Giant Cell Arteritis
Conditions
Brief summary
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).
Detailed description
Giant cell arteritis (GCA) is a non-necrotizing granulomatous systemic vasculitis of unknown etiology affecting medium-sized and large arteries usually accompanied or preceded by systemic inflammation. Guselkumab is a monoclonal antibody (mAb) that binds to the p19 sub-unit of human interleukin (IL)-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent activation and cytokine production. It is used in treatment of psoriatic arthritis, generalized pustular psoriasis, erythrodermic psoriasis. The study consists of a screening period (less than or equal to \[\<=\] 6 weeks), double-blind treatment period (48 weeks), and safety follow-up period (12 weeks). Participants who complete the Week 52 visit and are assessed to be in glucocorticoid (GC)-free remission, may have the option to participate in the long-term extension (LTE) period of the study for up to 12 months. This study will evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of guselkumab in combination with a 26-week GC taper regimen for the treatment of active new-onset or relapsing GCA in adult participants. The total duration of the study is up to 66 weeks for the main study and for participants that continue in the LTE period, the total study duration will be up to 112 weeks.
Interventions
DRUGGuselkumab
Guselkumab will be administered subcutaneously.
DRUGPlacebo
Matching placebo will be administered subcutaneously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Giant cell arteritis (GCA) according to the revised American College of Rheumatology criteria * GCA diagnosis confirmed by either temporal artery biopsy revealing features of GCA either at time of diagnosis or at other timepoint during disease history; or evidence of cranial GCA either at time of diagnosis or at other timepoint during disease history by cranial doppler-ultrasound; or cranial Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography; or other imaging modality upon agreement with the sponsor or evidence of GCA by angiography or cross-sectional imaging (ultrasound, MRI, computed tomography \[CT\], positron emission tomography \[PET\]) * Have new onset or relapsing GCA * Have active GCA within 6 weeks of first study intervention: Active GCA: presence of signs and symptoms of GCA and elevated erythrocyte sedimentation rate (ESR) greater than or equal to (\>=) 30 millimeter per hour (mm/hour), or C-reactive protein (CRP) \>= 10 milligrams per liter (mg/L) (or 1 milligrams per deciliter \[mg/dL\]), attributed to active GCA. ESR \>= 30 mm/hour or CRP \>= 10 mg/L (or 1 mg/dL) is not required if active GCA has been confirmed by a positive temporal artery biopsy or ultrasound or other imaging modality within 6 weeks of first study intervention * Clinically stable GCA disease on a glucocorticoid (GC) dose between 20 and 60 milligrams per day (mg/day) (prednisone or equivalent) at randomization such that the participant is able to safely participate in the protocol defined prednisone taper regimen, in the opinion of the investigator
Exclusion criteria
* Has any known severe or uncontrolled GCA complications * Has any rheumatic disease other than GCA such that could interfere with assessment of GCA * Has a current diagnosis or signs or symptoms of severe, progressive, or concomitant medical condition that places the participant at risk by participating in this study) * Has or has had any major ischemic event, within 12 weeks of first study intervention. Has a personal history of arterial thrombosis or venous thromboembolism (including deep venous thrombosis \[DVT\] and Pulmonary Embolism \[PE\]) * Has any comorbidities requiring 3 or more courses of systemic GCs within 12 months of first study intervention, AND, inability, in the opinion of the investigator, to withdraw GC therapy through protocol-defined taper regimen due to suspected or established adrenal insufficiency, OR, currently on systemic chronic GC therapy for reasons other than GCA and be GC dependent and have the potential to flare due to GC tapering (e.g. unstable asthma, unstable COPD) * Has a history of, or ongoing, chronic or recurrent infectious disease * Has received within specified timeframe, or 5 half-lives (whichever is greater) , or has failed treatment with any investigational or approved biologic agents or Janus Kinase Inhibitor prior to first study intervention * Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start: Any cytotoxic agents (cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents) with 6 months; Hydroxychloroquine, cyclosporine A, azathioprine, tacrolimus, sirolimus, sulfasalazine, leflunomide with cholestyramine washout or mycophenolate mofetil/mycophenolic acid within 3 months; Intramuscular, intra-articular, intrabursal, epidural, intra-lesional or IV GCs within 6 week; and Methotrexate (MTX) within 12 weeks. If started MTX \>12 weeks prior to first study intervention MTX must have been at a stable dose for minimally 4 weeks and must not be receiving more than 25 mg oral or SC MTX per week * Has chronic continuous use of systemic GCs for greater than (\>) 4 years or inability, in the opinion of the investigator, to withdraw GC treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28 | Week 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main Study: Cumulative Glucocorticoid (GC) Dose | Baseline (Day 1) up to Weeks 28 and 52 | 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. |
