Trial Outcomes & Findings for Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT05335356)

NCT ID: NCT05335356

Last Updated: 2025-09-12

Results Overview

Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

384 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2025-09-12

Participant Flow

The study was conducted in Europe and North America and enrolled patients across 41 sites in 5 countries.

Participant milestones

Participant milestones
Measure	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).	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).	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.	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.	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.	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.	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.	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.
Treatment Period 1 (Baseline to Week 16) STARTED	191	193	0	0	0	0	0	0
Treatment Period 1 (Baseline to Week 16) COMPLETED	190	192	0	0	0	0	0	0
Treatment Period 1 (Baseline to Week 16) NOT COMPLETED	1	1	0	0	0	0	0	0
Treatment Period 2 (Week 16 to Week 28) STARTED	0	0	185	94	92	0	0	0
Treatment Period 2 (Week 16 to Week 28) COMPLETED	0	0	171	87	86	0	0	0
Treatment Period 2 (Week 16 to Week 28) NOT COMPLETED	0	0	14	7	6	0	0	0
Treatment Period 3 (Week 28 to Week 52) STARTED	0	0	0	0	0	168	81	84
Treatment Period 3 (Week 28 to Week 52) COMPLETED	0	0	0	0	0	163	79	82
Treatment Period 3 (Week 28 to Week 52) NOT COMPLETED	0	0	0	0	0	5	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bmab1200 n=191 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=193 Participants 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	Total n=384 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 13.09 • n=93 Participants	43.9 years STANDARD_DEVIATION 13.58 • n=4 Participants	43.2 years STANDARD_DEVIATION 13.34 • n=27 Participants
Sex: Female, Male Female	70 Participants n=93 Participants	57 Participants n=4 Participants	127 Participants n=27 Participants
Sex: Female, Male Male	121 Participants n=93 Participants	136 Participants n=4 Participants	257 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 Subject n=93 Participants	6 Subject n=4 Participants	12 Subject n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	185 Subject n=93 Participants	187 Subject n=4 Participants	372 Subject n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Subject n=93 Participants	0 Subject n=4 Participants	0 Subject n=27 Participants
Race/Ethnicity, Customized Asian	0 Subject n=93 Participants	0 Subject n=4 Participants	0 Subject n=27 Participants
Race/Ethnicity, Customized Black or African American	1 Subject n=93 Participants	1 Subject n=4 Participants	2 Subject n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Subject n=93 Participants	0 Subject n=4 Participants	0 Subject n=27 Participants
Race/Ethnicity, Customized White	190 Subject n=93 Participants	192 Subject n=4 Participants	382 Subject n=27 Participants
Race/Ethnicity, Customized Other	0 Subject n=93 Participants	0 Subject n=4 Participants	0 Subject n=27 Participants
Region of Enrollment Europe	189 Subject n=93 Participants	189 Subject n=4 Participants	378 Subject n=27 Participants
Region of Enrollment United States	2 Subject n=93 Participants	4 Subject n=4 Participants	6 Subject n=27 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Full Analysis Set

Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12

Outcome measures

Outcome measures
Measure	Bmab1200 n=191 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=193 Participants 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	Stelara-Bmab 1200 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Psoriasis Area and Severity Index (PASI)	-79.87 Percentage change from baseline Standard Error 2.818	-80.55 Percentage change from baseline Standard Error 2.783	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Bmab1200 n=168 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=81 Participants 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	Stelara-Bmab 1200 n=84 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
PASI Score	-95.50 Percentage change from Baseline in Score Standard Deviation 6.068	-96.01 Percentage change from Baseline in Score Standard Deviation 6.461	-95.44 Percentage change from Baseline in Score Standard Deviation 7.321	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Bmab1200 n=168 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=80 Participants 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	Stelara-Bmab 1200 n=84 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
PASI Improvement PASI 50	168 Participants	80 Participants	84 Participants	—	—	—
PASI Improvement PASI 75	168 Participants	79 Participants	83 Participants	—	—	—
PASI Improvement PASI 90	140 Participants	70 Participants	67 Participants	—	—	—

