Moderate to Severe Chronic Plaque Psoriasis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALStelara
45 mg , 90 mg at Week 0, 4, 16, 28 and 40;During the study after receiving 2 doses , before dosing at Week 16 patients were re-randomised in a 1:1 ratio to receive either Bmab 1200 or Stelara .
BIOLOGICALBmab1200
45 mg , 90 mg at Week 0, 4, 16, 28 and 40
Sponsors
Biocon Biologics UK Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blinded (Patient, Investigator),
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is willing and able to provide informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion. 2. Patient is aged 18 to 80 years, both inclusive, and weighing \<130 kg at the time of the screening visit. 3. Patient has a diagnosis of chronic plaque psoriasis for at least 6 months and is a candidate for systemic therapy or phototherapy at the time of the screening visit. 4. Patient with moderate to severe chronic plaque psoriasis as defined by BSA (Body surface area)involvement * 10%, PASI score ≥12, and sPGA ≥3 at the screening and baseline visits. 5. Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion). 6. Patient has adequate renal and hepatic function at the screening 7. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline. A female patient is considered not of childbearing potential when postmenopausal or surgically sterilized 8. Women of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions.
Exclusion criteria
1. Patient has nonplaque psoriasis, such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), other current or chronic systemic autoimmune or inflammatory disease at the time of screening visit that would interfere with the evaluation of the effect of the study treatment on psoriasis. Patients with concurrent psoriatic arthritis will be allowed to participate. 2. Patient who has a current or past history of any of the following infections: 1. Current or past history of congenital or acquired immunodeficiency or patient is positive for the human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2) at screening. 2. Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as per serological tests at screening. * For HBV, patients who test positive to hepatitis B surface antigen (HBsAg) will be excluded. Patients who test positive to hepatitis B core antibody (HBcAb) only (HBsAg negative), may be enrolled if they also test positive to hepatitis B surface antibody (HBsAb). * For HCV, patient who test positive to HCV antibody will be excluded unless they test negative for HCV RNA. 3. Presence of active infection at screening or history of infection requiring intravenous antibiotics and/or hospitalization ≤8 weeks before baseline visit, or oral/intramuscular antibiotics ≤4 weeks before baseline visit, or topical antibiotics ≤2 weeks before baseline visit. Minor localized fungal infections or topical antibiotics for facial acne may be allowed. 4. Any recurrent bacterial, fungal, opportunistic or viral infection including recurrent/disseminated herpes zoster that, based on the investigator´s clinical assessment, causes a safety risk and makes the patient unsuitable for the study. 5. History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection. 3. Patient meeting any of the following tuberculosis (TB)-related conditions: 1. Patient who has current or history of active TB. 2. Patient who has signs or symptoms suggestive of active TB upon medical history or physical examination including chest radiography at screening. If a chest radiography performed within the past 3 months before screening is available, it does not need to be repeated at screening. 3. Patients with current latent TB (defined as a positive result of interferon-γ release assay \[IGRA\] with a negative examination of chest radiography \[posterior-anterior and lateral views, or per country regulations where applicable\] and absence of symptoms). Patients with positive IGRA (Interferon Gamma Release Assay) may be enrolled if they have documentation of completed appropriate country-specific TB prophylaxis within the past 5 years or have received at least 1 month of country-specific TB prophylaxis before the baseline visit and are willing to complete its entire course, and do not have other risk factors, radiologic findings, or physical evidence supporting latent or active TB. If a patient's initial IGRA test result is indeterminate, the test can be repeated once. If the test result is again indeterminate, the patient will be excluded from the study. 4. Patient who has had exposure to a person with active TB, such as first-degree family members or coworkers within 16 weeks before the baseline visit. 