A Phase 3 interventional study of Placebo and Bimekizumab in Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, sponsored by UCB Biopharma SRL. Completed at 18 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by UCB Biopharma SRL · Phase 3, Interventional, and Treatment
The primary purpose of this study is to compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with moderate to severe plaque psoriasis (PSO).
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 133 is above 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.
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Exclusion Criteria:
Study participants randomized to this arm will receive bimekizumab (BKZ) dosage regimen 1 in the Initial Treatment Period (16 weeks) and switch to dosage regimen 2 and placebo to maintain the blinding in the Maintenance Treatment Period (16 weeks).
Other: Placebo · Drug: Bimekizumab
Study participants randomized to this arm will receive placebo comparator in the Initial Treatment Period (16 weeks) and switch to bimekizumab dosage regimen 1 in the Maintenance Treatment Period (16 weeks).
Other: Placebo · Drug: Bimekizumab
Study participants will receive placebo subcutaneously at pre-specified time points in the placebo arm as comparator and in the bimekizumab arm to maintain the blinding.
Study participants will receive bimekizumab (dosage regimen 1 and 2) subcutaneously administered at pre-specified time points during the Initial and Maintenance Treatment Periods.
Also known as: BKZ
Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16
PASI90:at least 90% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided in 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling (each on 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked). Determining percentage of skin covered with PSO for each body areas and converting to 0 to 6 scale (0=none; 1=1% to less than \[\<\] 10% affected; 2=10% to \<30% affected; 3=30% to \<50% affected; 4=50% to \<70% affected; 5=70% to \<90% affected; 6=90% to 100% affected). Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0=no disease, maximum score 72=maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place.
Time frame: Week 16
Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16
The IGA measured the overall psoriasis severity using a 5-point scale (0-4), where 0=clear - no signs of psoriasis; post-inflammatory hyperpigmentation may be present, 1=almost clear - no thickening; normal to pink coloration; no to minimal focal scaling, 2=mild - just detectable to mild thickening; pink to light red coloration and predominately fine scaling, 3=moderate - clearly distinguishable to moderate thickening; dull to bright red, moderate scaling and 4=severe - severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Percentage of Participants with Investigator´s Global Assessment (IGA) 0/1 response at Week 16 is reported here. The percentage of participants data was rounded to one decimal place.
Time frame: Week 16
Percentage of Participants With PASI75 Response at Week 4
PASI75 response: at least 75% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling on a 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Percentage of skin covered with PSO for each region was converted to 0 to 6 scale (0=none; 1=1% to \<10% affected; 2=10% to \<30% affected; 3=30% to \<50% affected; 4=50% to \<70% affected; 5=70% to \<90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0= no disease, the maximum PASI score 72= maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place.
Time frame: Week 4
Percentage of Participants With PASI100 Response at Week 16
PASI100: 100% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each region scored for redness, thickness, and scaling (each on a 5 point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Determining percentage of skin covered with PSO for each of body areas and 0 to 6 scale (0=none; 1=1% to \<10% affected; 2=10% to \<30% affected; 3=30% to \<50% affected; 4=50% to \<70% affected; 5=70% to \<90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score= 0 (no disease), the maximum PASI score= 72 (maximal disease). Higher score indicated increased disease severity. The percentage of participants data was rounded to one decimal place.
Time frame: Week 16
Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed 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. Each item was assessed for severity/impact level on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). PSD (P-SIM) response for itch at Week 16: participants were considered responders if itch score improved (decreased) by greater than or equal to (\>=) 4 points from Baseline to Week 16 and study participant had not discontinued the investigational medicinal product (IMP) prior to Week 16. Percentage of participants data was rounded to one decimal place.
Time frame: Week 16
Percentage of Participants With PSD P-SIM Response for Pain at Week 16
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed 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. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact. PSD (P-SIM) response for pain at Week 16: participants were considered responders if pain score improved (decreased) by \>=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place.
Time frame: Week 16
Percentage of Participants With PSD P-SIM Response for Scaling at Week 16
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed 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. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/impact) and 10 (very severe symptom/worst impact. PSD (P-SIM) response for scaling at Week 16: participants were considered responders if scaling score had improved (decreased) by \>=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place.
Time frame: Week 16
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 16
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place.
