
Secondary	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24	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 to Week 24
Secondary	Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24	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 to Week 24
Secondary	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)	The number of TEAEs 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 to Safety Follow-Up Visit (up to Week 72)
Secondary	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)	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 to Safety Follow-Up Visit (up to Week 72)
Secondary	Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)	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 to Safety Follow-Up Visit (up to Week 72)