BE RADIANT: 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

Sponsor

UCB Biopharma SRL (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03536884

Collaborator

(none)

743

Enrollment

Locations

Arms

61.4

Anticipated Duration (Months)

9.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

Condition or Disease	Intervention/Treatment	Phase
Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis	Drug: Bimekizumab Drug: Secukinumab Other: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

743 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 13, 2018

Actual Primary Completion Date :

Sep 12, 2019

Anticipated Study Completion Date :

Jul 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimekizumab dosage regimen 1 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 Subjects will receive bimekizumab at pre-specified time-points. Other Names: UCB4940 Other: Placebo Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period. Other Names: PBO
Experimental: Bimekizumab dosage regimen 2 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 Subjects will receive bimekizumab at pre-specified time-points. Other Names: UCB4940 Other: Placebo Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period. Other Names: PBO
Active Comparator: Secukinumab 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.	Drug: Bimekizumab Subjects will receive bimekizumab at pre-specified time-points. Other Names: UCB4940 Drug: Secukinumab Subjects will receive secukinumab at pre-specified time-points. Other Names: COSENTYX®

Arm

Intervention/Treatment

Experimental: Bimekizumab dosage regimen 1

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

Subjects will receive bimekizumab at pre-specified time-points.

Other Names:

UCB4940

Other: Placebo

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

Other Names:

PBO

Experimental: Bimekizumab dosage regimen 2

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

Subjects will receive bimekizumab at pre-specified time-points.

Other Names:

UCB4940

Other: Placebo

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

Other Names:

PBO

Active Comparator: Secukinumab

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.

Drug: Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

Other Names:

UCB4940

Drug: Secukinumab

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

Other Names:

COSENTYX®

Outcome Measures

Primary Outcome Measures

Psoriasis Area and Severity Index 100 (PASI100) response at Week 16 [Week 16]
A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.

Secondary Outcome Measures

PASI75 response at Week 4 [Week 4]
A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.
PASI90 response at Week 16 [Week 16]
A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.
PASI100 response at Week 48 [Week 48]
A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.
Investigator´s Global Assessment (IGA) response (0/1) at Week 16 [Week 16]
IGA response is defined as Clear (0) or Almost Clear (1) with at least a 2-category improvement relative to Baseline.
Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) [From Baseline to Safety Follow Up 2 (up to Week 216)]
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.
Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP [From Baseline to Safety Follow Up 2 (up to Week 216)]
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.
Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP [From Baseline to Safety Follow Up 2 (up to Week 216)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ps0015 975	Santa Ana	California	United States	92701
2	Ps0015 939	Danbury	Connecticut	United States	06810
3	Ps0015 903	Ocala	Florida	United States	34470
4	Ps0015 921	Ormond Beach	Florida	United States	32174
5	Ps0015 977	Pembroke Pines	Florida	United States	33028
6	Ps0015 936	Tampa	Florida	United States	33613
7	Ps0015 976	Tampa	Florida	United States	33614
8	Ps0015 970	West Palm Beach	Florida	United States	33409
9	Ps0015 966	Sandy Springs	Georgia	United States	30328
10	Ps0015 954	Skokie	Illinois	United States	60077
11	Ps0015 972	West Dundee	Illinois	United States	60118
12	Ps0015 900	West Des Moines	Iowa	United States	50265
13	Ps0015 944	New Orleans	Louisiana	United States	70115
14	Ps0015 915	Saint Louis	Missouri	United States	63117
15	Ps0015 953	Saint Louis	Missouri	United States	63141
16	Ps0015 901	Portsmouth	New Hampshire	United States	03801
17	Ps0015 965	Kew Gardens	New York	United States	11415
18	Ps0015 969	High Point	North Carolina	United States	27262
19	Ps0015 971	Wilmington	North Carolina	United States	28405
20	Ps0015 980	Bexley	Ohio	United States	43209
21	Ps0015 920	Portland	Oregon	United States	97210
22	Ps0015 929	Portland	Oregon	United States	97223
23	Ps0015 979	Dallas	Texas	United States	75246
24	Ps0015 924	Houston	Texas	United States	77004
25	Ps0015 978	Pflugerville	Texas	United States	78660
26	PS0015 3	Carlton		Australia
27	PS0015 7	Hectorville		Australia
28	PS0015 6	Kogarah		Australia
29	Ps0015 11	Parkville		Australia
30	PS0015 9	Woolloongabba		Australia
31	Ps0015 54	Brussels		Belgium
32	Ps0015 50	Bruxelles		Belgium
33	Ps0015 52	Liege		Belgium
34	Ps0015 673	Halifax		Canada
35	Ps0015 671	Hamilton		Canada
36	Ps0015 663	Mississauga		Canada
37	Ps0015 661	Peterborough		Canada
38	Ps0015 678	Richmond Hill		Canada
39	Ps0015 677	Toronto		Canada
40	Ps0015 657	Waterloo		Canada
41	Ps0015 153	Toulouse		France
42	Ps0015 223	Augsburg		Germany
43	Ps0015 237	Berlin		Germany
44	Ps0015 211	Hamburg		Germany
45	Ps0015 215	Lübeck		Germany
46	Ps0015 213	Mahlow		Germany
47	Ps0015 238	Mainz		Germany
48	Ps0015 234	München		Germany
49	Ps0015 219	Münster		Germany
50	Ps0015 236	Neu-ulm		Germany
51	Ps0015 222	Tuebingen		Germany
52	Ps0015 204	Witten		Germany
53	Ps0015 265	Amsterdam		Netherlands
54	Ps0015 263	Breda		Netherlands
55	Ps0015 355	Bialystok		Poland
56	Ps0015 361	Bialystok		Poland
57	Ps0015 369	Bialystok		Poland
58	Ps0015 352	Gdansk		Poland
59	Ps0015 366	Katowice		Poland
60	Ps0015 378	Katowice		Poland
61	Ps0015 376	Krakow		Poland
62	Ps0015 379	Krakow		Poland
63	Ps0015 372	Lodz		Poland
64	Ps0015 377	Ostrowiec Swietokrzyski		Poland
65	Ps0015 368	Wroclaw		Poland
66	Ps0015 375	Wroclaw		Poland
67	Ps0015 455	Alicante		Spain
68	Ps0015 450	Barcelona		Spain
69	Ps0015 451	Madrid		Spain
70	Ps0015 454	Madrid		Spain
71	Ps0015 456	Madrid		Spain
72	Ps0015 457	Sant Joan Despí		Spain
73	Ps0015 763	Gaziantep		Turkey
74	Ps0015 762	Istanbul		Turkey
75	Ps0015 760	Kayseri		Turkey
76	Ps0015 559	Newcastle Upon Tyne		United Kingdom
77	Ps0015 555	Salford		United Kingdom

Sponsors and Collaborators

UCB Biopharma SRL

Investigators

Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

UCB Biopharma SRL

ClinicalTrials.gov Identifier:

NCT03536884

Other Study ID Numbers:

PS0015
2017-003784-35

First Posted:

May 25, 2018

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by UCB Biopharma SRL

Bimekizumab

PSO

Psoriasis

Additional relevant MeSH terms:

Psoriasis

Study Results

No Results Posted as of Aug 24, 2022