A Phase 3 interventional study of Bimekizumab and Adalimumab in Chronic Plaque Psoriasis and Moderate to Severe Plaque Psoriasis, sponsored by UCB Biopharma SRL. Completed at 77 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 3, Interventional, and Treatment
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Among 20 studies testing bimekizumab in Psoriasis — 4 open to participants now, 5 under way, 3 of them phase 3. bimekizumab · Psoriasis.
Among the 20 studies testing bimekizumab in Psoriasis, this one is the 3rd largest by enrollment, is one of 4 that started in 2018, is one of 10 in phase 3, and was the 8th registered.
2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.
Browse Psoriasis studies →4 of the 20 studies testing bimekizumab in Psoriasis are open now, in 12 countries. Recruiting first, the newest first:
UCB Biopharma SRL · Sites in United States, Canada, China and 10 more countries
Ages 18+
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 18–45
University Hospital, Rouen · Sites in France
Ages 18–60
University of California, San Francisco · Sites in United States
Ages 18+
By country, each count listing its studies:
bimekizumab: first FDA approval 2023 (BIMZELX), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 478 is above the median of 75 across 1,567 interventional studies indexed under Psoriasis.
Median enrollment 161 across the 20 interventional studies. Of the 15 that completed or were terminated, 12 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 20 have an industry lead sponsor. The 8 most frequent:
This study is registered under UCB Biopharma SRL, one of the names counted as UCB S.A.. Under that name alone:
UCB Biopharma SRL is the lead sponsor of 130 studies on the registry; 18 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.
26 studies in Psoriasis by UCB S.A.: 1 open now, 2 under way, 2 of them phase 3. Of 24 finished, 19 (79%) have results posted.
Among the 26 studies in Psoriasis by UCB S.A., this one is the 5th largest by enrollment of the 25 interventional ones that give a count, is one of 5 that started in 2018, is one of 14 in phase 3, and was the 15th registered.
UCB S.A.’s Psoriasis studies by the year they started, since 2005.
None of the studies under way reaches primary completion within a year.
Among the 20 studies testing bimekizumab in Psoriasis, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among UCB S.A.’s 26 in Psoriasis:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Drug: Bimekizumab · Other: Placebo
Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Drug: Bimekizumab · Other: Placebo
Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Drug: Bimekizumab · Drug: Adalimumab · Other: Placebo
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Also known as: UCB4940
Adalimumab will be administered according to the labeling recommendations.
Also known as: Humira®
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Also known as: PBO
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.
Time frame: Week 16
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.
Time frame: Week 16
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.
Time frame: Week 24
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.
Time frame: Week 24
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.
Time frame: Week 4
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.
Time frame: Week 16
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.
Time frame: Week 24
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.
Time frame: Week 56
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.
Time frame: Week 56
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.
Time frame: From Baseline to Week 24
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.
Time frame: From Baseline to Week 24
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.
Time frame: From Baseline to Week 24
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.
Time frame: From Baseline to Safety Follow-Up Visit (up to Week 72)
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.
Time frame: From Baseline to Safety Follow-Up Visit (up to Week 72)
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.
Time frame: From Baseline to Safety Follow-Up Visit (up to Week 72)
The study started to enroll patients in January 2018 and concluded in February 2020.