4. Patient has an underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic including central nervous system demyelinating disease, endocrine, cardiac, infection, or gastrointestinal) which, in the opinion of the investigator, significantly immune-compromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy. 5. Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period. 6. Patient who has prior exposure to more than 1 biologic agent for the treatment of psoriasis or psoriatic arthritis. 7. Patient who has received or plans to receive any of the prohibited medications or treatment that could affect psoriasis: 8. Patient has received a live or live-attenuated vaccine within 4 weeks before the baseline visit. Patient must agree not to receive a live or live-attenuated vaccine during the study and up to 15 weeks after the last dose of the study treatment. 9. Patient who has had Bacillus Calmette-Guérin (BCG) vaccination within 1 year before the baseline visit. Patients must agree not to receive a BCG vaccination during the study and at least 1 year after the last dose of the study treatment. 10. Have a transplanted organ/tissue or stem cell transplantation. 11. TP3 specific criteria: 1. Patient is willing and able to provide revised informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion 2. Patient has not developed any condition/ or met study discontinuation or treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) | Baseline to Week 12 | Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI Score | Baseline through Week 28 | 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 |
| PASI Improvement | Baseline through Week 28 | 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 |
| Static Physician's Global Assessment (sPGA) | Baseline through Week 28 | 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 |
| Affected Body Surface Area | Baseline through Week 28 | 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 |
| Dermatology Life Quality Index Scores | Baseline through Week 28 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Baseline to Week 52 | — |
| Safety:- Injection-site Reactions | Baseline through Week 28 and 52 | Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study |
| Safety:- Hypersensitivity | Baseline through Week 52 | Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study |
| Immunogenicity:-Developing Antidrug Antibodies | Baseline through Week 28 | Proportion of patients developing antidrug antibodies |
| Developing Neutralizing Antibodies | Baseline through Week 28 | Proportion of patients neutralizing antibodies |
| Pharmacokinetic:-Serum Concentrations | Postdosing on Week 28 | Serum concentrations of ustekinumab |
Countries
United States
Participant flow
Recruitment details
The study was conducted in Europe and North America and enrolled patients across 41 sites in 5 countries.
Participants by arm
| Arm | Count |
|---|---|
| Bmab1200 Bmab 1200 45 mg Bmab 1200 90 mg
Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40 | 191 |
| Stelara Stelara 45 mg Stelara 90 mg
Stelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara | 193 |
| Total | 384 |
Baseline characteristics
| Characteristic | Stelara | Total | Bmab1200 |
|---|---|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 13.58 | 43.2 years STANDARD_DEVIATION 13.34 | 42.5 years STANDARD_DEVIATION 13.09 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Subject | 0 Subject | 0 Subject |
| Race/Ethnicity, Customized Asian | 0 Subject | 0 Subject | 0 Subject |
| Race/Ethnicity, Customized Black or African American | 1 Subject | 2 Subject | 1 Subject |
| Race/Ethnicity, Customized Hispanic or Latino | 6 Subject | 12 Subject | 6 Subject |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Subject | 0 Subject | 0 Subject |
| Race/Ethnicity, Customized Not Hispanic or Latino | 187 Subject | 372 Subject | 185 Subject |
| Race/Ethnicity, Customized Other | 0 Subject | 0 Subject | 0 Subject |
| Race/Ethnicity, Customized White | 192 Subject | 382 Subject | 190 Subject |
| Region of Enrollment Europe | 189 Subject | 378 Subject | 189 Subject |
| Region of Enrollment United States | 4 Subject | 6 Subject | 2 Subject |
| Sex: Female, Male Female | 57 Participants | 127 Participants | 70 Participants |
| Sex: Female, Male Male | 136 Participants | 257 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 191 | 0 / 101 | 0 / 92 |
| other Total, other adverse events | 111 / 191 | 48 / 101 | 51 / 92 |
| serious Total, serious adverse events | 6 / 191 | 0 / 101 | 1 / 92 |
Outcome results
Primary
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
