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).

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

Chronic Plaque Psoriasis

Moderate to Severe Chronic Plaque Psoriasis

Placebo

Bimekizumab

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis

The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. 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.

The IGA measures 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. IGA response at week 16 is defined as a score of 0 or 1 with at least a two-category improvement from Baseline.

The PASI75 response at Week 4 is a key secondary endpoint. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. 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.

The PASI100 response at Week 16 is a key secondary endpoint. PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. 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

The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Itch response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD itch score.

The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Pain response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD pain score.

The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Scaling response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD scaling score.

An adverse event (AE) is 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. 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.

An SAE is any untoward medical occurrence that at any dose:
Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment with parenteral antibiotics 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

An adverse event (AE) is 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. 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 leading to withdrawal of study medication.

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).

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).

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

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