Trial Outcomes & Findings for A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis (NCT NCT03090100)

Last Updated: 2019-10-01

Results Overview

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1048 participants

Primary outcome timeframe

Week 48

Results posted on

2019-10-01

Participant Flow

Out of total 1,048 randomized participants, 534 were assigned to receive Guselkumab + Placebo and 514 subjects were assigned to receive Secukinumab.

Participant milestones

Participant milestones
Measure	Guselkumab 100 mg + Placebo Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Study STARTED	534	514
Overall Study Treated	534	511
Overall Study COMPLETED	507	466
Overall Study NOT COMPLETED	27	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Guselkumab 100 mg + Placebo Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Overall Study Adverse Event	9	11
Overall Study Pregnancy	1	1
Overall Study Lack of Efficacy	2	7
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	7	19
Overall Study Protocol Violation	2	6
Overall Study Non-compliance	2	0
Overall Study Other	2	2

Baseline Characteristics

A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.	Total n=1048 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	474 Participants n=5 Participants	467 Participants n=7 Participants	941 Participants n=5 Participants
Age, Categorical >=65 years	54 Participants n=5 Participants	45 Participants n=7 Participants	99 Participants n=5 Participants
Age, Continuous	46.3 years STANDARD_DEVIATION 13.67 • n=5 Participants	45.3 years STANDARD_DEVIATION 13.57 • n=7 Participants	45.8 years STANDARD_DEVIATION 13.63 • n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants	172 Participants n=7 Participants	341 Participants n=5 Participants
Sex: Female, Male Male	365 Participants n=5 Participants	342 Participants n=7 Participants	707 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	36 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	502 Participants n=5 Participants	472 Participants n=7 Participants	974 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	499 Participants n=5 Participants	480 Participants n=7 Participants	979 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment AUSTRALIA	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment CANADA	81 Participants n=5 Participants	77 Participants n=7 Participants	158 Participants n=5 Participants
Region of Enrollment CZECH REPUBLIC	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment FRANCE	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment GERMANY	66 Participants n=5 Participants	56 Participants n=7 Participants	122 Participants n=5 Participants
Region of Enrollment HUNGARY	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment POLAND	119 Participants n=5 Participants	119 Participants n=7 Participants	238 Participants n=5 Participants
Region of Enrollment SPAIN	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Region of Enrollment UNITED STATES	118 Participants n=5 Participants	115 Participants n=7 Participants	233 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 90 non-responders at Week 48.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48	84.5 Percentage of participants	70.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 12 and 48

Population: FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 12 or 48 were considered as non-responders for this endpoint.

Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48	84.6 Percentage of participants	80.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS population included. Participants who met treatment failure criteria prior to Week 12, who had a missing PASI score at Week 12 were considered PASI 90 non-responders at Week 12.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a PASI-90 Response at Week 12	69.1 Percentage of participants	76.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS population included. Participants who met treatment failure criteria prior to Week 12 or who had a missing PASI score at Week 12 were considered PASI 75 non-responders at Week 12.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a PASI-75 Response at Week 12	89.3 Percentage of participants	91.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 100 non-responders at Week 48.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a PASI-100 Response at Week 48	58.2 Percentage of participants	48.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) non-responders at Week 48.

The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48	62.2 Percentage of participants	50.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) or minimal (1) non-responders at Week 48.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48	85.0 Percentage of participants	74.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 16 and 48

Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 16 or 48 were considered as non-responders for this endpoint.

Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48	72.3 Percentage of participants	64.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 75 non-responders at Week 16.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a PASI-75 Response at Week 16	92.7 Percentage of participants	92.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a PASI-90 Response at Week 16	78.5 Percentage of participants	79.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 24 up to Week 48

Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at any visit from Week 24 through 48 were considered as non-responders for this endpoint.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48	71.0 Percentage of participants	61.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing IGA score at Week 16 were considered non-responders for this endpoint.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16	86.7 Percentage of participants	86.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 12 or who had a missing IGA score at Week 12 were considered non-responders for this endpoint.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12	85.6 Percentage of participants	86.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Full analysis set included all the participants randomized at Week 0 and who achieved PASI 75 response at Week 12. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=477 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=471 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12	94.8 Percentage of participants	87.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Full analysis set included all the participants randomized at Week 0 and who achieved PASI-90 response at Week 16. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=419 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=409 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16	92.1 Percentage of participants	80.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56

Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing PASI score were considered as non-responders for the specific visit.

PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with \>=50%, \>= 75%, \>=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 1: >=75% improvement	2.1 Percentage of participants	1.8 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 12: 100% improvement	37.8 Percentage of participants	42.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 12: >=50% improvement	96.8 Percentage of participants	96.1 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 28: >=50% improvement	97.2 Percentage of participants	93.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 40: 100% improvement	58.2 Percentage of participants	48.6 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 48: >=90% improvement	84.5 Percentage of participants	70.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 40: >=50% improvement	95.9 Percentage of participants	90.9 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 48: >=75% improvement	92.1 Percentage of participants	83.5 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 48: >=50% improvement	94.0 Percentage of participants	89.3 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 56: 100% improvement	50.4 Percentage of participants	27.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 56: >=90% improvement	77.3 Percentage of participants	51.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 56: >=75% improvement	88.0 Percentage of participants	70.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 44: 100% improvement	58.6 Percentage of participants	49.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 44: >=90% improvement	84.1 Percentage of participants	72.6 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 44: >=75% improvement	92.3 Percentage of participants	85.2 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 56: >=50% improvement	91.0 Percentage of participants	82.1 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 16: >=75% improvement	92.7 Percentage of participants	92.8 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 44: >=50% improvement	94.2 Percentage of participants	91.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 48: 100% improvement	58.2 Percentage of participants	48.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 1: 100% improvement	0 Percentage of participants	0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 1: >=90% improvement	0 Percentage of participants	0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 1: >=50% improvement	10.7 Percentage of participants	12.8 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 2: 100% improvement	0.2 Percentage of participants	0.6 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 2: >=90% improvement	1.1 Percentage of participants	2.7 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 2: >=75% improvement	6.4 Percentage of participants	11.5 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 2: >=50% improvement	30.9 Percentage of participants	42.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 3: 100% improvement	1.7 Percentage of participants	1.6 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 3: >=90% improvement	5.6 Percentage of participants	8.6 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 3: >=75% improvement	19.5 Percentage of participants	28.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 3: >=50% improvement	56.4 Percentage of participants	66.9 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 4: 100% improvement	4.1 Percentage of participants	5.1 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 4: >=90% improvement	13.1 Percentage of participants	21.8 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 4: >=75% improvement	39.3 Percentage of participants	50.2 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 4: >=50% improvement	73.4 Percentage of participants	85.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 8: 100% improvement	20.0 Percentage of participants	27.2 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 8: >=90% improvement	48.7 Percentage of participants	62.1 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 8: >=75% improvement	76.4 Percentage of participants	86.2 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 8: >=50% improvement	95.3 Percentage of participants	96.9 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 12: >=90% improvement	69.1 Percentage of participants	76.1 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 12: >=75% improvement	89.3 Percentage of participants	91.6 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 16: 100% improvement	47.8 Percentage of participants	46.1 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 16: >=90% improvement	78.5 Percentage of participants	79.6 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 16: >=50% improvement	97.6 Percentage of participants	96.3 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 20: 100% improvement	51.3 Percentage of participants	48.6 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 20: >=90% improvement	80.1 Percentage of participants	81.1 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 20: >=75% improvement	93.6 Percentage of participants	92.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 20: >=50% improvement	97.6 Percentage of participants	95.1 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 24: 100% improvement	54.7 Percentage of participants	50.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 24: >=90% improvement	83.1 Percentage of participants	78.2 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 24: >=75% improvement	94.2 Percentage of participants	90.3 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 24: >=50% improvement	97.8 Percentage of participants	93.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 28: 100% improvement	57.1 Percentage of participants	51.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 28: >=90% improvement	85.4 Percentage of participants	77.2 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 28: >=75% improvement	94.0 Percentage of participants	90.3 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 32: 100% improvement	57.5 Percentage of participants	50.2 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 32:>=90 % improvement	84.8 Percentage of participants	77.4 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 32: >=75% improvement	94.0 Percentage of participants	89.3 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 32: >=50% improvement	97.0 Percentage of participants	93.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 36: 100% improvement	58.6 Percentage of participants	50.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 36: >=90% improvement	84.5 Percentage of participants	75.7 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 36: >=75% improvement	93.6 Percentage of participants	87.0 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 36: >=50% improvement	97.2 Percentage of participants	92.2 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 40: >=90% improvement	84.6 Percentage of participants	73.7 Percentage of participants
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 Week 40: >=75% improvement	92.9 Percentage of participants	85.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56

Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing IGA score were considered as non-responders for the specific visit.

