NCT03536884: 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

Completed Phase 3 Results posted Last updated 15 April 2026

What this trial tests

Phase 3 trial testing Bimekizumab in Chronic Plaque Psoriasis in 743 participants. Completed in 9 August 2023.

Timeline

13 June 2018

Primary endpoint
12 September 2019

9 August 2023

Quick facts

Lead sponsor	UCB Biopharma SRL
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	743
Start date	13 June 2018
Primary completion	12 September 2019
Estimated completion	9 August 2023
Sites	77 locations across France, Netherlands, Belgium, United Kingdom, Germany, Poland, Canada, Australia

Drugs / interventions tested

• Bimekizumab (BIMEKIZUMAB) — full drug profile →
• Secukinumab (secukinumab) — full drug profile →
• Placebo

Conditions studied

• Chronic Plaque Psoriasis — all drugs for Chronic Plaque Psoriasis →
• Moderate to Severe Chronic Plaque Psoriasis — all drugs for Moderate to Severe Chronic Plaque Psoriasis →

Sponsor

UCB Biopharma SRL — full company profile →

Who can join

18 and older, any sex, with Chronic Plaque Psoriasis or Moderate to Severe Chronic Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 Primary · 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 weigh

Group	Value	95% CI
ITP: Bimekizumab (BKZ) 320 mg Q4W	61.7
ITP: Secukinumab 300 mg Q4W	48.9

Percentage of Participants With a PASI75 Response at Week 4 Secondary · 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 weight

Group	Value	95% CI
ITP: Bimekizumab (BKZ) 320 mg Q4W	71.0
ITP: Secukinumab 300 mg Q4W	47.3

Percentage of Participants With a PASI90 Response at Week 16 Secondary · 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 w

Group	Value	95% CI
ITP: Bimekizumab (BKZ) 320 mg Q4W	85.5
ITP: Secukinumab 300 mg Q4W	74.3

Percentage of Participants With a PASI100 Response at Week 48 Secondary · 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 weigh

Group	Value	95% CI
ITP+MTP: BKZ Q4W/Q4W +BKZ Q4W/Q8W	67.3
ITP+MTP: Secukinumab 300 mg Q4W/Q4W	46.2
MTP: BKZ 320 mg Q4W/Q8W	66.5
MTP: BKZ 320 mg Q4W/Q4W	73.5
MTP: Secukinumab 300 mg Q4W/Q4W	48.3

Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16 Secondary · 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 scalin

Group	Value	95% CI
ITP: Bimekizumab (BKZ) 320 mg Q4W	85.5
ITP: Secukinumab 300 mg Q4W	78.6

Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 Secondary · From Baseline up to Week 225

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.

Group	Value	95% CI
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)	250.13	213.09 – 291.75
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)	331.26	293.40 – 372.66
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)	234.88	209.22 – 262.83
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)	115.35	105.27 – 126.14
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)	165.22	143.73 – 189.02
OLE2 Period - Group A: BKZ 320 mg Q8W	164.95	66.32 – 339.86
OLE2 Period - Group B: BKZ 320 mg Q8W	74.25	51.72 – 103.26
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W	94.18	65.97 – 130.39

Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 Secondary · From Baseline up to Week 225

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.

Group	Value	95% CI
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)	6.94	3.17 – 13.17
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)	7.33	4.10 – 12.09
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)	6.75	4.23 – 10.22
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)	5.93	4.48 – 7.70
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)	4.34	2.16 – 7.76
OLE2 Period - Group A: BKZ 320 mg Q8W	12.28	0.31 – 68.43
OLE2 Period - Group B: BKZ 320 mg Q8W	1.38	0.03 – 7.66
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W	6.39	1.74 – 16.37

Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 Secondary · From Baseline up to Week 225

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.