Time frame: From Baseline to End of Initial Treatment Period (up to Week 16)
Percentage of Participants With Serious TEAEs Through Week 16
A SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires in patient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above. The percentage of participants data was rounded to one decimal place.
Time frame: From Baseline to End of Initial Treatment Period (up to Week 16)
Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through Week 16
Percentage of Participants with TEAEs leading to permanent discontinuation of IMP through Week 16 was reported. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place.
Time frame: From Baseline to End of Initial Treatment Period (up to Week 16)
The study started to enroll participants in October 2023 and concluded in February 2025.
| Milestone | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 |
|---|---|---|
| Started | 33 | 100 |
| Completed | 30 | 97 |
| Not completed | 3 | 3 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Consent withdrawn by study participants (not due to adverse event) | 1 | 0 |
| Withdrew: Other (poor compliance, missed follow-up visit) | 0 | 1 |
| Withdrew: Other (risks outweighed the potential benefits) | 0 | 1 |
| Milestone | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 |
|---|---|---|
| Started | 30 | 96 |
| Completed | 30 | 89 |
| Not completed | 0 | 7 |
| Withdrew: Adverse event | 0 | 6 |
| Withdrew: Consent withdrawn by study participants (not due to adverse event) | 0 | 1 |
PASI90:at least 90% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided in 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling (each on 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked). Determining percentage of skin covered with PSO for each body areas and converting to 0 to 6 scale (0=none; 1=1% to less than \[\<\] 10% affected; 2=10% to \<30% affected; 3=30% to \<50% affected; 4=50% to \<70% affected; 5=70% to \<90% affected; 6=90% to 100% affected). Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0=no disease, maximum score 72=maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 | 3.0 | 94.0 |
The IGA measured the overall psoriasis severity using a 5-point scale (0-4), where 0=clear - no signs of psoriasis; post-inflammatory hyperpigmentation may be present, 1=almost clear - no thickening; normal to pink coloration; no to minimal focal scaling, 2=mild - just detectable to mild thickening; pink to light red coloration and predominately fine scaling, 3=moderate - clearly distinguishable to moderate thickening; dull to bright red, moderate scaling and 4=severe - severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Percentage of Participants with Investigator´s Global Assessment (IGA) 0/1 response at Week 16 is reported here. The percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16 | 3.0 | 92.0 |
PASI75 response: at least 75% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling on a 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Percentage of skin covered with PSO for each region was converted to 0 to 6 scale (0=none; 1=1% to \<10% affected; 2=10% to \<30% affected; 3=30% to \<50% affected; 4=50% to \<70% affected; 5=70% to \<90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0= no disease, the maximum PASI score 72= maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With PASI75 Response at Week 4 | 3.0 | 74.0 |
PASI100: 100% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each region scored for redness, thickness, and scaling (each on a 5 point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Determining percentage of skin covered with PSO for each of body areas and 0 to 6 scale (0=none; 1=1% to \<10% affected; 2=10% to \<30% affected; 3=30% to \<50% affected; 4=50% to \<70% affected; 5=70% to \<90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score= 0 (no disease), the maximum PASI score= 72 (maximal disease). Higher score indicated increased disease severity. The percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With PASI100 Response at Week 16 | 0 | 65.0 |
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed 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. Each item was assessed for severity/impact level on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). PSD (P-SIM) response for itch at Week 16: participants were considered responders if itch score improved (decreased) by greater than or equal to (\>=) 4 points from Baseline to Week 16 and study participant had not discontinued the investigational medicinal product (IMP) prior to Week 16. Percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16 | 8.0 | 84.1 |
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed 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. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact. PSD (P-SIM) response for pain at Week 16: participants were considered responders if pain score improved (decreased) by \>=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With PSD P-SIM Response for Pain at Week 16 | 14.3 | 86.1 |
The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed 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. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/impact) and 10 (very severe symptom/worst impact. PSD (P-SIM) response for scaling at Week 16: participants were considered responders if scaling score had improved (decreased) by \>=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With PSD P-SIM Response for Scaling at Week 16 | 20.0 | 91.6 |
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 16 | 51.5 | 62.0 |
A SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires in patient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above. The percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With Serious TEAEs Through Week 16 | 9.1 | 1.0 |
Percentage of Participants with TEAEs leading to permanent discontinuation of IMP through Week 16 was reported. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place.
