Trial Outcomes & Findings for A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis (NCT NCT04633447)

Last Updated: 2025-07-01

Results Overview

GC free remission at Week 28 was defined as (1) no signs or symptoms of active Giant cell arteritis (GCA) at Week 28; (2) absence of GCA flare from first dose of the study drug through Week 28; and (3) adherence to the protocol specified 26-week GC taper regimen. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Week 28

Results posted on

2025-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Guselkumab Initially, subjects received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks Week 0 until Week 48 (end of treatment). Eligible subjects who were in GC-free remission at Week 48 and consented for the long term extension (LTE) period, continued to receive Guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose up to Week 112. Participants who did not enter LTE continued in the main study till Week 60.	Placebo Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Eligible participants who were in GC-free remission at Week 48 and consented for the LTE period, continued to receive placebo matching to guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Participants were then followed up for safety for 12 weeks after the last dose up to Week 112. Participants who did not enter LTE continued in the main study till Week 60.
Main Study (From Week 0 up to Week 60) STARTED	35	18
Main Study (From Week 0 up to Week 60) Participants Enrolled Post PA-5 Who Received Placebo Matching to Guselkumab 200 mg From Week 0	0	11
Main Study (From Week 0 up to Week 60) Participants Enrolled Post PA-5 Who Received Guselkumab 200 mg From Week 0	19	0
Main Study (From Week 0 up to Week 60) COMPLETED	22	12
Main Study (From Week 0 up to Week 60) NOT COMPLETED	13	6
LTE Period (Week 52 up to Week 112) STARTED	9	6
LTE Period (Week 52 up to Week 112) COMPLETED	5	3
LTE Period (Week 52 up to Week 112) NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Guselkumab Initially, subjects received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks Week 0 until Week 48 (end of treatment). Eligible subjects who were in GC-free remission at Week 48 and consented for the long term extension (LTE) period, continued to receive Guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose up to Week 112. Participants who did not enter LTE continued in the main study till Week 60.	Placebo Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Eligible participants who were in GC-free remission at Week 48 and consented for the LTE period, continued to receive placebo matching to guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Participants were then followed up for safety for 12 weeks after the last dose up to Week 112. Participants who did not enter LTE continued in the main study till Week 60.
Main Study (From Week 0 up to Week 60) Adverse Event	8	2
Main Study (From Week 0 up to Week 60) Study terminated by sponsor	3	3
Main Study (From Week 0 up to Week 60) Physician Decision	0	1
Main Study (From Week 0 up to Week 60) Withdrawal by Subject	2	0
LTE Period (Week 52 up to Week 112) Study Terminated by Sponsor	3	2
LTE Period (Week 52 up to Week 112) Adverse Event	1	1

Baseline Characteristics

A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guselkumab n=35 Participants Initially, subjects received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks Week 0 until Week 48 (end of treatment). Eligible subjects who were in GC-free remission at Week 48 and consented for the long term extension (LTE) period, continued to receive Guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose up to Week 112. Participants who did not enter LTE continued in the main study till Week 60.	Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Eligible participants who were in GC-free remission at Week 48 and consented for the LTE period, continued to receive placebo matching to guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Participants were then followed up for safety for 12 weeks after the last dose up to Week 112. Participants who did not enter LTE continued in the main study till Week 60.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	15 Participants n=7 Participants	44 Participants n=5 Participants
Age, Continuous	71.9 years STANDARD_DEVIATION 7.65 • n=5 Participants	70.8 years STANDARD_DEVIATION 7.14 • n=7 Participants	71.5 years STANDARD_DEVIATION 7.43 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	12 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	15 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	18 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Canada	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment France	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Germany	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Israel	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Italy	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Poland	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Spain	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 28

Population: Full analysis set (FAS) included all randomized participants who received at least 1 administration of study intervention.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28	40.0 Percentage of Participants	33.3 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 28, 32, 36, 40, 44, 48 and 52

Population: FAS included all randomized participants who received at least 1 administration of study intervention.

GC free remission was defined as (1) no signs or symptoms of active GCA at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively; (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52; (3) adherence to the protocol specified 26-week GC taper regimen. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 40	34.3 Percentage of Participants	33.3 Percentage of Participants
Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 28	40.0 Percentage of Participants	33.3 Percentage of Participants
Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 32	34.3 Percentage of Participants	33.3 Percentage of Participants
Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 36	34.3 Percentage of Participants	33.3 Percentage of Participants
Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 44	34.3 Percentage of Participants	33.3 Percentage of Participants
Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 48	31.4 Percentage of Participants	27.8 Percentage of Participants
Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 52	25.7 Percentage of Participants	27.8 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 28, 32, 36, 40, 44, 48 and 52

Population: FAS included all randomized participants who received at least 1 administration of study intervention.

GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active GCA at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52 (3) adherence to the protocol specified 26-week GC taper regimen. Normalization of ESR was defined as ESR less than (\<) 30 millimeter per hour (mm/hr) at Weeks 28, 32, 36, 40, 44, 48 and 52. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 28	22.9 Percentage of Participants	5.6 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 32	22.9 Percentage of Participants	11.1 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 36	22.9 Percentage of Participants	16.7 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 40	25.7 Percentage of Participants	16.7 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 44	22.9 Percentage of Participants	11.1 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 48	20.0 Percentage of Participants	22.2 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 52	22.9 Percentage of Participants	16.7 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 28, 32, 36, 40, 44, 48 and 52

Population: FAS included all randomized participants who received at least 1 administration of study intervention.

GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active Giant cell arteritis (GCA) at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52 (3) adherence to the protocol specified 26-week GC taper regimen. Normalization of CRP is defined as CRP \<10 milligrams per liter (mg/L) or \<1 milligrams per deciliter (mg/dL). GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 28	22.9 Percentage of Participants	16.7 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 32	20.0 Percentage of Participants	16.7 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 36	25.7 Percentage of Participants	22.2 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 40	28.6 Percentage of Participants	33.3 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 44	25.7 Percentage of Participants	27.8 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 48	20.0 Percentage of Participants	27.8 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 52	17.1 Percentage of Participants	22.2 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 28, 32, 36, 40, 44, 48 and 52

Population: FAS included all randomized participants who received at least 1 administration of study intervention.

GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active GCA at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively; (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52; (3) adherence to the protocol specified 26-week GC taper regimen. Normalization of ESR is defined as ESR \< 30 mm/hr at Weeks 28, 32, 36, 40, 44, 48 and 52. Normalization of CRP is defined as CRP \<10 mg/L or \<1 mg/dL. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 28	14.3 Percentage of Participants	5.6 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 32	17.1 Percentage of Participants	11.1 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 36	20.0 Percentage of Participants	16.7 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 40	22.9 Percentage of Participants	16.7 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 44	17.1 Percentage of Participants	11.1 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 48	14.3 Percentage of Participants	22.2 Percentage of Participants
Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 At Week 52	17.1 Percentage of Participants	16.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Weeks 28 and 52

Population: FAS included all randomized participants who received at least 1 administration of study intervention.

Total cumulative GC dose administered included GCA taper, GC rescue therapy as well as for all other indications (any oral GC) from baseline (Day 1) up to Weeks 28 and 52 was reported.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Cumulative Glucocorticoid (GC) Dose Baseline (Day 1) up to Week 28	2231.0 Milligrams (mg) Interval 1315.0 to 4146.0	2205.0 Milligrams (mg) Interval 1736.0 to 6010.0
Main Study: Cumulative Glucocorticoid (GC) Dose Baseline (Day 1) up to Week 52	2418.5 Milligrams (mg) Interval 1315.0 to 4319.0	2902.1 Milligrams (mg) Interval 1736.0 to 7345.0

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30 and Week 52

Population: FAS included all randomized participants who received at least 1 administration of study intervention. Here, N (Overall Number of Participants analyzed) signifies participants with at least 1 disease flare or discontinuation of study intervention due to AE of Worsening of GCA.

Time to occurrence of GCA disease flare was defined as the time from first dose of the study agent to the occurrence of the first observation of GCA disease flare or discontinuation due to adverse event (AE) of worsening of GCA. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Time to First GCA Disease Flare or Discontinuation of Study Intervention Due to Adverse Event (AE) of Worsening of GCA Baseline (Day 1) up to Week 30	NA Weeks Interval 27.71 to Median and upper limit of 90% confidence interval (CI) could not be estimated due to low number of participants with events.	29.71 Weeks Interval 20.14 to Upper limit of 90% CI could not be estimated due to low number of participants with events.
Main Study: Time to First GCA Disease Flare or Discontinuation of Study Intervention Due to Adverse Event (AE) of Worsening of GCA Baseline (Day 1) up to Week 52	NA Weeks Interval 27.71 to Median and upper limit of 90% CI could not be estimated due to low number of participants with events.	30.07 Weeks Interval 20.14 to Upper limit of 90% CI could not be estimated due to low number of participants with events.

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30 and Week 52

Population: FAS included all randomized participants who received at least 1 administration of study intervention.

Number of participants with GCA disease flares or discontinuation of study intervention due to AE of worsening of GCA were reported. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA Baseline up to Week 30: 1 Flare	10 Participants	8 Participants
Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA Baseline up to Week 30: 2 Flares	0 Participants	0 Participants
Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA Baseline up to Week 30: >=3 Flares	0 Participants	0 Participants
Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA Baseline up to Week 52: 1 Flare	13 Participants	7 Participants
Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA Baseline up to Week 52: 2 Flares	3 Participants	3 Participants
Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA Baseline up to Week 52: >=3 Flares	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 60

Population: Safety analysis set included all participants who received at least 1 dose of study intervention.