Outcome measures

Outcome measures
Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percentage of Participants With IGA Responses Through Week 56 Week 1: cleared (0)	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 16: cleared (0) or minimal (1)	86.7 Percentage of participants	86.6 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 24: cleared (0) or minimal (1)	88.6 Percentage of participants	82.7 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 44: cleared (0) or minimal (1)	86.0 Percentage of participants	76.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 44: mild or better (=<2)	92.3 Percentage of participants	87.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 1: cleared (0) or minimal (1)	3.4 Percentage of participants	2.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 1: mild or better (=<2)	27.2 Percentage of participants	34.2 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 2: cleared (0)	0.2 Percentage of participants	0.8 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 2: cleared (0) or minimal (1)	12.4 Percentage of participants	20.2 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 2: mild or better (=<2)	54.1 Percentage of participants	63.8 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 3: cleared (0)	2.6 Percentage of participants	3.3 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 3: cleared (0) or minimal (1)	27.2 Percentage of participants	39.9 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 3: mild or better (=<2)	75.3 Percentage of participants	82.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 4: cleared (0)	6.7 Percentage of participants	9.7 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 4: cleared (0) or minimal (1)	44.2 Percentage of participants	59.3 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 4: mild or better (=<2)	85.6 Percentage of participants	92.2 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 8: cleared (0)	29.2 Percentage of participants	35.8 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 8: cleared (0) or minimal (1)	76.6 Percentage of participants	83.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 8: mild or better (=<2)	96.3 Percentage of participants	96.3 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 12: cleared (0)	46.3 Percentage of participants	50.2 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 12: cleared (0) or minimal (1)	85.6 Percentage of participants	86.4 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 12: mild or better (=<2)	96.8 Percentage of participants	95.3 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 16: cleared (0)	55.4 Percentage of participants	53.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 16: mild or better (=<2)	96.8 Percentage of participants	94.7 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 20: cleared (0)	56.9 Percentage of participants	53.9 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 20: cleared (0) or minimal (1)	87.8 Percentage of participants	85.6 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 20: mild or better (=<2)	95.3 Percentage of participants	93.2 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 24: cleared (0)	61.0 Percentage of participants	56.0 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 24: mild or better (=<2)	96.3 Percentage of participants	91.6 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 28: cleared (0)	62.2 Percentage of participants	56.2 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 28: cleared (0) or minimal (1)	87.8 Percentage of participants	82.9 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 28: mild or better (<=2)	95.5 Percentage of participants	90.9 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 32: cleared (0)	63.1 Percentage of participants	54.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 32: cleared (0) or minimal (1)	88.6 Percentage of participants	81.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 32: mild or better (=<2)	95.5 Percentage of participants	90.5 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 36: cleared (0)	60.7 Percentage of participants	53.7 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 36: cleared (0) or minimal (1)	86.5 Percentage of participants	79.6 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 36: mild or better (=<2)	95.5 Percentage of participants	88.9 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 40: cleared (0)	63.1 Percentage of participants	52.3 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 40: cleared (0) or minimal (1)	86.3 Percentage of participants	78.0 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 40: mild or better (=<2)	93.6 Percentage of participants	87.9 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 44: cleared (0)	62.2 Percentage of participants	51.9 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 48: cleared (0)	62.2 Percentage of participants	50.4 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 48: cleared (0) or minimal (1)	85.0 Percentage of participants	74.9 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 48: mild or better (=<2)	92.7 Percentage of participants	86.8 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 56: cleared (0)	54.3 Percentage of participants	29.4 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 56: cleared (0) or minimal (1)	78.8 Percentage of participants	58.2 Percentage of participants
Percentage of Participants With IGA Responses Through Week 56 Week 56: mild or better (=<2)	87.5 Percentage of participants	76.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56

Population: Full analysis set included all the participants randomized at Week 0. Here 'n' signifies the number of participants analyzed at specified point. Zero percent improvement was assigned from the point when participants met treatment failure criteria and no other data imputation was applied.