| percentage of participants | ITP: Placebo | ITP: BKZ Dosage Regimen 1 |
|---|---|---|
| Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through Week 16 | 3.0 | 1.0 |
Collected over From Baseline through the final dose (Week 28) of IMP + 119 days (covering the 17-week SFU Visit, ie, up to 45 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ITP: Placebo | 0/33 (0%) | 3/33 (9.1%) | 7/33 (21.2%) |
| ITP: BKZ Dosage Regimen 1 | 0/100 (0%) | 1/100 (1%) | 31/100 (31%) |
| ITP+MTP: BKZ Dosage Regimen 1 | 0/130 (0%) | 4/130 (3.1%) | 37/130 (28.5%) |
| ITP+MTP: BKZ Dosage Regimen 2 | 0/96 (0%) | 4/96 (4.2%) | 20/96 (20.8%) |
| Event | ITP: Placebo | ITP: BKZ Dosage Regimen 1 | ITP+MTP: BKZ Dosage Regimen 1 | ITP+MTP: BKZ Dosage Regimen 2 |
|---|---|---|---|---|
| Femur fractureInjury, poisoning and procedural complications | 1/33 | 0/100 | 0/130 | 0/96 |
| Radius fractureInjury, poisoning and procedural complications | 1/33 | 0/100 | 0/130 | 0/96 |
| Ovarian cyst torsionReproductive system and breast disorders | 1/33 | 0/100 | 0/130 | 0/96 |
| Gastritis erosiveGastrointestinal disorders | 0/33 | 0/100 | 0/130 | 1/96 |
| IleusGastrointestinal disorders | 0/33 | 0/100 | 0/130 | 1/96 |
| Chemical poisoningInjury, poisoning and procedural complications | 0/33 | 0/100 | 0/130 | 1/96 |
| Adenocarcinoma of colonNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/33 | 0/100 | 0/130 | 1/96 |
| Tendon ruptureInjury, poisoning and procedural complications | 0/33 | 1/100 | 1/130 | 0/96 |
| Hypertrophic anal papillaGastrointestinal disorders | 0/33 | 0/100 | 1/130 | 0/96 |
| HaemorrhoidsGastrointestinal disorders | 0/33 | 0/100 | 1/130 | 0/96 |
| Event | ITP: Placebo | ITP: BKZ Dosage Regimen 1 | ITP+MTP: BKZ Dosage Regimen 1 | ITP+MTP: BKZ Dosage Regimen 2 |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 2/33 | 21/100 | 24/130 | 5/96 |
| Hepatic function abnormalHepatobiliary disorders | 0/33 | 3/100 | 3/130 | 7/96 |
| Aspartate aminotransferase increasedInvestigations | 2/33 | 3/100 | 4/130 | 1/96 |
| HyperlipidaemiaMetabolism and nutrition disorders | 2/33 | 5/100 | 5/130 | 1/96 |
| Injection site painGeneral disorders | 1/33 | 5/100 | 7/130 | 3/96 |
| Latent tuberculosisInfections and infestations | 0/33 | 0/100 | 0/130 | 5/96 |
| EczemaSkin and subcutaneous tissue disorders | 0/33 | 3/100 | 4/130 | 5/96 |
The Baseline refers the Randomized Set (RS) which consisted of all randomized study participants.
| Age, Continuous(years) | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 | Total |
|---|---|---|---|
| Mean | 39.9 ± 13.8 | 39.8 ± 13.2 | 39.8 ± 13.3 |
| Age, Customized(Participants) | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 | Total |
|---|---|---|---|
| 18 - <65 years | 32 | 96 | 128 |
| 65 - <85 years | 1 | 4 | 5 |
| >= 85 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 | Total |
|---|---|---|---|
| Female | 5 | 29 | 34 |
| Male | 28 | 71 | 99 |
| Race/Ethnicity, Customized(Participants) | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 | Total |
|---|---|---|---|
| Asian | 33 | 100 | 133 |
| Race/Ethnicity, Customized(Participants) | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 | Total |
|---|---|---|---|
| Not Hispanic or Latino | 33 | 100 | 133 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data from this study 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 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. This plan may change if a determination is made that the data cannot be adequately anonymized.
Supporting information: Study protocol, Sap, Csr
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