Number of participants with TEAEs (including serious and non-serious AEs) were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	34 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 60

Population: Safety analysis set included all participants who received at least 1 dose of study intervention.

Number of participants with TEAEs (including serious and non-serious AEs) by SOC with a frequency threshold of 5 percent (%) or more were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Infections and infestations	21 Participants	11 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Musculoskeletal and connective tissue disorders	19 Participants	5 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Vascular disorders	18 Participants	11 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Gastrointestinal disorders	10 Participants	2 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More General disorders and administration site conditions	10 Participants	6 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Nervous system disorders	9 Participants	9 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Eye disorders	8 Participants	3 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Respiratory, thoracic and mediastinal disorders	8 Participants	4 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Skin and subcutaneous tissue disorders	8 Participants	1 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Injury, poisoning and procedural complications	7 Participants	2 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Investigations	6 Participants	0 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Endocrine disorders	5 Participants	0 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Psychiatric disorders	4 Participants	1 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Metabolism and nutrition disorders	3 Participants	1 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Neoplasms benign, malignant and unspecified (incl cysts and polyps)	3 Participants	1 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Cardiac disorders	2 Participants	2 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Renal and urinary disorders	2 Participants	1 Participants
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More Reproductive system and breast disorders	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 60

Population: Safety analysis set included all participants who received at least 1 dose of study intervention.

Number of participants with treatment emergent SAEs were reported. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurred at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs)	6 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 60

Population: Safety analysis set included all participants who received at least 1 dose of study intervention and had at least one post baseline value for the specified vital sign parameter. Here, "n"(number analyzed) signifies number of participants analyzed at specified categories

Number of participants with clinically significant abnormalities in vital signs were reported. Clinically significant abnormal vital signs criteria: Pulse rate: \<50 beats per minutes (bpm) and with greater than (\>) 20 bpm decrease from baseline, \>115 bpm and with \>30 bpm increase from baseline; Systolic blood pressure (SBP): \<90 millimeters of mercury \[mmHg\] and with \>30 mmHg decrease from baseline, \>150 mmHg and with \>40 mmHg increase from baseline; Diastolic blood pressure (DBP): \<50 mmHg and with \>20 mmHg decrease from baseline, \>95 mmHg and with \>30 mmHg increase from baseline; Interarm blood pressure: Interarm blood pressure difference greater than or equal to (\>=) 15 mmHg in systolic blood pressure at 3 consecutive visits; Temperature (Temp): \>38.4 Degree Celsius (C) and with \>=1 C increase from baseline; Weight (kilogram \[kg\]): decrease 10 percent (%) from baseline, increase 10% from baseline; Respiratory Rate: \>20 breaths per minute.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Systolic BP: >150 mmHg and >40 mmHg increase	0 Participants	2 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Diastolic BP: <50 mmHg and >20 mmHg decrease	2 Participants	0 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Diastolic BP: >95 mmHg and >30 mmHg increase	1 Participants	1 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Interarm BP:BP difference >=15 mmHg in systolic BP	2 Participants	2 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Temp: >38.4 C and >=1 C increase from baseline	0 Participants	0 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Weight: Decrease 10% from baseline	0 Participants	1 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Weight: Increase 10% from baseline	6 Participants	2 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Respiratory Rate: >20 breaths per minute	1 Participants	4 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Pulse rate: <50 bpm and with >20 bpm decrease	1 Participants	0 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Pulse rate: >115 bpm and with >30 bpm increase	0 Participants	0 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Systolic BP: <90 mmHg and >30 mmHg decrease	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 60

Population: Safety analysis set included all participants who received at least 1 dose of study intervention.

Number of participants with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or 4 abnormalities in clinical laboratory tests: hematology and chemistry were reported. Clinical laboratory abnormalities of living participants were assessed as per NCI CTCAE version 5, grades (0-4), where Grade 0-Normal, Grade 1- Mild, Grade 2- Moderate, Grade 3- Severe or medically significant but not immediately life-threatening, Grade 4- Life-threatening consequences. Higher grades showed severe abnormality. As per the discretion of investigator, laboratory abnormalities with NCI CTCAE Grade 3 or 4 were considered clinically significant. Combined data of Grade 3 and 4 abnormalities are reported as planned. Only those categories in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 Participants Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Chemistry: Creatinine Increased	1 Participants	0 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Chemistry: Alanine Aminotransferase Increased	1 Participants	0 Participants
Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Hematology: Lymphocyte Count Decreased	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Pre-dose and 1 hour post dose on Week 0 (Day 1), Week 4 (Day 28), and Week 8 (Day 56); Week 12 (Day 84), Week 16 (Day 112), Week 28 (Day 196), Week 52 (Day 364)

Population: Pharmacokinetics (PK) analysis set included all participants who received at least 1 administration of Guselkumab and had at least one valid post dose blood sample drawn for PK analysis. Here, N (Overall number of participant analyzed) signifies number of participant evaluable for this outcome measure and n (number analyzed) signifies number of participants evaluable at specified timepoints. This outcome measure was planned to be analyzed for Guselkumab arm only.

