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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bmab1200 | Experimental | Bmab 1200 45 mg Bmab 1200 90 mg |
|
| Stelara | Active Comparator | Stelara 45 mg Stelara 90 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stelara | Biological | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) | Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12 | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study |
Inclusion Criteria:
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.
Patient is aged 18 to 80 years, both inclusive, and weighing <130 kg at the time of the screening visit.
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.
Patient with moderate to severe chronic plaque psoriasis as defined by BSA (Body surface area)involvement
Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion).
Patient has adequate renal and hepatic function at the screening
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
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:
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.
Patient who has a current or past history of any of the following infections:
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.
Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as per serological tests at screening.
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.
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.
History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection.
Patient meeting any of the following tuberculosis (TB)-related conditions:
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.
Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period.
Patient who has prior exposure to more than 1 biologic agent for the treatment of psoriasis or psoriatic arthritis.
Patient who has received or plans to receive any of the prohibited medications or treatment that could affect psoriasis:
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.
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.
Have a transplanted organ/tissue or stem cell transplantation.
TP3 specific criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apex Clinical Research Center | Mayfield Heights | Ohio | 44124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41100115 | Derived | Szepietowski JC, Reich A, Feldman SR, Pulka G, Mekokishvili L, Tsiskarishvili N, Svarca I, Poder A, Singh G, Deodhar S, Kumar K, Marwah A, Loganathan S, Wolff-Holz E, Athalye SN. Comparative efficacy and safety of biosimilar Bmab 1200 versus reference ustekinumab in moderate-to-severe plaque psoriasis: 52-week findings from the Phase 3 STELLAR-2 trial. Expert Opin Biol Ther. 2025 Oct;25(10):1121-1133. doi: 10.1080/14712598.2025.2576506. Epub 2025 Oct 21. | |
| 40708530 |
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The study was conducted in Europe and North America and enrolled patients across 41 sites in 5 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bmab1200 | Eligible patients were randomly assigned in a 1:1 ratio to receive Bmab 1200 or Stelara based on predefined stratification factors of geographic region (US vs Europe), body weight (≤100 kg vs >100 kg), previous exposure to biologic-based therapies (Yes vs No), and concomitant psoriatic arthritis (Yes vs No). Patients received study treatment at the baseline visit and Week 4. Patients weighing ≤100 kg received a subcutaneous dose of 45 mg of either drug at each of the above visits, while patients weighing >100 kg received a subcutaneous dose of 90 mg (45 mg × 2). |
| FG001 | Stelara | Eligible patients were randomly assigned in a 1:1 ratio to receive Bmab 1200 or Stelara based on predefined stratification factors of geographic region (US vs Europe), body weight (≤100 kg vs >100 kg), previous exposure to biologic-based therapies (Yes vs No), and concomitant psoriatic arthritis (Yes vs No). Patients received study treatment at the baseline visit and Week 4. Patients weighing ≤100 kg received a subcutaneous dose of 45 mg of either drug at each of the above visits, while patients weighing >100 kg received a subcutaneous dose of 90 mg (45 mg × 2). |
| FG002 | Bmab 1200- Bmab 1200 | Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200. This was done to obtain data after a single switch in patients who had been treated with Stelara. All continuing patients who received study treatment with Bmab 1200 at the baseline visit and Week 4 and achieved at least PASI 50 response by Week 12 were rerandomized before receiving study treatment at Week 16. This was done to maintain the study blinding, i.e. the patients in the original Bmab 1200 group went through the rerandomization procedure; however, they were assigned and continued to receive Bmab 1200. |
| FG003 | Stelara-Stelara | Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200. This was done to obtain data after a single switch in patients who had been treated with Stelara. All continuing patients who received study treatment with Bmab 1200 at the baseline visit and Week 4 and achieved at least PASI 50 response by Week 12 were rerandomized before receiving study treatment at Week 16. This was done to maintain the study blinding, i.e. the patients in the original Bmab 1200 group went through the rerandomization procedure; however, they were assigned and continued to receive Bmab 1200. |