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Psoriasis Area and Severity Index (PASI) | -79.87 Percentage change from baseline | Standard Error 2.818 |
| Stelara | Psoriasis Area and Severity Index (PASI) | -80.55 Percentage change from baseline | Standard Error 2.783 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Affected Body Surface Area | -27.42 Change from Baseline in %BSA | Standard Deviation 15.119 |
| Stelara | Affected Body Surface Area | -26.50 Change from Baseline in %BSA | Standard Deviation 13.16 |
| Stelara-Bmab 1200 | Affected Body Surface Area | -28.90 Change from Baseline in %BSA | Standard Deviation 17.56 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Affected Body Surface Area | -26.52 Percentage of total body surface area | Standard Deviation 15.152 |
| Stelara | Affected Body Surface Area | -25.91 Percentage of total body surface area | Standard Deviation 13.323 |
| Stelara-Bmab 1200 | Affected Body Surface Area | -28.33 Percentage of total body surface area | Standard Deviation 17.251 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Dermatology Life Quality Index Scores | -12.2 score on a scale | Standard Deviation 6.84 |
| Stelara | Dermatology Life Quality Index Scores | -10.5 score on a scale | Standard Deviation 6.74 |
| Stelara-Bmab 1200 | Dermatology Life Quality Index Scores | -12.2 score on a scale | Standard Deviation 7.08 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Dermatology Life Quality Index Scores | -12.8 score on a scale | Standard Deviation 6.73 |
| Stelara | Dermatology Life Quality Index Scores | -11.5 score on a scale | Standard Deviation 6.35 |
| Stelara-Bmab 1200 | Dermatology Life Quality Index Scores | -12.7 score on a scale | Standard Deviation 6.98 |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bmab1200 | PASI Improvement | PASI 75 | 168 Participants |
| Bmab1200 | PASI Improvement | PASI 50 | 168 Participants |
| Bmab1200 | PASI Improvement | PASI 90 | 140 Participants |
| Stelara | PASI Improvement | PASI 75 | 79 Participants |
| Stelara | PASI Improvement | PASI 50 | 80 Participants |
| Stelara | PASI Improvement | PASI 90 | 70 Participants |
| Stelara-Bmab 1200 | PASI Improvement | PASI 50 | 84 Participants |
| Stelara-Bmab 1200 | PASI Improvement | PASI 90 | 67 Participants |
| Stelara-Bmab 1200 | PASI Improvement | PASI 75 | 83 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bmab1200 | PASI Improvement | PASI 75 | 159 Participants |
| Bmab1200 | PASI Improvement | PASI 50 | 163 Participants |
| Bmab1200 | PASI Improvement | PASI 90 | 133 Participants |
| Stelara | PASI Improvement | PASI 75 | 80 Participants |
| Stelara | PASI Improvement | PASI 50 | 80 Participants |
| Stelara | PASI Improvement | PASI 90 | 70 Participants |
| Stelara-Bmab 1200 | PASI Improvement | PASI 50 | 83 Participants |
| Stelara-Bmab 1200 | PASI Improvement | PASI 90 | 63 Participants |
| Stelara-Bmab 1200 | PASI Improvement | PASI 75 | 81 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | PASI Score | -95.50 Percentage change from Baseline | Standard Deviation 7.507 |
| Stelara | PASI Score | -96.60 Percentage change from Baseline | Standard Deviation 5.671 |
| Stelara-Bmab 1200 | PASI Score | -94.71 Percentage change from Baseline | Standard Deviation 7.95 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | PASI Score | -95.50 Percentage change from Baseline in Score | Standard Deviation 6.068 |
| Stelara | PASI Score | -96.01 Percentage change from Baseline in Score | Standard Deviation 6.461 |
| Stelara-Bmab 1200 | PASI Score | -95.44 Percentage change from Baseline in Score | Standard Deviation 7.321 |
Secondary
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
Population: sPGA-(averaged over all lesions); Score range: 0-5 Induration (I): 0 (no plaque-elevation) to 5 (severe plaque-elevation); Erythema (E): 0 (no erythema, hyperpigmentation maybe present) to 5 (dusky to deep-red coloration); Scaling (S): 0 (no scaling) to 5 (severe-very thick tenacious scale) sPGA based on Total-Average (I+E+S= /3): 0 (Cleared, except for residual discoloration) to 5 (Severe, majority of lesions have individual scores for I+E+S/3 that averages 5) Refer Apndx3-Protocol V3.0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Static Physician's Global Assessment (sPGA) | -3.1 score on a scale | Standard Deviation 1.21 |
| Stelara | Static Physician's Global Assessment (sPGA) | -3.0 score on a scale | Standard Deviation 1.29 |
| Stelara-Bmab 1200 | Static Physician's Global Assessment (sPGA) | -2.9 score on a scale | Standard Deviation 1.2 |
Secondary
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