Serum concentrations of Guselkumab over time was reported.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Serum Concentrations of Guselkumab Pre dose on Week 0 (Day 1)	0.00 Microgram per milliliter (mcg/mL Standard Deviation 0.000	—
Main Study: Serum Concentrations of Guselkumab 1 Hour Post Dose on Week 0 (Day 1)	130.93 Microgram per milliliter (mcg/mL Standard Deviation 45.522	—
Main Study: Serum Concentrations of Guselkumab Pre dose on Week 4 (Day 28)	11.21 Microgram per milliliter (mcg/mL Standard Deviation 6.616	—
Main Study: Serum Concentrations of Guselkumab 1 Hour Post Dose on Week 4 (Day 28)	150.21 Microgram per milliliter (mcg/mL Standard Deviation 34.952	—
Main Study: Serum Concentrations of Guselkumab Pre dose on Week 8 (Day 56)	19.71 Microgram per milliliter (mcg/mL Standard Deviation 23.002	—
Main Study: Serum Concentrations of Guselkumab 1 Hour Post Dose on Week 8 (Day 56)	127.14 Microgram per milliliter (mcg/mL Standard Deviation 68.157	—
Main Study: Serum Concentrations of Guselkumab Week 12 (Day 84)	19.16 Microgram per milliliter (mcg/mL Standard Deviation 17.831	—
Main Study: Serum Concentrations of Guselkumab Week 16 (Day 112)	15.81 Microgram per milliliter (mcg/mL Standard Deviation 9.644	—
Main Study: Serum Concentrations of Guselkumab Week 28 (Day 196)	12.63 Microgram per milliliter (mcg/mL Standard Deviation 4.824	—
Main Study: Serum Concentrations of Guselkumab Week 52 (Day 364)	12.55 Microgram per milliliter (mcg/mL Standard Deviation 4.701	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 28, Week 52

Population: Immunogenicity analysis set included all participants who received at least 1 administration of guselkumab and have at least one post-dose sample collection. This outcome measure was planned to be analyzed for Guselkumab arm only.

Number of participants with antibodies to Guselkumab were reported.

Outcome measures

Outcome measures
Measure	Main Study: Guselkumab n=35 Participants Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.
Main Study: Number of Participants With Antibodies to Guselkumab Baseline (Day 1) up to Week 28	1 Participants	—
Main Study: Number of Participants With Antibodies to Guselkumab Baseline (Day 1) up to Week 52	3 Participants	—

Adverse Events

Main Study: Guselkumab

Serious events: 6 serious events

Other events: 31 other events

Deaths: 1 deaths

Main Study: Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

LTE Period: Guselkumab

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

LTE Period: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main Study: Guselkumab n=35 participants at risk Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	Main Study: Placebo n=18 participants at risk Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60.	LTE Period: Guselkumab n=9 participants at risk At Week 48, participants from main study who were in GC-free remission and consented for the long term extension (LTE) period, continued to receive Guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Participants were then followed up for safety for 12 weeks after the last dose up to Week 112.	LTE Period: Placebo n=6 participants at risk At Week 48, participants from main study who were in GC-free remission and consented for the LTE period, continued to receive placebo matching to guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Participants were then followed up for safety for 12 weeks after the last dose up to Week 112.
Infections and infestations Abdominal Sepsis	2.9% 1/35 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/18 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/9 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/6 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.
Infections and infestations Urosepsis	2.9% 1/35 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/18 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/9 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/6 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Fractured Sacrum	2.9% 1/35 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/18 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/9 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/6 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.
Investigations Alanine Aminotransferase Increased	2.9% 1/35 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/18 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/9 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/6 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.
Investigations Aspartate Aminotransferase Increased	2.9% 1/35 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/18 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/9 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/6 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.
Renal and urinary disorders Acute Kidney Injury	2.9% 1/35 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/18 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/9 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/6 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.9% 1/35 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/18 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/9 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/6 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.
Vascular disorders Peripheral Artery Stenosis	2.9% 1/35 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/18 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/9 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.	0.00% 0/6 • Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 60) Safety analysis set included all subjects who received at least 1 dose of study intervention.

Other adverse events

Additional Information

Manager Clinical Science Translational

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