| 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 | Weeks 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | Weeks 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 | Weeks 28, 32, 36, 40, 44, 48 and 52 | 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. |
| 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 and Week 52 | 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. |
| Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA | Baseline (Day 1) up to Week 30 and Week 52 | 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. |
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | 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. |
| Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Baseline (Day 1) up to Week 60 | 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. |
| Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs) | Baseline (Day 1) up to Week 60 | 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. |
| Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Baseline (Day 1) up to Week 60 | 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. |
| Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Baseline (Day 1) up to Week 60 | 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. |
| Main Study: Serum Concentrations of Guselkumab | 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) | Serum concentrations of Guselkumab over time was reported. |
| Main Study: Number of Participants With Antibodies to Guselkumab | Baseline (Day 1) up to Week 28, Week 52 | Number of participants with antibodies to Guselkumab were reported. |
| Main Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline (Day 1) up to Week 60 | 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. |
Countries
Belgium, Canada, France, Germany, Israel, Italy, Poland, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 18 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| LTE Period (Week 52 up to Week 112) | Adverse Event | 1 | 1 |
| LTE Period (Week 52 up to Week 112) | Study Terminated by Sponsor | 3 | 2 |
| Main Study (From Week 0 up to Week 60) | Adverse Event | 8 | 2 |
| Main Study (From Week 0 up to Week 60) | Physician Decision | 0 | 1 |
| Main Study (From Week 0 up to Week 60) | Study terminated by sponsor | 3 | 3 |
| Main Study (From Week 0 up to Week 60) | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Guselkumab | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 44 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 9 Participants | 3 Participants |
| Age, Continuous | 71.9 years STANDARD_DEVIATION 7.65 | 71.5 years STANDARD_DEVIATION 7.43 | 70.8 years STANDARD_DEVIATION 7.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 11 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 42 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 53 Participants | 18 Participants |
| Region of Enrollment Belgium | 4 Participants | 4 Participants | 0 Participants |
| Region of Enrollment Canada | 8 Participants | 12 Participants | 4 Participants |
| Region of Enrollment France | 3 Participants | 3 Participants | 0 Participants |
| Region of Enrollment Germany | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment Israel | 3 Participants | 4 Participants | 1 Participants |
| Region of Enrollment Italy | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment Poland | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment Spain | 8 Participants | 13 Participants | 5 Participants |
| Sex: Female, Male Female | 25 Participants | 37 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 35 | 0 / 18 | 0 / 9 | 0 / 6 |
| other Total, other adverse events | 31 / 35 | 17 / 18 | 6 / 9 | 5 / 6 |
| serious Total, serious adverse events | 6 / 35 | 0 / 18 | 0 / 9 | 0 / 6 |
Outcome results
Primary
Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28
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.
Time frame: Week 28
Population: Full analysis set (FAS) included all randomized participants who received at least 1 administration of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study: Guselkumab | Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28 | 40.0 Percentage of Participants |
| Main Study: Placebo | Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28 | 33.3 Percentage of Participants |
p-value: =0.63890% CI: [-14.7, 27.9]Cochran-Mantel-Haenszel
Secondary
Main Study: Cumulative Glucocorticoid (GC) Dose
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.