Population: sPGA-(averaged over all lesions); Score range: 0-5 Induration (I): 0 (no plaque-elevation) to 5 (severe plaque-elevation); Erythema (E): 0 (no erythema, hyperpigmentation maybe present) to 5 (dusky to deep-red coloration); Scaling (S): 0 (no scaling) to 5 (severe-very thick tenacious scale) sPGA based on Total-Average (I+E+S= /3): 0 (Cleared, except for residual discoloration) to 5 (Severe, majority of lesions have individual scores for I+E+S/3 that averages 5) Refer Apndx3-Protocol V3.0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Static Physician's Global Assessment (sPGA) | -3.0 score on a scale | Standard Deviation 1.21 |
| Stelara | Static Physician's Global Assessment (sPGA) | -2.9 score on a scale | Standard Deviation 1.21 |
| Stelara-Bmab 1200 | Static Physician's Global Assessment (sPGA) | -2.8 score on a scale | Standard Deviation 1.28 |
Other Pre-specified
Developing Neutralizing Antibodies
Proportion of patients neutralizing antibodies
Time frame: Postdosing Week 52
Population: n = number of patients with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bmab1200 | Developing Neutralizing Antibodies | Nab reactive | 27 participants |
| Bmab1200 | Developing Neutralizing Antibodies | Nab negative | 104 participants |
| Stelara | Developing Neutralizing Antibodies | Nab reactive | 19 participants |
| Stelara | Developing Neutralizing Antibodies | Nab negative | 54 participants |
| Stelara-Bmab 1200 | Developing Neutralizing Antibodies | Nab reactive | 12 participants |
| Stelara-Bmab 1200 | Developing Neutralizing Antibodies | Nab negative | 62 participants |
Other Pre-specified
Developing Neutralizing Antibodies
Proportion of patients neutralizing antibodies
Time frame: Baseline through Week 28
Population: n = number of patients with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bmab1200 | Developing Neutralizing Antibodies | Nab reactive | 54 participants |
| Bmab1200 | Developing Neutralizing Antibodies | Nab negative | 108 participants |
| Stelara | Developing Neutralizing Antibodies | Nab reactive | 42 participants |
| Stelara | Developing Neutralizing Antibodies | Nab negative | 46 participants |
| Stelara-Bmab 1200 | Developing Neutralizing Antibodies | Nab reactive | 31 participants |
| Stelara-Bmab 1200 | Developing Neutralizing Antibodies | Nab negative | 55 participants |
Other Pre-specified
Immunogenicity:-Developing Antidrug Antibodies
Proportion of patients developing antidrug antibodies
Time frame: Postdosing Week 52
Population: n = number of patients with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bmab1200 | Immunogenicity:-Developing Antidrug Antibodies | ADA negative | 36 participants |
| Bmab1200 | Immunogenicity:-Developing Antidrug Antibodies | ADA positive | 131 participants |
| Bmab1200 | Immunogenicity:-Developing Antidrug Antibodies | Patients with no post baseline ADA result | 1 participants |
| Stelara | Immunogenicity:-Developing Antidrug Antibodies | ADA negative | 8 participants |
| Stelara | Immunogenicity:-Developing Antidrug Antibodies | ADA positive | 73 participants |
| Stelara | Immunogenicity:-Developing Antidrug Antibodies | Patients with no post baseline ADA result | 0 participants |
| Stelara-Bmab 1200 | Immunogenicity:-Developing Antidrug Antibodies | ADA positive | 74 participants |
| Stelara-Bmab 1200 | Immunogenicity:-Developing Antidrug Antibodies | Patients with no post baseline ADA result | 0 participants |
| Stelara-Bmab 1200 | Immunogenicity:-Developing Antidrug Antibodies | ADA negative | 10 participants |
Other Pre-specified
Immunogenicity:-Developing Antidrug Antibodies
Proportion of patients developing antidrug antibodies
Time frame: Baseline through Week 28
Population: n = number of patients with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bmab1200 | Immunogenicity:-Developing Antidrug Antibodies | ADA negative | 21 participants |
| Bmab1200 | Immunogenicity:-Developing Antidrug Antibodies | ADA positive | 162 participants |
| Bmab1200 | Immunogenicity:-Developing Antidrug Antibodies | Patients with no post baseline ADA result | 2 participants |
| Stelara | Immunogenicity:-Developing Antidrug Antibodies | ADA negative | 6 participants |
| Stelara | Immunogenicity:-Developing Antidrug Antibodies | ADA positive | 88 participants |
| Stelara | Immunogenicity:-Developing Antidrug Antibodies | Patients with no post baseline ADA result | 0 participants |
| Stelara-Bmab 1200 | Immunogenicity:-Developing Antidrug Antibodies | ADA positive | 86 participants |
| Stelara-Bmab 1200 | Immunogenicity:-Developing Antidrug Antibodies | Patients with no post baseline ADA result | 1 participants |
| Stelara-Bmab 1200 | Immunogenicity:-Developing Antidrug Antibodies | ADA negative | 5 participants |
