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

Chronic Plaque Psoriasis Clinical Trial

— BE RADIANT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536884
• Other study ID #: PS0015
• Secondary ID: 2017-003784-35
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2018
• Est. completion date: August 9, 2023

Study information

• Verified date: September 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 secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: August 9, 2023
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.
• Secukinumab
Subjects will receive secukinumab at pre-specified time-points.

Other:
• Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.

Locations

Country	Name	City	State
Australia	PS0015 3	Carlton
Australia	PS0015 7	Hectorville
Australia	PS0015 6	Kogarah
Australia	Ps0015 11	Parkville
Australia	PS0015 9	Woolloongabba
Belgium	Ps0015 54	Brussels
Belgium	Ps0015 50	Bruxelles
Belgium	Ps0015 52	Liege
Canada	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
France	Ps0015 153	Toulouse
Germany	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	Tuebingen
Germany	Ps0015 204	Witten
Netherlands	Ps0015 265	Amsterdam
Netherlands	Ps0015 263	Breda
Poland	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 Swietokrzyski
Poland	Ps0015 368	Wroclaw
Poland	Ps0015 375	Wroclaw
Spain	Ps0015 455	Alicante
Spain	Ps0015 450	Barcelona
Spain	Ps0015 451	Madrid
Spain	Ps0015 454	Madrid
Spain	Ps0015 456	Madrid
Spain	Ps0015 457	Sant Joan Despí
Turkey	Ps0015 763	Gaziantep
Turkey	Ps0015 762	Istanbul
Turkey	Ps0015 760	Kayseri
United Kingdom	Ps0015 559	Newcastle Upon Tyne
United Kingdom	Ps0015 555	Salford
United States	Ps0015 980	Bexley	Ohio
United States	Ps0015 915	Clayton	Missouri
United States	Ps0015 979	Dallas	Texas
United States	Ps0015 939	Danbury	Connecticut
United States	Ps0015 969	High Point	North Carolina
United States	Ps0015 924	Houston	Texas
United States	Ps0015 965	Kew Gardens	New York
United States	Ps0015 944	New Orleans	Louisiana
United States	Ps0015 903	Ocala	Florida
United States	Ps0015 921	Ormond Beach	Florida
United States	Ps0015 977	Pembroke Pines	Florida
United States	Ps0015 978	Pflugerville	Texas
United States	Ps0015 920	Portland	Oregon
United States	Ps0015 929	Portland	Oregon
United States	Ps0015 901	Portsmouth	New Hampshire
United States	Ps0015 953	Saint Louis	Missouri
United States	Ps0015 966	Sandy Springs	Georgia
United States	Ps0015 975	Santa Ana	California
United States	Ps0015 954	Skokie	Illinois
United States	Ps0015 936	Tampa	Florida
United States	Ps0015 976	Tampa	Florida
United States	Ps0015 900	West Des Moines	Iowa
United States	Ps0015 972	West Dundee	Illinois
United States	Ps0015 970	West Palm Beach	Florida
United States	Ps0015 971	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Netherlands,  Poland,  Spain,  Turkey,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 16
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.	Week 4
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.	Week 16
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.	Week 48
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.	Week 16
Secondary	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 48	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 48
Secondary	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48	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 48
Secondary	Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48	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 48

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