Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis (NCT NCT06011733)

The study started to enroll participants in October 2023 and concluded in February 2025.

Participant Flow refers to the Randomized Set.

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis

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.

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.

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.

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.

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.

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.

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.

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.

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 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.