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Bmab1200 n=168 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=81 Participants 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	Stelara-Bmab 1200 n=84 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Static Physician's Global Assessment (sPGA)	-3.0 score on a scale Standard Deviation 1.21	-2.9 score on a scale Standard Deviation 1.21	-2.8 score on a scale Standard Deviation 1.28	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Bmab1200 n=168 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=81 Participants 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	Stelara-Bmab 1200 n=84 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Affected Body Surface Area	-26.52 Percentage of total body surface area Standard Deviation 15.152	-25.91 Percentage of total body surface area Standard Deviation 13.323	-28.33 Percentage of total body surface area Standard Deviation 17.251	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bmab1200 n=170 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=90 Participants 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	Stelara-Bmab 1200 n=88 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Dermatology Life Quality Index Scores	-12.2 score on a scale Standard Deviation 6.84	-10.5 score on a scale Standard Deviation 6.74	-12.2 score on a scale Standard Deviation 7.08	—	—	—

SECONDARY outcome

Timeframe: Baseline through Week 52

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.

Outcome measures

Outcome measures
Measure	Bmab1200 n=152 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=79 Participants 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	Stelara-Bmab 1200 n=79 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Dermatology Life Quality Index Scores	-12.8 score on a scale Standard Deviation 6.73	-11.5 score on a scale Standard Deviation 6.35	-12.7 score on a scale Standard Deviation 6.98	—	—	—

SECONDARY outcome

Timeframe: Baseline through Week 52

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

Outcome measures

Outcome measures
Measure	Bmab1200 n=163 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=80 Participants 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	Stelara-Bmab 1200 n=82 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Static Physician's Global Assessment (sPGA)	-3.1 score on a scale Standard Deviation 1.21	-3.0 score on a scale Standard Deviation 1.29	-2.9 score on a scale Standard Deviation 1.20	—	—	—

SECONDARY outcome

Timeframe: Baseline through Week 52

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

Outcome measures

Outcome measures
Measure	Bmab1200 n=163 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=80 Participants 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	Stelara-Bmab 1200 n=83 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Affected Body Surface Area	-27.42 Change from Baseline in %BSA Standard Deviation 15.119	-26.50 Change from Baseline in %BSA Standard Deviation 13.160	-28.90 Change from Baseline in %BSA Standard Deviation 17.560	—	—	—

SECONDARY outcome

Timeframe: Baseline through week 52

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

Outcome measures

Outcome measures
Measure	Bmab1200 n=163 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=80 Participants 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	Stelara-Bmab 1200 n=83 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
PASI Improvement PASI 50	163 Participants	80 Participants	83 Participants	—	—	—
PASI Improvement PASI 75	159 Participants	80 Participants	81 Participants	—	—	—
PASI Improvement PASI 90	133 Participants	70 Participants	63 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline through Week 52

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).

Outcome measures

Outcome measures
Measure	Bmab1200 n=163 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=81 Participants 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	Stelara-Bmab 1200 n=84 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
PASI Score	-95.50 Percentage change from Baseline Standard Deviation 7.507	-96.60 Percentage change from Baseline Standard Deviation 5.671	-94.71 Percentage change from Baseline Standard Deviation 7.950	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52

Outcome measures

Outcome measures
Measure	Bmab1200 n=191 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=101 Participants 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	Stelara-Bmab 1200 n=92 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period Endometrial adenocarcinoma	1 Participants	0 Participants	0 Participants	—	—	—
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	0 Participants	0 Participants	—	—	—
Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period Angioedema	0 Participants	1 Participants	0 Participants	—	—	—
Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period Rash maculo-papular	0 Participants	1 Participants	0 Participants	—	—	—
Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period Abdominal pain	1 Participants	0 Participants	0 Participants	—	—	—
Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period Jaundice cholestatic	1 Participants	0 Participants	0 Participants	—	—	—
Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period Alcohol poisoning	0 Participants	1 Participants	0 Participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Week 28 and 52

Population: NAb status with no injection site reactions being reported.

Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Week 52

Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study

Outcome measures

Outcome measures
Measure	Bmab1200 n=191 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=101 Participants 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	Stelara-Bmab 1200 n=92 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Safety:- Hypersensitivity	1 participants	3 participants	1 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Week 28

Population: n = number of patients with available data

Proportion of patients developing antidrug antibodies

Outcome measures

Outcome measures
Measure	Bmab1200 n=185 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=94 Participants 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	Stelara-Bmab 1200 n=92 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Immunogenicity:-Developing Antidrug Antibodies ADA positive	162 participants	88 participants	86 participants	—	—	—
Immunogenicity:-Developing Antidrug Antibodies ADA negative	21 participants	6 participants	5 participants	—	—	—
Immunogenicity:-Developing Antidrug Antibodies Patients with no post baseline ADA result	2 participants	0 participants	1 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Postdosing Week 52