Outcome measures

Adverse Events

Guselkumab 100 mg + Placebo

Serious events: 33 serious events

Other events: 249 other events

Deaths: 0 deaths

Secukinumab 300 mg

Serious events: 37 serious events

Other events: 254 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Guselkumab 100 mg + Placebo n=534 participants at risk Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=511 participants at risk Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Gastrointestinal disorders Diarrhoea	5.1% 27/534 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.	3.9% 20/511 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
Infections and infestations Nasopharyngitis	22.1% 118/534 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.	24.5% 125/511 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
Infections and infestations Upper Respiratory Tract Infection	15.5% 83/534 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.	18.0% 92/511 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 30/534 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.	4.9% 25/511 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
Musculoskeletal and connective tissue disorders Back Pain	5.4% 29/534 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.	3.5% 18/511 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
Nervous system disorders Headache	9.0% 48/534 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.	9.4% 48/511 • Up to Week 56 Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.

Additional Information

Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Guselkumab 100 mg + Placebo n=534 Participants Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Secukinumab 300 mg n=514 Participants Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Percent Improvement From Baseline in PASI Through Week 56 Week 1	20.30 Percent improvement Standard Deviation 20.743	24.72 Percent improvement Standard Deviation 20.711
Percent Improvement From Baseline in PASI Through Week 56 Week 16	93.65 Percent improvement Standard Deviation 12.849	93.94 Percent improvement Standard Deviation 12.123
Percent Improvement From Baseline in PASI Through Week 56 Week 24	95.27 Percent improvement Standard Deviation 9.848	93.75 Percent improvement Standard Deviation 14.314
Percent Improvement From Baseline in PASI Through Week 56 Week 28	95.58 Percent improvement Standard Deviation 9.663	92.96 Percent improvement Standard Deviation 16.835
Percent Improvement From Baseline in PASI Through Week 56 Week 2	37.85 Percent improvement Standard Deviation 23.567	44.56 Percent improvement Standard Deviation 23.600
Percent Improvement From Baseline in PASI Through Week 56 Week 3	52.76 Percent improvement Standard Deviation 24.186	60.57 Percent improvement Standard Deviation 21.871
Percent Improvement From Baseline in PASI Through Week 56 Week 4	64.63 Percent improvement Standard Deviation 22.862	72.80 Percent improvement Standard Deviation 19.478
Percent Improvement From Baseline in PASI Through Week 56 Week 8	84.36 Percent improvement Standard Deviation 17.278	89.40 Percent improvement Standard Deviation 13.579
Percent Improvement From Baseline in PASI Through Week 56 Week 12	90.85 Percent improvement Standard Deviation 14.484	92.60 Percent improvement Standard Deviation 13.703
Percent Improvement From Baseline in PASI Through Week 56 Week 20	94.35 Percent improvement Standard Deviation 11.525	94.41 Percent improvement Standard Deviation 12.152
Percent Improvement From Baseline in PASI Through Week 56 Week 32	95.74 Percent improvement Standard Deviation 9.336	92.95 Percent improvement Standard Deviation 16.641
Percent Improvement From Baseline in PASI Through Week 56 Week 36	95.45 Percent improvement Standard Deviation 11.119	92.40 Percent improvement Standard Deviation 17.125
Percent Improvement From Baseline in PASI Through Week 56 Week 40	95.78 Percent improvement Standard Deviation 10.456	91.77 Percent improvement Standard Deviation 17.733
Percent Improvement From Baseline in PASI Through Week 56 Week 44	95.45 Percent improvement Standard Deviation 12.293	91.34 Percent improvement Standard Deviation 18.246
Percent Improvement From Baseline in PASI Through Week 56 Week 48	95.76 Percent improvement Standard Deviation 11.629	90.87 Percent improvement Standard Deviation 19.181
Percent Improvement From Baseline in PASI Through Week 56 Week 56	93.35 Percent improvement Standard Deviation 16.116	81.67 Percent improvement Standard Deviation 27.627