Trial Outcomes & Findings for Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT04785326)

Last Updated: 2024-01-18

Results Overview

Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms. If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

598 participants

Primary outcome timeframe

Week 8 (For EMA) and 12 (For FDA)

Results posted on

2024-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	DMB-3115 Patients randomized to receive DMB-3115 at the beginning of the study and continued to receive the same treatment DMB-3115: 45mg or 90mg dose subcutaneous administration	Stelara Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to continue on Stelara Stelara: 45mg or 90mg dose subcutaneous administration	Switch to DMB-3115 Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to be transitioned to receive DMB-3115 DMB-3115: 45mg or 90mg dose subcutaneous administration Stelara: 45mg or 90mg dose subcutaneous administration
Period 1 (Week 1 to 28) STARTED	299	299	0
Period 1 (Week 1 to 28) COMPLETED	268	263	0
Period 1 (Week 1 to 28) NOT COMPLETED	31	36	0
Period 2 (Week 28 to 52) STARTED	268	132	131
Period 2 (Week 28 to 52) COMPLETED	258	130	124
Period 2 (Week 28 to 52) NOT COMPLETED	10	2	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DMB-3115 n=299 Participants Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment DMB-3115: 45mg or 90mg dose subcutaneous administration	Stelara n=299 Participants Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115 DMB-3115: 45mg or 90mg dose subcutaneous administration Stelara: 45mg or 90mg dose subcutaneous administration	Total n=598 Participants Total of all reporting groups
Age, Continuous	45.4 years STANDARD_DEVIATION 13.03 • n=5 Participants	45.7 years STANDARD_DEVIATION 13.46 • n=7 Participants	45.6 years STANDARD_DEVIATION 13.23 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	87 Participants n=7 Participants	184 Participants n=5 Participants
Sex: Female, Male Male	202 Participants n=5 Participants	212 Participants n=7 Participants	414 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Ethnicity : Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Ethnicity : Not Hispanic or Latino	297 Participants n=5 Participants	294 Participants n=7 Participants	591 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Ethnicity : Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	295 Participants n=5 Participants	298 Participants n=7 Participants	593 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment Europe	273 participants n=5 Participants	270 participants n=7 Participants	543 participants n=5 Participants
Region of Enrollment Georgia	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Ukraine	13 participants n=5 Participants	16 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 8 (For EMA) and 12 (For FDA)

Population: Per protocol set for EMA, Intention-to-Treat set for FDA

Outcome measures

Outcome measures
Measure	DMB-3115 n=299 Participants Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment DMB-3115: 45mg or 90mg dose subcutaneous administration	Stelara n=299 Participants Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115 DMB-3115: 45mg or 90mg dose subcutaneous administration Stelara: 45mg or 90mg dose subcutaneous administration
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara Week 8 (for EMA)	77.5 percent change in PASI score Standard Error 2.595	77.85 percent change in PASI score Standard Error 2.587
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara Week 12 (for FDA)	87.59 percent change in PASI score Standard Error 1.886	87.89 percent change in PASI score Standard Error 1.884

Adverse Events

DMB-3115 (Period 1)

Serious events: 5 serious events

Other events: 73 other events

Deaths: 2 deaths

Stelara (Period 1)

Serious events: 3 serious events

Other events: 90 other events

Deaths: 1 deaths

DMB-3115 (Period 2)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Stelara (Period 2)

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Switch to DMB-3115 (Period 2)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DMB-3115 (Period 1) n=299 participants at risk Patients randomized to receive DMB-3115 at the beginning of the study DMB-3115: 45mg or 90mg dose subcutaneous administration	Stelara (Period 1) n=299 participants at risk Patients randomized to receive Stelara at the beginning of the study Stelara: 45mg or 90mg dose subcutaneous administration	DMB-3115 (Period 2) n=267 participants at risk Patients randomized to receive DMB-3115 at the beginning of the study and continued to receive the same treatment DMB-3115: 45mg or 90mg dose subcutaneous administration	Stelara (Period 2) n=132 participants at risk Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to continue on Stelara Stelara: 45mg or 90mg dose subcutaneous administration	Switch to DMB-3115 (Period 2) n=131 participants at risk Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to be transitioned to receive DMB-3115 DMB-3115: 45mg or 90mg dose subcutaneous administration Stelara: 45mg or 90mg dose subcutaneous administration
Cardiac disorders Acute myocardial infarction	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Cardiac disorders Atrial fibrillation	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
General disorders Sudden cardiac death	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Infections and infestations COVID-19	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Infections and infestations COVID-19 pneumonia	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Injury, poisoning and procedural complications Humerus fracture	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.76% 1/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.76% 1/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Nervous system disorders Vith nerve paralysis	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.33% 1/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Vascular disorders Hypertension	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.76% 1/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.

Other adverse events

Other adverse events
Measure	DMB-3115 (Period 1) n=299 participants at risk Patients randomized to receive DMB-3115 at the beginning of the study DMB-3115: 45mg or 90mg dose subcutaneous administration	Stelara (Period 1) n=299 participants at risk Patients randomized to receive Stelara at the beginning of the study Stelara: 45mg or 90mg dose subcutaneous administration	DMB-3115 (Period 2) n=267 participants at risk Patients randomized to receive DMB-3115 at the beginning of the study and continued to receive the same treatment DMB-3115: 45mg or 90mg dose subcutaneous administration	Stelara (Period 2) n=132 participants at risk Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to continue on Stelara Stelara: 45mg or 90mg dose subcutaneous administration	Switch to DMB-3115 (Period 2) n=131 participants at risk Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to be transitioned to receive DMB-3115 DMB-3115: 45mg or 90mg dose subcutaneous administration Stelara: 45mg or 90mg dose subcutaneous administration
Infections and infestations Upper respiratory tract infection	1.3% 4/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	3.7% 11/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	1.1% 3/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.76% 1/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Nervous system disorders Headache	3.0% 9/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	2.3% 7/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	1.5% 4/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	3.0% 4/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	1.5% 2/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Vascular disorders Hypertension	3.7% 11/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	4.0% 12/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.37% 1/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	1.5% 2/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	2.3% 3/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Infections and infestations Nasopharyngitis	8.0% 24/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	11.0% 33/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	1.5% 4/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	3.0% 4/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	2.3% 3/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Infections and infestations COVID-19	4.7% 14/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	6.0% 18/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	1.5% 4/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	1.5% 2/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	2.3% 3/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
Infections and infestations Rhinitis	3.7% 11/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	3.0% 9/299 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.37% 1/267 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	1.5% 2/132 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.	0.00% 0/131 • Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks. Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn. So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.

Additional Information

Clinical Research Manager

Dong-A ST

Phone: 02-920-1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place