Other Pre-specified
Pharmacokinetic:-Serum Concentrations
Serum concentrations of Ustekinumab
Time frame: Postdosing on Week 52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Pharmacokinetic:-Serum Concentrations | 728.029 ng/mL | Standard Deviation 477.1775 |
| Stelara | Pharmacokinetic:-Serum Concentrations | 665.403 ng/mL | Standard Deviation 379.9506 |
| Stelara-Bmab 1200 | Pharmacokinetic:-Serum Concentrations | 653.908 ng/mL | Standard Deviation 415.8309 |
| Bmab 1200 (2 Injection) | Pharmacokinetic:-Serum Concentrations | 881.343 ng/mL | Standard Deviation 510.0086 |
| Stelara-Stelara (2 Injection) | Pharmacokinetic:-Serum Concentrations | 1008.382 ng/mL | Standard Deviation 671.8667 |
| Stelara-Bmab 1200 ((2 Injection) | Pharmacokinetic:-Serum Concentrations | 898.450 ng/mL | Standard Deviation 551.4494 |
Other Pre-specified
Pharmacokinetic:-Serum Concentrations
Serum concentrations of ustekinumab
Time frame: Postdosing on Week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bmab1200 | Pharmacokinetic:-Serum Concentrations | 678.308 ng/mL | Standard Deviation 444.7791 |
| Stelara | Pharmacokinetic:-Serum Concentrations | 589.780 ng/mL | Standard Deviation 418.9308 |
| Stelara-Bmab 1200 | Pharmacokinetic:-Serum Concentrations | 620.793 ng/mL | Standard Deviation 398.1352 |
| Bmab 1200 (2 Injection) | Pharmacokinetic:-Serum Concentrations | 796.833 ng/mL | Standard Deviation 392.6448 |
| Stelara-Stelara (2 Injection) | Pharmacokinetic:-Serum Concentrations | 1070.600 ng/mL | Standard Deviation 522.0039 |
| Stelara-Bmab 1200 ((2 Injection) | Pharmacokinetic:-Serum Concentrations | 861.665 ng/mL | Standard Deviation 549.4014 |
Other Pre-specified
Safety:- Hypersensitivity
Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study
Time frame: Baseline through Week 52
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bmab1200 | Safety:- Hypersensitivity | 1 participants |
| Stelara | Safety:- Hypersensitivity | 3 participants |
| Stelara-Bmab 1200 | Safety:- Hypersensitivity | 1 participants |
Other Pre-specified
Safety:- Injection-site Reactions
Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study
Time frame: Baseline through Week 28 and 52
Population: NAb status with no injection site reactions being reported.
Other Pre-specified
Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period
Time frame: Baseline to Week 52
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bmab1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Squamous cell carcinoma of the tongue | 1 Participants |
| Bmab1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Abdominal pain | 1 Participants |
| Bmab1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Rash maculo-papular | 0 Participants |
| Bmab1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Endometrial adenocarcinoma | 1 Participants |
| Bmab1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Alcohol poisoning | 0 Participants |
| Bmab1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Jaundice cholestatic | 1 Participants |
| Bmab1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Angioedema | 0 Participants |
| Stelara | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Rash maculo-papular | 1 Participants |
| Stelara | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Endometrial adenocarcinoma | 0 Participants |
| Stelara | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Squamous cell carcinoma of the tongue | 0 Participants |
| Stelara | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Angioedema | 1 Participants |
| Stelara | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Abdominal pain | 0 Participants |
| Stelara | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Jaundice cholestatic | 0 Participants |
| Stelara | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Alcohol poisoning | 1 Participants |
| Stelara-Bmab 1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Abdominal pain | 0 Participants |
| Stelara-Bmab 1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Squamous cell carcinoma of the tongue | 0 Participants |
| Stelara-Bmab 1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Alcohol poisoning | 0 Participants |
| Stelara-Bmab 1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Jaundice cholestatic | 0 Participants |
| Stelara-Bmab 1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Rash maculo-papular | 0 Participants |
| Stelara-Bmab 1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Angioedema | 0 Participants |
| Stelara-Bmab 1200 | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Endometrial adenocarcinoma | 0 Participants |