A Phase 3 interventional study of bimekizumab and Placebo in Moderate to Severe Plaque Psoriasis, sponsored by UCB Biopharma SRL. Completed at 9 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by UCB Biopharma SRL · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared with placebo.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 47 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study participants randomized to this arm will receive bimekizumab (BKZ; UCB4940) at pre-specified time points during the Treatment Period.
Drug: bimekizumab
Study participants randomized to this arm will receive placebo (PBO) at pre-specified time points during the Treatment Period.
Other: Placebo
Study participants will receive bimekizumab administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.
Also known as: BKZ, UCB4940
Study participants will receive placebo administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.
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 a 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 16
Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16
The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0/1 response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline.
Time frame: Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 16
Percentage of Participants With an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16
The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear \[0\] with at least a two-category improvement from Baseline.
Time frame: Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 4
Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16
The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including itch) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no itch)-10 (very severe itch)). Itch response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD itch weekly score.
Time frame: Week 16
Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16
The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point NRS where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including pain) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no pain)-10 (very severe pain)). Pain response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD pain weekly score.
Time frame: Week 16
Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Scaling at Week 16
The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including scaling) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no scaling)-10 (very severe scaling)). Scaling response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD scaling weekly score.
Time frame: Week 16
Percentage of Participants With Scalp IGA Response 0/1 (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) at Week 16 for Study Participants With Scalp Psoriasis (PSO) at Baseline
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 response 0/1 at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.
Time frame: Week 16
Percentage of Participants With Dermatology Life Quality Index (DLQI) 0/1 Response at Week 16
The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect study participants' health related quality of life (QOL). This instrument asks study participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in study participants with PSO. The DLQI total score ranges from 0 to 30, with higher scores indicating lower health related QOL. A 4-point change in the DLQI total score has been reported to be meaningful for the study participant (within-participant minimal important difference); while a DLQI total score of 0 or 1 indicates no impact of the skin disease on participant's life.
Time frame: Week 16
Percent Change From Baseline in Body Surface Area (BSA) Affected by PSO at Week 16
The Total BSA affected by PSO was entered as a percentage from 0 to 100.
Time frame: Baseline, Week 16
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk.
Time frame: From Baseline to End of Safety Follow-Up (SFU) (up to Week 32)
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Throughout the Study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Resulted in persistent disability/incapacity 5) Is a congenital anomaly or birth defect 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.
Time frame: From Baseline to End of Safety Follow-Up (up to Week 32)
Percentage of Participants With TEAEs Leading to Permanent Discontinuation of Investigational Medicinal Product (IMP) Throughout the Study
An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of IMP through the end of the time at risk.
Time frame: From Baseline to End of Safety Follow-Up (up to Week 32)
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 score ranges from 0 to 27 with higher scores indicating a worse state. A score of 5 to 9 is considered to be minimal symptoms of depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major depression. A score of 15 to 19 is considered to indicate moderately severe major depression, and a score ≥20 is considered to be severe major depression. Change from Baseline is derived as post-Baseline score minus Baseline score, where a positive change indicates worsening and a negative change indicates improvement.
Time frame: Baseline, Week 16
The study started to enroll study participants in September 2021 and concluded in September 2022.
| Milestone | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Started | 15 | 32 |
| Completed | 14 | 32 |
| Not completed | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
The PASI90 response assessments are based on a 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 | 0 | 81.3 |
The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0/1 response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16 | 0 | 87.5 |
The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 | 0 | 21.9 |
The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear \[0\] with at least a two-category improvement from Baseline.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16 | 0 | 21.9 |
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4 | 0 | 75.0 |
The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including itch) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no itch)-10 (very severe itch)). Itch response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD itch weekly score.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16 | 0 | 57.7 |
The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point NRS where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including pain) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no pain)-10 (very severe pain)). Pain response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD pain weekly score.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16 | 0 | 62.5 |
The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including scaling) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no scaling)-10 (very severe scaling)). Scaling response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD scaling weekly score.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Scaling at Week 16 | 0 | 64.3 |
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 response 0/1 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 | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With Scalp IGA Response 0/1 (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) at Week 16 for Study Participants With Scalp Psoriasis (PSO) at Baseline | 7.1 | 86.2 |
The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect study participants' health related quality of life (QOL). This instrument asks study participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in study participants with PSO. The DLQI total score ranges from 0 to 30, with higher scores indicating lower health related QOL. A 4-point change in the DLQI total score has been reported to be meaningful for the study participant (within-participant minimal important difference); while a DLQI total score of 0 or 1 indicates no impact of the skin disease on participant's life.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With Dermatology Life Quality Index (DLQI) 0/1 Response at Week 16 | 6.7 | 46.9 |
The Total BSA affected by PSO was entered as a percentage from 0 to 100.
| percent change | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percent Change From Baseline in Body Surface Area (BSA) Affected by PSO at Week 16 | -3.028 ± 8.926 | -83.472 ± 6.026 |
An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 40.0 | 50.0 |
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Resulted in persistent disability/incapacity 5) Is a congenital anomaly or birth defect 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Throughout the Study | 6.7 | 0 |
An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of IMP through the end of the time at risk.
| percentage of participants | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Percentage of Participants With TEAEs Leading to Permanent Discontinuation of Investigational Medicinal Product (IMP) Throughout the Study | 0 | 0 |
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 score ranges from 0 to 27 with higher scores indicating a worse state. A score of 5 to 9 is considered to be minimal symptoms of depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major depression. A score of 15 to 19 is considered to indicate moderately severe major depression, and a score ≥20 is considered to be severe major depression. Change from Baseline is derived as post-Baseline score minus Baseline score, where a positive change indicates worsening and a negative change indicates improvement.
| scores on a scale | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16 | -2.1 ± 5.1 | -2.4 ± 3.2 |
Collected over From Baseline to End of Safety Follow-Up (up to Week 32). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/15 (0%) | 1/15 (6.7%) | 6/15 (40%) |
| Bimekizumab 320 mg Q4W | 0/32 (0%) | 0/32 (0%) | 11/32 (34.4%) |
| Event | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Ankle fractureInjury, poisoning and procedural complications | 1/15 | 0/32 |
| Event | Placebo | Bimekizumab 320 mg Q4W |
|---|---|---|
| Corona virus infectionInfections and infestations | 1/15 | 7/32 |
| Oedema peripheralGeneral disorders | 1/15 | 0/32 |
| BacteriuriaInfections and infestations | 1/15 | 1/32 |
| Urinary tract infectionInfections and infestations | 1/15 | 0/32 |
| Blood creatinine increasedInvestigations | 1/15 | 0/32 |
| Psychiatric evaluation abnormalInvestigations | 1/15 | 0/32 |
| Back painMusculoskeletal and connective tissue disorders | 1/15 | 0/32 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/15 | 0/32 |
| Tinea pedisInfections and infestations | 0/15 | 2/32 |
| EczemaSkin and subcutaneous tissue disorders | 0/15 | 2/32 |
Baseline Characteristics refer to the Randomized Set which consisted of all randomized study participants.
| Age, Categorical(Participants) | Placebo | Bimekizumab 320 mg Q4W | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 32 | 47 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Placebo | Bimekizumab 320 mg Q4W | Total |
|---|---|---|---|
| Mean | 40.2 ± 11.3 | 39.7 ± 9.0 | 39.9 ± 9.7 |
| Sex: Female, Male(Participants) | Placebo | Bimekizumab 320 mg Q4W | Total |
|---|---|---|---|
| Female | 3 | 6 | 9 |
| Male | 12 | 26 | 38 |
| Race/Ethnicity, Customized(Participants) | Placebo | Bimekizumab 320 mg Q4W | Total |
|---|---|---|---|
| Asian | 15 | 32 | 47 |
| Race/Ethnicity, Customized(Participants) | Placebo | Bimekizumab 320 mg Q4W | Total |
|---|---|---|---|
| Not Hispanic or Latino | 15 | 32 | 47 |
Documents are hosted by the registry — open the source record to download them.
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, Sap, Csr
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