A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

• Bimekizumab (Drug), also known as UCB4940: Bimekizumab will be provided at pre-specified time intervals.
• Placebo (Other), also known as PBO: Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Primary outcomes

• Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 [At Week 16]: A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-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, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
• Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 [At Week 16]: The Investigator's Global Assessment (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 or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).

Secondary outcomes

• Percentage of Participants With a PASI100 Response at Week 16 [At Week 16]: A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-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, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
• Percentage of Participants With a IGA Clear Response at Week 16 [At Week 16]: The Investigator's Global Assessment (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 with at least >= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
• Percentage of Participants With a PASI75 Response at Week 4 [At Week 4]: A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-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, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders.
• Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16 [At Week 16]: As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.
• Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16 [At Week 16]: A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.
• Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16 [At Week 16]: As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.
• Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline [At Week 16]: Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.
• Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders [At Week 56]: A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI).
• Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period (up to Week 16)]: The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 adverse event (AE) being considered. If a participant had no events, the total time at risk was used.
• Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period (up to Week 16)]: The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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.
• Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period (up to Week 16)]: The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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.
• Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period [From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)]: The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 adverse event (AE) being considered. If a participant had no events, the total time at risk was used.
• Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period [From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)]: The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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.
• Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period [From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)]: The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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.
• Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment [From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)]: The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 adverse event (AE) being considered. If a participant had no events, the total time at risk was used.
• Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment [From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)]: The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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.
• Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment [From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)]: The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Must be at least 18 years of age
* Chronic plaque psoriasis (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 an active infection (except common cold), a recent 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 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

Participant flow

Outcome results

• Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Primary), Number, percentage of participants: Placebo (RS) 1.2; Bimekizumab 320 mg Q4W (RS) 90.8 (p <0.001)
• Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 (Primary), Number, percentage of participants: Placebo (RS) 1.2; Bimekizumab 320 mg Q4W (RS) 92.6 (p <0.001)
• Percentage of Participants With a PASI100 Response at Week 16 (Secondary), Number, percentage of participants: Placebo (RS) 1.2; Bimekizumab 320 mg Q4W (RS) 68.2 (p <0.001)
• Percentage of Participants With a IGA Clear Response at Week 16 (Secondary), Number, percentage of participants: Placebo (RS) 1.2; Bimekizumab 320 mg Q4W (RS) 69.6 (p <0.001)
• Percentage of Participants With a PASI75 Response at Week 4 (Secondary), Number, percentage of participants: Placebo (RS) 1.2; Bimekizumab 320 mg Q4W (RS) 75.9 (p <0.001)
• Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16 (Secondary), Number, percentage of participants: Placebo (RS) 9.0; Bimekizumab 320 mg Q4W (RS) 78.8 (p <0.001)
• Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16 (Secondary), Number, percentage of participants: Placebo (RS) 5.6; Bimekizumab 320 mg Q4W (RS) 75.5 (p <0.001)
• Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16 (Secondary), Number, percentage of participants: Placebo (RS) 5.7; Bimekizumab 320 mg Q4W (RS) 78.0 (p <0.001)
• Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline (Secondary), Number, percentage of participants: Placebo (RS) 6.8; Bimekizumab 320 mg Q4W (RS) 92.3 (p <0.001)
• Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders (Secondary), Number, percentage of participants: Bimekizumab 320 mg Q4W/Placebo (WK16ResS) 16.2; Bimekizumab 320 mg Q4W/Q8W (WK16ResS) 91.0; Bimekizumab 320 mg Q4W/Q4W (WK16ResS) 86.8; Bimekizumab 320 mg Q4W/Q8W+Q4W/Q4W (WK16ResS) 88.8 (p <0.001)
• Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period (Secondary), Number, no. of new events per 100 subject-years: Placebo (SS) 177.38 (123.55 to 246.69); Bimekizumab 320 mg Q4W (SS) 323.61 (281.60 to 370.11)
• Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period (Secondary), Number, no. of new events per 100 subject-years: Placebo (SS) 7.66 (0.93 to 27.68); Bimekizumab 320 mg Q4W (SS) 5.59 (2.05 to 12.17)
• Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period (Secondary), Number, no. of new events per 100 subject-years: Placebo (SS) 0 (NA to NA); Bimekizumab 320 mg Q4W (SS) 2.78 (0.57 to 8.12)
• Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period (Secondary), Number, no. of new events per 100 subject-years: Placebo/Placebo (WK16ResS) 144.37 (3.66 to 804.36); Bimekizumab 320 mg Q4W/Placebo (WK16ResS) 242.11 (189.44 to 304.90); Bimekizumab 320 mg Q4W/Q8W (WK16ResS) 224.87 (177.46 to 281.05); Bimekizumab 320 mg Q4W/Q4W (WK16ResS) 208.88 (165.11 to 260.69)
• Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period (Secondary), Number, no. of new events per 100 subject-years: Placebo/Placebo (WK16ResS) 0 (NA to NA); Bimekizumab 320 mg Q4W/Placebo (WK16ResS) 7.20 (1.96 to 18.43); Bimekizumab 320 mg Q4W/Q8W (WK16ResS) 4.04 (0.83 to 11.80); Bimekizumab 320 mg Q4W/Q4W (WK16ResS) 6.64 (2.16 to 15.50)
• Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period (Secondary), Number, no. of new events per 100 subject-years: Placebo/Placebo (WK16ResS) 0 (NA to NA); Bimekizumab 320 mg Q4W/Placebo (WK16ResS) 5.33 (1.10 to 15.58); Bimekizumab 320 mg Q4W/Q8W (WK16ResS) 2.69 (0.33 to 9.71); Bimekizumab 320 mg Q4W/Q4W (WK16ResS) 0 (NA to NA)
• Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment (Secondary), Number, no. of new events per 100 subject-years: Placebo Escape (ESS) 235.86 (164.29 to 328.03); Bimekizumab 320 mg Q4W Escape (ESS) 287.19 (143.36 to 513.86); Bimekizumab 320 mg Q4W/ Placebo Escape (ESS) 180.89 (115.90 to 269.15); Bimekizumab 320 mg Q4W/Q8W Escape (ESS) 491.37 (101.33 to 1435.98); Bimekizumab 320 mg Q4W/Q4W Escape (ESS) 349.52 (95.23 to 894.91)
• Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment (Secondary), Number, no. of new events per 100 subject-years: Placebo Escape (ESS) 5.24 (0.13 to 29.22); Bimekizumab 320 mg Q4W Escape (ESS) 0 (NA to NA); Bimekizumab 320 mg Q4W/ Placebo Escape (ESS) 0 (NA to NA); Bimekizumab 320 mg Q4W/Q8W Escape (ESS) 0 (NA to NA); Bimekizumab 320 mg Q4W/Q4W Escape (ESS) 0 (NA to NA)
• Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment (Secondary), Number, no. of new events per 100 subject-years: Placebo Escape (ESS) 0 (NA to NA); Bimekizumab 320 mg Q4W Escape (ESS) 18.77 (0.48 to 104.58); Bimekizumab 320 mg Q4W/ Placebo Escape (ESS) 0 (NA to NA); Bimekizumab 320 mg Q4W/Q8W Escape (ESS) 0 (NA to NA); Bimekizumab 320 mg Q4W/Q4W Escape (ESS) 0 (NA to NA)

Adverse events

Time frame: Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration)

Serious adverse events by term

Other adverse events by term

• Results publication: 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 Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185. PMID 35544084
• Results publication: 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 3 years of treatment in randomized phase III trials. Br J Dermatol. 2024 Mar 15;190(4):477-485. doi: 10.1093/bjd/ljad429. PMID 37950894
• Results publication: Strober B, Boehncke WH, Krueger JG, Magnolo N, Vender R, Warren RB, Lopez Pinto JM, Kavanagh S, Hoepken B, Gisondi P. Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3633-3650. doi: 10.1007/s13555-025-01557-1. Epub 2025 Oct 8. PMID 41060492
• Results publication: Armstrong A, Papp KA, Lebwohl M, Savage LJ, Yamanaka K, Vlase DE, Warham R, Lambert J, Lopez Pinto JM, Wixted K, Thaci D. Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT. Dermatol Ther (Heidelb). 2026 Jan;16(1):585-603. doi: 10.1007/s13555-025-01595-9. Epub 2025 Dec 8. PMID 41359217
• Results publication: Krueger JG, Cutcutache I, Lebwohl M, Gudjonsson JE, Pinter A, Langley RG, Merola J, Tada Y, Skelton A, Rastrick J, Ferecsko AS, Page M, Davies O, Lopez Pinto JM, Warham R, Shaw S, Warren RB. Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability. J Allergy Clin Immunol. 2026 Apr;157(4):905-916. doi: 10.1016/j.jaci.2025.12.1013. Epub 2026 Jan 22. PMID 41580158
• Results publication: Gisondi P, Elewski B, Pinter A, Yamaguchi Y, Gooderham M, Kavanagh S, Wixted K, Cross N, Szilagyi B, Merola JF. Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years. J Dermatolog Treat. 2026 Dec;37(1):2637344. doi: 10.1080/09546634.2026.2637344. Epub 2026 Mar 9. PMID 41800601
• Results publication: Blauvelt A, Langley RG, Lebwohl M, Strober B, Warren RB, Puig L, Morita A, Gordon KB, Fernandez-Penas P, Kavanagh S, Lopez Pinto JM, Lambert J, Hoepken B, Deherder D, Cross N, Thaci D. Bimekizumab durability of efficacy through 196 weeks and safety through 4 years in patients with moderate to severe plaque psoriasis: Results from the BE BRIGHT open-label extension trial. J Am Acad Dermatol. 2025 Sep;93(3):644-653. doi: 10.1016/j.jaad.2025.04.038. Epub 2025 Apr 24. PMID 40286813
• Results publication: Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22. PMID 39578348
• Results publication: Warren RB, Gottlieb AB, Merola JF, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Oct;11(5):1551-1569. doi: 10.1007/s13555-021-00570-4. Epub 2021 Jul 14. PMID 34260044
• Results publication: Gordon KB, Foley P, Krueger JG, Pinter A, Reich K, Vender R, Vanvoorden V, Madden C, White K, Cioffi C, Blauvelt A. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021 Feb 6;397(10273):475-486. doi: 10.1016/S0140-6736(21)00126-4. PMID 33549192

• Study Protocol (PDF, 2019-05-21)
• Statistical Analysis Plan (PDF, 2019-09-16)

• UCB Cares, Study director, 001 844 599 2273 (UCB)

NIH grants: 2016