| Milestone | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Bimekizumab 320 mg Q4W | Adalimumab |
|---|---|---|---|
| Started | 161 | 158 | 159 |
| Completed | 154 | 153 | 150 |
| Not completed | 7 | 5 | 9 |
| Withdrew: Adverse event | 2 | 2 | 3 |
| Withdrew: Death | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 4 | 1 | 1 |
| Withdrew: Participant moved out of state | 1 | 0 | 0 |
| Milestone | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Bimekizumab 320 mg Q4W | Adalimumab |
|---|---|---|---|
| Started | 154 | 153 | 150 |
| Completed | 149 | 152 | 149 |
| Not completed | 5 | 1 | 1 |
| Withdrew: Adverse event | 3 | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Milestone | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Bimekizumab 320 mg Q4W | Adalimumab |
|---|---|---|---|
| Started | 149 | 152 | 149 |
| Completed | 143 | 143 | 133 |
| Not completed | 6 | 9 | 16 |
| Withdrew: Adverse event | 3 | 4 | 6 |
| Withdrew: Lack of efficacy | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 | 5 |
| Withdrew: Withdrawal by subject | 3 | 1 | 4 |
| Withdrew: Moving out of town | 0 | 1 | 0 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | Adalimumab (RS) |
|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 | 86.2 | 47.2 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | Adalimumab (RS) |
|---|---|---|
| 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 | 85.3 | 57.2 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W/Q8W (RS) | Bimekizumab 320 mg Q4W (RS) | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | Adalimumab (RS) |
|---|---|---|---|---|
| Percentage of Participants With a PASI90 Response at Week 24 | 85.1 | 86.1 | 85.6 | 51.6 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W/Q8W (RS) | Bimekizumab 320 mg Q4W (RS) | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | Adalimumab (RS) |
|---|---|---|---|---|
| Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24 | 87.0 | 86.1 | 86.5 | 57.9 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | Adalimumab (RS) |
|---|---|---|
| Percentage of Participants With a PASI75 Response at Week 4 | 76.5 | 31.4 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | Adalimumab (RS) |
|---|---|---|
| Percentage of Participants With a PASI100 Response at Week 16 | 60.8 | 23.9 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W/Q8W (RS) | Bimekizumab 320 mg Q4W (RS) | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | Adalimumab (RS) |
|---|---|---|---|---|
| Percentage of Participants With a PASI100 Response at Week 24 | 65.8 | 67.7 | 66.8 | 29.6 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W/Q8W (RS) | Bimekizumab 320 mg Q4W (RS) |
|---|---|---|
| Percentage of Participants With a PASI90 Response at Week 56 | 82.6 | 84.8 |
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.
| percentage of participants | Bimekizumab 320 mg Q4W/Q8W (RS) | Bimekizumab 320 mg Q4W (RS) |
|---|---|---|
| Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56 | 83.2 | 82.3 |
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.
| no. of new events per 100 subject-years | Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) | Bimekizumab 320 mg Q4W Through Week 24 (SS) | Adalimumab Through Week 24 (SS) |
|---|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 310.44 (256.52 to 372.34) | 300.71 (247.60 to 361.83) | 297.54 (244.77 to 358.31) |
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.
| no. of new events per 100 subject-years | Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) | Bimekizumab 320 mg Q4W Through Week 24 (SS) | Adalimumab Through Week 24 (SS) |
|---|---|---|---|
| Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 1.37 (0.03 to 7.66) | 5.61 (1.53 to 14.38) | 6.98 (2.27 to 16.30) |
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.
| no. of new events per 100 subject-years | Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) | Bimekizumab 320 mg Q4W Through Week 24 (SS) | Adalimumab Through Week 24 (SS) |
|---|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 8.30 (3.05 to 18.07) | 4.16 (0.86 to 12.17) | 6.98 (2.27 to 16.29) |
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.
| no. of new events per 100 subject-years | Any Bimekizumab 320 mg Q8W (BKZ Set) | Any Bimekizumab 320 mg Q4W (BKZ Set) |
|---|---|---|
| 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) | 231.38 (191.68 to 276.88) | 262.41 (235.37 to 291.71) |
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.
| no. of new events per 100 subject-years | Any Bimekizumab 320 mg Q8W (BKZ Set) | Any Bimekizumab 320 mg Q4W (BKZ Set) |
|---|---|---|
| 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) | 7.03 (3.04 to 13.86) | 5.34 (3.05 to 8.67) |
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.