Group	Value	95% CI
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)	1.51	0.18 – 5.45
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)	5.85	3.02 – 10.22
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)	3.33	1.66 – 5.96
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)	2.56	1.65 – 3.77
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)	3.52	1.61 – 6.69
OLE2 Period - Group A: BKZ 320 mg Q8W	11.33	0.29 – 63.10
OLE2 Period - Group B: BKZ 320 mg Q8W	2.76	0.33 – 9.99
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W	0	0 – 0

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ITP: BKZ 320 mg Q4W (up to Week 16)

Serious: 10/373 (3%)

Deaths: 0/373

ITP: Secukinumab 300 mg Q4W (up to Week 16)

Serious: 6/370 (2%)

Deaths: 0/370

MTP: BKZ 320 mg Q8W (Week 16 to Week 48)

Serious: 9/215 (4%)

Deaths: 1/215

ITP+MTP: BKZ 320 mg Q4W (up to Week 48)

Serious: 15/373 (4%)

Deaths: 0/373

ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)

Serious: 22/370 (6%)

Deaths: 2/370

OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)

Serious: 56/626 (9%)

Deaths: 3/626

OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)

Serious: 11/294 (4%)

Deaths: 1/294

OLE2 Period - Group A: BKZ 320 mg Q8W

Serious: 1/9 (11%)

Deaths: 0/9

OLE2 Period - Group B: BKZ 320 mg Q8W

Serious: 1/66 (2%)

Deaths: 0/66

OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W

Serious: 4/59 (7%)

Deaths: 1/59

Serious adverse events (118 terms)

Reaction	System	ITP: BKZ 320 mg Q4W (up to…	ITP: Secukinumab 300 mg Q4…	MTP: BKZ 320 mg Q8W (Week …	ITP+MTP: BKZ 320 mg Q4W (u…	ITP+MTP: Secukinumab 300 m…	OLE Period: BKZ 320 mg Q8W…	OLE Period: BKZ 320 mg Q4W…	OLE2 Period - Group A: BKZ…	OLE2 Period - Group B: BKZ…	OLE2 Period -Group B: BKZ …
Corona virus infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Erysipelas	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—
Colitis ulcerative	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Dengue fever	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Atypical pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Cervical vertebral fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Thoracic vertebral fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Pregnancy on oral contraceptive	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—	—	—	—	—
Suicide attempt	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Uterine polyp	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—

Other adverse events (20 terms — click to expand)

Reaction	System	ITP: BKZ 320 mg Q4W (up to…	ITP: Secukinumab 300 mg Q4…	MTP: BKZ 320 mg Q8W (Week …	ITP+MTP: BKZ 320 mg Q4W (u…	ITP+MTP: Secukinumab 300 m…	OLE Period: BKZ 320 mg Q8W…	OLE Period: BKZ 320 mg Q4W…	OLE2 Period - Group A: BKZ…	OLE2 Period - Group B: BKZ…	OLE2 Period -Group B: BKZ …
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Corona virus infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—	—	—	—	—	—	—
Intertrigo	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Macrocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Polycythaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—
Psychiatric evaluation abnormal	Investigations	—	—	—	—	—	—	—	—	—	—
White blood cell count increased	Investigations	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Prostatomegaly	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Corona virus infection, Osteoarthritis, Basal cell carcinoma, Atrial fibrillation, Appendicitis, Cardiac failure congestive, Erysipelas, Rotator cuff syndrome.

Data from ClinicalTrials.gov NCT03536884 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2020.
   Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
2. Bimekizumab versus Secukinumab in Plaque Psoriasis.
   Reich K, Warren RB, Lebwohl M, Gooderham M, et al · · 2021 · cited 283× · PMID 33891380 · DOI 10.1056/nejmoa2102383
3. Antibodies to watch in 2022.
   Kaplon H, Chenoweth A, Crescioli S, Reichert JM. · · 2022 · cited 245× · PMID 35030985 · DOI 10.1080/19420862.2021.2014296
4. Antibodies to watch in 2021.
   Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
5. Evolving understanding of autoimmune mechanisms and new therapeutic strategies of autoimmune disorders.
   Song Y, Li J, Wu Y. · · 2024 · cited 109× · PMID 39362875 · DOI 10.1038/s41392-024-01952-8
6. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2022 · cited 84× · PMID 35603936 · DOI 10.1002/14651858.cd011535.pub5
7. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Afach S, Doney L, et al · · 2020 · cited 78× · PMID 31917873 · DOI 10.1002/14651858.cd011535.pub3
8. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Guelimi R, Garcia-Doval I, et al · · 2023 · cited 67× · PMID 37436070 · DOI 10.1002/14651858.cd011535.pub6