| FG004 | Stelara-Bmab 1200 | Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200. This was done to obtain data after a single switch in patients who had been treated with Stelara. All continuing patients who received study treatment with Bmab 1200 at the baseline visit and Week 4 and achieved at least PASI 50 response by Week 12 were rerandomized before receiving study treatment at Week 16. This was done to maintain the study blinding, i.e. the patients in the original Bmab 1200 group went through the rerandomization procedure; however, they were assigned and continued to receive Bmab 1200. |
| FG005 | Bmab 1200/Bmab 1200 | All continuing patients who completed TP2 (received study treatment at the baseline visit and Weeks 4 and 16) and achieved at least PASI 75 response at Week 28 were offered to enter TP3 of the study to continue the same treatment that they were rerandomized to receive during TP2 (Bmab 1200 or Stelara) in a blinded manner. For patients not eligible to enter TP3, the end of study (EOS) visit occurred at Week 28. |
| FG006 | Stelara/Stelara | All continuing patients who completed TP2 (received study treatment at the baseline visit and Weeks 4 and 16) and achieved at least PASI 75 response at Week 28 were offered to enter TP3 of the study to continue the same treatment that they were rerandomized to receive during TP2 (Bmab 1200 or Stelara) in a blinded manner. For patients not eligible to enter TP3, the end of study (EOS) visit occurred at Week 28. |
| FG007 | Stelara/Bmab 1200 | All continuing patients who completed TP2 (received study treatment at the baseline visit and Weeks 4 and 16) and achieved at least PASI 75 response at Week 28 were offered to enter TP3 of the study to continue the same treatment that they were rerandomized to receive during TP2 (Bmab 1200 or Stelara) in a blinded manner. For patients not eligible to enter TP3, the end of study (EOS) visit occurred at Week 28. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Baseline to Week 16) |
| |||||||||||||
| Treatment Period 2 (Week 16 to Week 28) |
| |||||||||||||
| Treatment Period 3 (Week 28 to Week 52) |
|
Patient demographics and baseline characteristics provided on FAS which consist of all participants who signed the ICF and were randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Bmab1200 | Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Psoriasis Area and Severity Index (PASI) | Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12 | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Percentage change from baseline | Baseline to Week 12 |
|
Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bmab1200 | Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sarika D | Biocon Biologics Limited | 080 2808 | 5302 | Sarika.Deodhar@biocon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2023 | Jun 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2023 | Jun 26, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Double Blinded (Patient, Investigator),
| Bmab1200 | Biological | 45 mg , 90 mg at Week 0, 4, 16, 28 and 40 |
|
| 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 | Baseline through Week 28 |
| 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 | 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 | 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. | 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. | 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 | 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 | 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 | 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). | Baseline through Week 52 |
| Baseline through Week 28 and 52 |
| Safety:- Hypersensitivity | Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study | Baseline through Week 52 |
| Immunogenicity:-Developing Antidrug Antibodies | Proportion of patients developing antidrug antibodies | Baseline through Week 28 |
| Immunogenicity:-Developing Antidrug Antibodies | Proportion of patients developing antidrug antibodies | Postdosing Week 52 |
| Developing Neutralizing Antibodies | Proportion of patients neutralizing antibodies | Baseline through Week 28 |
| Developing Neutralizing Antibodies | Proportion of patients neutralizing antibodies | Postdosing Week 52 |
| Pharmacokinetic:-Serum Concentrations | Serum concentrations of ustekinumab | Postdosing on Week 28 |
| Pharmacokinetic:-Serum Concentrations | Serum concentrations of Ustekinumab | Postdosing on Week 52 |
| Derived |
| Szepietowski JC, Reich A, Feldman SR, Pulka G, Mekokishvili L, Tsiskarishvili N, Svarca I, Poder A, Singh G, Deodhar S, Kumar K, Marwah A, Loganathan S, Athalye SN, Wolff-Holz E. Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28-week results of the randomized, double-blind, Phase 3 STELLAR-2 study. Expert Opin Biol Ther. 2025 Aug;25(8):913-924. doi: 10.1080/14712598.2025.2538608. Epub 2025 Jul 29. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Subject |
|
| Region of Enrollment | Number | Subject |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Percentage change from Baseline in Score | Baseline through Week 28 |
|
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| 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 | Posted | Count of Participants | Participants | Baseline through Week 28 |
|
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| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline through Week 28 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Percentage of total body surface area | Baseline through Week 28 |