| no. of new events per 100 subject-years | Any Bimekizumab 320 mg Q8W (BKZ Set) | Any Bimekizumab 320 mg Q4W (BKZ Set) |
|---|---|---|
| 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) | 4.37 (1.42 to 10.19) | 4.62 (2.53 to 7.75) |
Collected over Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) | 0/161 (0%) | 1/161 (0.6%) | 65/161 (40.4%) |
| Bimekizumab 320 mg Q4W Through Week 24 (SS) | 0/158 (0%) | 4/158 (2.5%) | 61/158 (38.6%) |
| Adalimumab Through Week 24 (SS) | 1/159 (0.6%) | 5/159 (3.1%) | 62/159 (39%) |
| Any Bimekizumab 320 mg Q8W (BKZ Set) | 0/154 (0%) | 8/154 (5.2%) | 60/154 (39%) |
| Any Bimekizumab 320 mg Q4W (BKZ Set) | 0/468 (0%) | 16/468 (3.4%) | 182/468 (38.9%) |
| Event | Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) | Bimekizumab 320 mg Q4W Through Week 24 (SS) | Adalimumab Through Week 24 (SS) | Any Bimekizumab 320 mg Q8W (BKZ Set) | Any Bimekizumab 320 mg Q4W (BKZ Set) |
|---|---|---|---|---|---|
| Haemorrhagic anaemiaBlood and lymphatic system disorders | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| Duodenal ulcer haemorrhageGastrointestinal disorders | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| Umbilical herniaGastrointestinal disorders | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| Non-cardiac chest painGeneral disorders | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| AppendicitisInfections and infestations | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| ErysipelasSkin and subcutaneous tissue disorders | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| Hepatic enzyme increasedInvestigations | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| HypertensionVascular disorders | 0/161 | 0/158 | 0/159 | 1/154 | 0/468 |
| CellulitisInfections and infestations | 1/161 | 0/158 | 0/159 | 0/154 | 3/468 |
| Event | Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) | Bimekizumab 320 mg Q4W Through Week 24 (SS) | Adalimumab Through Week 24 (SS) | Any Bimekizumab 320 mg Q8W (BKZ Set) | Any Bimekizumab 320 mg Q4W (BKZ Set) |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 27/161 | 32/158 | 38/159 | 28/154 | 79/468 |
| Oral candidiasisInfections and infestations | 19/161 | 15/158 | 0/159 | 17/154 | 66/468 |
| Upper respiratory tract infectionInfections and infestations | 12/161 | 7/158 | 15/159 | 13/154 | 30/468 |
| HypertensionVascular disorders | 9/161 | 6/158 | 13/159 | 4/154 | 19/468 |
| PharyngitisInfections and infestations | 5/161 | 4/158 | 1/159 | 11/154 | 13/468 |
| DiarrhoeaGastrointestinal disorders | 5/161 | 8/158 | 4/159 | 5/154 | 14/468 |
Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.
| Age, Categorical(Participants) | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Bimekizumab 320 mg Q4W | Adalimumab | Total Title |
|---|---|---|---|---|
| <=18 years | 3 | 0 | 2 | 5 |
| Between 18 and 65 years | 145 | 147 | 137 | 429 |
| >=65 years | 13 | 11 | 20 | 44 |
| Age, Continuous(years) | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Bimekizumab 320 mg Q4W | Adalimumab | Total Title |
|---|---|---|---|---|
| Mean | 44.0 ± 13.5 | 45.3 ± 13.2 | 45.5 ± 14.3 | 44.9 ± 13.6 |
| Sex: Female, Male(Participants) | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Bimekizumab 320 mg Q4W | Adalimumab | Total Title |
|---|---|---|---|---|
| Female | 49 | 56 | 45 | 150 |
| Male | 112 | 102 | 114 | 328 |
| Race/Ethnicity, Customized(Participants) | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Bimekizumab 320 mg Q4W | Adalimumab | Total Title |
|---|---|---|---|---|
| Asian | 13 | 10 | 11 | 34 |
| Black or African American | 2 | 2 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 0 | 3 |
| White | 140 | 140 | 141 | 421 |
| Other/Mixed | 4 | 5 | 5 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data sharing details ↗ · www.vivli.org
Ran from Jan 2018 to primary completion in Feb 2019, 12 months.
Results were first posted in Mar 2022, 3 years after primary completion. A results delay was requested in Feb 2020.
Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 12 months is below that.
Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bimekizumab