Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Conditions
Keywords
Psoriasis, PSO, Bimekizumab, Chinese Adults Study Participants
Brief summary
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).
Interventions
OTHERPlacebo
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.
DRUGBimekizumab
Study participants will receive bimekizumab (dosage regimen 1 and 2) subcutaneously administered at pre-specified time points during the Initial and Maintenance Treatment Periods.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Study participant is Chinese male or female ≥18 years of age * Study participant has plaque psoriasis (PSO) for ≥6 months prior to the Screening Visit * Study participant has Psoriasis Area and Severity Index (PASI) ≥12 and body surface area (BSA) affected by PSO ≥10% and Investigator's Global Assessment (IGA) score ≥3 on a 5-point scale. * Study participant is a candidate for systemic PSO therapy and/or phototherapy * Female study participants must be postmenopausal or permanently sterilized or if childbearing potential must be willing to use protocol defined highly effective method of contraception throughout the duration of the study until 17 weeks after last administration of investigational medicinal product (IMP) and have a negative pregnancy test at Screening and prior to first dose
Exclusion criteria
* Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 17 weeks following the final dose of IMP * Study participant has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic, guttate, or drug-induced PSO) * Study participant has an active infection or history of infection(s) as defined in the protocol * Study participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.Study participant has a past history of active TB involving any organ system unless adequately treated and is proven to be fully recovered upon consult with a TB specialist * Study participant has a diagnosis of inflammatory conditions other than PSO vulgaris or psoriatic arthritis (PsA) * Study participant has presence of significant uncontrolled neuropsychiatric disorder. Study participants with history of suicide attempt within the 5 years prior to the Screening Visit must be excluded. Study participants with history of suicide attempt more than 5 years prior to the Screening Visit must be evaluated by a mental health care practitioner before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 | 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. |
| Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With PASI75 Response at Week 4 | 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. |
| Percentage of Participants With PASI100 Response at Week 16 | 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. |
| Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16 | 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. |
| Percentage of Participants With PSD P-SIM Response for Pain at Week 16 | 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. |
| Percentage of Participants With PSD P-SIM Response for Scaling at Week 16 | 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. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 16 | From Baseline to End of Initial Treatment Period (up to 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. |
| Percentage of Participants With Serious TEAEs Through Week 16 | From Baseline to End of Initial Treatment Period (up to 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. |
| Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through Week 16 | 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 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. |
Countries
China
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273
Participant flow
Recruitment details
The study started to enroll participants in October 2023 and concluded in February 2025.
Pre-assignment details
Participant Flow refers to the Randomized Set.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 13.3 |
| Age, Customized 18 - <65 years | 128 Participants |
| Age, Customized 65 - <85 years | 5 Participants |
| Age, Customized >= 85 years | 0 Participants |
| Race/Ethnicity, Customized Asian | 33 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 100 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 100 | 0 / 130 | 0 / 96 |
| other Total, other adverse events | 7 / 33 | 31 / 100 | 37 / 130 | 20 / 96 |
| serious Total, serious adverse events | 3 / 33 | 1 / 100 | 4 / 130 | 4 / 96 |
Outcome results
None listed