|
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline through Week 28 |
|
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline through Week 52 |
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| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline through Week 52 |
|
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| 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 | Posted | Mean | Standard Deviation | Change from Baseline in %BSA | Baseline through Week 52 |
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| 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 | Posted | Count of Participants | Participants | Baseline through week 52 |
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| Other Pre-specified | Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period | Posted | Count of Participants | Participants | Baseline to Week 52 |
|
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| Other Pre-specified | Safety:- Injection-site Reactions | Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study | NAb status with no injection site reactions being reported. | Posted | Baseline through Week 28 and 52 |
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| Other Pre-specified | Safety:- Hypersensitivity | Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study | Posted | Number | participants | Baseline through Week 52 |
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| Other Pre-specified | Immunogenicity:-Developing Antidrug Antibodies | Proportion of patients developing antidrug antibodies | n = number of patients with available data | Posted | Number | participants | Baseline through Week 28 |
|
|
|
| Other Pre-specified | Immunogenicity:-Developing Antidrug Antibodies | Proportion of patients developing antidrug antibodies | n = number of patients with available data | Posted | Number | participants | Postdosing Week 52 |
|
|
|
| Other Pre-specified | Developing Neutralizing Antibodies | Proportion of patients neutralizing antibodies | n = number of patients with available data | Posted | Number | participants | Baseline through Week 28 |
|
|
|
| Other Pre-specified | Developing Neutralizing Antibodies | Proportion of patients neutralizing antibodies | n = number of patients with available data | Posted | Number | participants | Postdosing Week 52 |
|
|
|
| Other Pre-specified | Pharmacokinetic:-Serum Concentrations | Serum concentrations of ustekinumab | Posted | Mean | Standard Deviation | ng/mL | Postdosing on Week 28 |
|
|
|
| Other Pre-specified | Pharmacokinetic:-Serum Concentrations | Serum concentrations of Ustekinumab | Posted | Mean | Standard Deviation | ng/mL | Postdosing on Week 52 |
|
|
|
| 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). | Posted | Mean | Standard Deviation | Percentage change from Baseline | Baseline through Week 52 |
|
|
|
| 0 |
| 191 |
| 6 |
| 191 |
| 111 |
| 191 |
| EG001 | 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 | 0 | 101 | 0 | 101 | 48 | 101 |
| EG002 | Stelara-Bmab1200 | Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg Subject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg | 0 | 92 | 1 | 92 | 51 | 92 |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Tonsillitis bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Bacteriuria | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Giardiasis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Sinusitis bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Tongue fungal infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Urinary tract infection fungal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Lipids increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood glucose abnormal | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Haemoglobin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| High density lipoprotein decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Acquired mixed hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Latent autoimmune diabetes in adults | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Metabolic syndrome | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Erythropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Secondary thrombocytosis | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Ketonuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperoxaluria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Sensitive skin | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Left atrial enlargement | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Illness anxiety disorder | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Essential hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
|
Data are the property of the Sponsor and cannot be published without prior authorization from the Sponsor, but data and publication thereof will not be unduly withheld.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| PASI 90 |
|
| Title | Measurements |
|---|---|
|
| PASI 90 |
|
|
| Angioedema |
|
| Rash maculo-papular |
|
| Abdominal pain |
|
| Jaundice cholestatic |
|
| Alcohol poisoning |
|
| Title | Measurements |
|---|---|
|
| Patients with no post baseline ADA result |
|
| Title | Measurements |
|---|---|
|
| Patients with no post baseline ADA result |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|