Population: n = number of patients with available data

Proportion of patients developing antidrug antibodies

Outcome measures

Outcome measures
Measure	Bmab1200 n=168 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=81 Participants 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	Stelara-Bmab 1200 n=84 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Immunogenicity:-Developing Antidrug Antibodies ADA positive	131 participants	73 participants	74 participants	—	—	—
Immunogenicity:-Developing Antidrug Antibodies ADA negative	36 participants	8 participants	10 participants	—	—	—
Immunogenicity:-Developing Antidrug Antibodies Patients with no post baseline ADA result	1 participants	0 participants	0 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Week 28

Population: n = number of patients with available data

Proportion of patients neutralizing antibodies

Outcome measures

Outcome measures
Measure	Bmab1200 n=162 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=88 Participants 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	Stelara-Bmab 1200 n=86 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Developing Neutralizing Antibodies Nab reactive	54 participants	42 participants	31 participants	—	—	—
Developing Neutralizing Antibodies Nab negative	108 participants	46 participants	55 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Postdosing Week 52

Population: n = number of patients with available data

Proportion of patients neutralizing antibodies

Outcome measures

Outcome measures
Measure	Bmab1200 n=131 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=73 Participants 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	Stelara-Bmab 1200 n=74 Participants 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	Bmab 1200 (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Developing Neutralizing Antibodies Nab reactive	27 participants	19 participants	12 participants	—	—	—
Developing Neutralizing Antibodies Nab negative	104 participants	54 participants	62 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Postdosing on Week 28

Serum concentrations of ustekinumab

Outcome measures

Outcome measures
Measure	Bmab1200 n=130 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=61 Participants 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	Stelara-Bmab 1200 n=61 Participants 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	Bmab 1200 (2 Injection) n=36 Participants Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) n=15 Participants Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) n=20 Participants Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Pharmacokinetic:-Serum Concentrations	678.308 ng/mL Standard Deviation 444.7791	589.780 ng/mL Standard Deviation 418.9308	620.793 ng/mL Standard Deviation 398.1352	796.833 ng/mL Standard Deviation 392.6448	1070.600 ng/mL Standard Deviation 522.0039	861.665 ng/mL Standard Deviation 549.4014

OTHER_PRE_SPECIFIED outcome

Timeframe: Postdosing on Week 52

Serum concentrations of Ustekinumab

Outcome measures

Outcome measures
Measure	Bmab1200 n=127 Participants Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=60 Participants 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	Stelara-Bmab 1200 n=61 Participants 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	Bmab 1200 (2 Injection) n=35 Participants Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Stelara (2 Injection) n=17 Participants Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)	Stelara-Bmab 1200 ((2 Injection) n=20 Participants Patients who weigh \>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)
Pharmacokinetic:-Serum Concentrations	728.029 ng/mL Standard Deviation 477.1775	665.403 ng/mL Standard Deviation 379.9506	653.908 ng/mL Standard Deviation 415.8309	881.343 ng/mL Standard Deviation 510.0086	1008.382 ng/mL Standard Deviation 671.8667	898.450 ng/mL Standard Deviation 551.4494

Adverse Events

Bmab1200

Serious events: 6 serious events

Other events: 111 other events

Deaths: 0 deaths

Stelara

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Stelara-Bmab1200

Serious events: 1 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bmab1200 n=191 participants at risk Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40	Stelara n=101 participants at risk 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	Stelara-Bmab1200 n=92 participants at risk 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.52% 1/191 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/92 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Hepatobiliary disorders Cholecystitis acute	0.00% 0/191 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	1.1% 1/92 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.52% 1/191 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/92 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Cardiac disorders Acute myocardial infarction	0.52% 1/191 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/92 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Cardiac disorders Cardiac failure	0.52% 1/191 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/92 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Gastrointestinal disorders Abdominal pain	0.52% 1/191 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/92 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Hepatobiliary disorders Jaundice cholestatic	0.52% 1/191 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/92 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Reproductive system and breast disorders Uterovaginal prolapse	0.52% 1/191 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/92 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Nervous system disorders Ischaemic stroke	0.52% 1/191 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/101 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)	0.00% 0/92 • Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)

Other adverse events

Additional Information

Dr Sarika D

Biocon Biologics Limited

Phone: 080 2808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER