This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.
Approximately 384 patients with moderate to severe plaque psoriasis will be enrolled and randomly assigned to one of the 2 treatment groups in a 1:1 ratio (192 patients in the Bmab 1200 group and 192 patients in the Stelara group). Patients who are diagnosed as moderate to severe chronic plaque psoriasis for at least 6 months and are candidate for systemic therapy or phototherapy at the time of the screening visit will be enrolled. The study is planned to be conducted in Europe and North America across approximately 48 sites in 5 countries. The study will be conducted in an outpatient setting, and the participation for each patient will consist of a screening period (up to 4 weeks/28 days) and a double-blind, active-controlled treatment period (52 weeks) with a rerandomization step for switching therapy (Bmab 1200 with Stelara ) before Week 16 dosing. The treatment period before the switch is TP1(Treatment Period1) and post switch is TP2(Treatment Period 2) (from Week 16 dosing to prior to Week 28 dosing) and TP3 (Treatment Period3)(from Week 28 dosing to Week 52). The total duration of the study (excluding the screening period) will be 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
384
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
Psoriasis Area and Severity Index (PASI)
Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12
Time frame: Baseline to Week 12
PASI Score
Percentage change from baseline in the PASI score at Baseline through Week 28. PASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage, plaque appearance, their response to therapy. 4 regions- head, upper limbs, trunk, and lower limbs are assessed separately for erythema, induration/thickness, and scaling. Degree of involvement is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement) for each region. Total score (sum of erythema, thickness, and scaling) is multiplied by the degree of involvement for each body region and then multiplied by constant. Sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the higher score indicating more severe disease. Change from baseline in PASI score indicates response to therapy. PASI 50 means ≥50% reduction from baseline in the PASI score
Time frame: Baseline through Week 28
PASI Improvement
PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75% relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Baseline through Week 28 and 52 PASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage, plaque appearance, their response to therapy. 4 regions- head, upper limbs, trunk, and lower limbs are assessed separately for erythema, induration/thickness, and scaling. Degree of involvement is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement) for each region. Total score (sum of erythema, thickness, and scaling) is multiplied by the degree of involvement for each body region and then multiplied by constant. Sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the higher score indicating more severe disease. Change from baseline in PASI score indicates response to therapy. PASI 50 means ≥50% reduction from baseline in the PASI score
Time frame: Baseline through Week 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Static Physician's Global Assessment (sPGA)
Change from Baseline in sPGA During TP2. The sPGA is a quantitative rating score of the patient's psoriasis based on physician's assessment at a given time point according to the following categories: induration, erythema, and scaling. The sPGA is a 6-point scale and patient's psoriasis is graded as clear (0), minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, erythema, and scaling will be divided by 3 to obtain a final sPGA score. lower score indicates better disease status
Time frame: Baseline through Week 28
Affected Body Surface Area
Change from baseline in affected body surface area at Weeks 28 Total % BSA afflicted by psoriasis is estimated using a handprint of the patient at each visit . The entire palmar surface of the patient's handprint is assumed to correspond to approximately 1% of total BSA. Reduction in BSA indicates improvement
Time frame: Baseline through Week 28
Dermatology Life Quality Index Scores
Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 28 It is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Nine of the 10 questions have response categories including "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3); Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Eight items also have a "Not relevant" option scored "0," which indicates no problems. Total scores range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a clinically important difference.
Time frame: Baseline through Week 28
Dermatology Life Quality Index Scores
Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 52 It is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Nine of the 10 questions have response categories including "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3); Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Eight items also have a "Not relevant" option scored "0," which indicates no problems. Total scores range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a clinically important difference.
Time frame: Baseline through Week 52
Static Physician's Global Assessment (sPGA)
Change in Static Physician's Global Assessment (sPGA) at Weeks 52 The sPGA is a quantitative rating score of the patient's psoriasis based on physician's assessment at a given time point according to the following categories: induration, erythema, and scaling. The sPGA is a 6-point scale and patient's psoriasis is graded as clear (0), minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, erythema, and scaling will be divided by 3 to obtain a final sPGA score. lower score indicates better disease status
Time frame: Baseline through Week 52
Affected Body Surface Area
Change from baseline in affected body surface area at Weeks 52 Total % BSA afflicted by psoriasis is estimated using a handprint of the patient at each visit . The entire palmar surface of the patient's handprint is assumed to correspond to approximately 1% of total BSA. Reduction in BSA indicates improvement
Time frame: Baseline through Week 52
PASI Improvement
PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75% relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Week 52
Time frame: Baseline through week 52
PASI Score
Percentage change from baseline in the PASI score at Baseline through Week 52. The PASI (Psoriasis Area and Severity Index) is a score from 0 to 72 that measures psoriasis severity based on lesion redness, thickness, scaling, and body area affected. The body is divided into four regions, each scored separately. Scores are calculated using severity and area involvement, and are used to assess treatment response (e.g., PASI 50 = 50% improvement).
Time frame: Baseline through Week 52