Time frame: Baseline (Day 1) up to Weeks 28 and 52
Population: FAS included all randomized participants who received at least 1 administration of study intervention.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study: Guselkumab | Main Study: Cumulative Glucocorticoid (GC) Dose | Baseline (Day 1) up to Week 28 | 2231.0 Milligrams (mg) |
| Main Study: Guselkumab | Main Study: Cumulative Glucocorticoid (GC) Dose | Baseline (Day 1) up to Week 52 | 2418.5 Milligrams (mg) |
| Main Study: Placebo | Main Study: Cumulative Glucocorticoid (GC) Dose | Baseline (Day 1) up to Week 52 | 2902.1 Milligrams (mg) |
| Main Study: Placebo | Main Study: Cumulative Glucocorticoid (GC) Dose | Baseline (Day 1) up to Week 28 | 2205.0 Milligrams (mg) |
Secondary
Main Study: Number of Participants With Antibodies to Guselkumab
Number of participants with antibodies to Guselkumab were reported.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: Guselkumab | Main Study: Number of Participants With Antibodies to Guselkumab | Baseline (Day 1) up to Week 28 | 1 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Antibodies to Guselkumab | Baseline (Day 1) up to Week 52 | 3 Participants |
Secondary
Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
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.
Time frame: Baseline (Day 1) up to Week 60
Population: Safety analysis set included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Chemistry: Creatinine Increased | 1 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Chemistry: Alanine Aminotransferase Increased | 1 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Hematology: Lymphocyte Count Decreased | 3 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Chemistry: Creatinine Increased | 0 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Chemistry: Alanine Aminotransferase Increased | 0 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Hematology: Lymphocyte Count Decreased | 3 Participants |
Secondary
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Systolic BP: >150 mmHg and >40 mmHg increase | 0 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Interarm BP:BP difference >=15 mmHg in systolic BP | 2 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Systolic BP: <90 mmHg and >30 mmHg decrease | 2 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temp: >38.4 C and >=1 C increase from baseline | 0 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Diastolic BP: <50 mmHg and >20 mmHg decrease | 2 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Weight: Decrease 10% from baseline | 0 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Pulse rate: >115 bpm and with >30 bpm increase | 0 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Weight: Increase 10% from baseline | 6 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Diastolic BP: >95 mmHg and >30 mmHg increase | 1 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate: >20 breaths per minute | 1 Participants |
| Main Study: Guselkumab | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Pulse rate: <50 bpm and with >20 bpm decrease | 1 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate: >20 breaths per minute | 4 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Pulse rate: <50 bpm and with >20 bpm decrease | 0 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Pulse rate: >115 bpm and with >30 bpm increase | 0 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Systolic BP: <90 mmHg and >30 mmHg decrease | 0 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Systolic BP: >150 mmHg and >40 mmHg increase | 2 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Diastolic BP: <50 mmHg and >20 mmHg decrease | 0 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Diastolic BP: >95 mmHg and >30 mmHg increase | 1 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Interarm BP:BP difference >=15 mmHg in systolic BP | 2 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temp: >38.4 C and >=1 C increase from baseline | 0 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Weight: Decrease 10% from baseline | 1 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Weight: Increase 10% from baseline | 2 Participants |
Secondary
Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Placebo | 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 | 8 Participants |
| Main Study: Placebo | 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 |
| Main Study: Placebo | 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 |
| Main Study: Placebo | 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 | 7 Participants |
| Main Study: Placebo | 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 |
| Main Study: Placebo | 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 |
Secondary
Main Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: Baseline (Day 1) up to Week 60
Population: Safety analysis set included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: Guselkumab | Main Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 34 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 17 Participants |
Secondary
Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs)
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.
Time frame: Baseline (Day 1) up to Week 60
Population: Safety analysis set included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: Guselkumab | Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs) | 6 Participants |
| Main Study: Placebo | Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs) | 0 Participants |
Secondary
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
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.
Time frame: Weeks 28, 32, 36, 40, 44, 48 and 52
Population: FAS included all randomized participants who received at least 1 administration of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Placebo | 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 | 16.7 Percentage of Participants |
| Main Study: Placebo | 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 | 11.1 Percentage of Participants |
| Main Study: Placebo | 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 | 16.7 Percentage of Participants |
| Main Study: Placebo | 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 | 16.7 Percentage of Participants |
| Main Study: Placebo | 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 | 11.1 Percentage of Participants |
| Main Study: Placebo | 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 | 5.6 Percentage of Participants |
| Main Study: Placebo | 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 | 22.2 Percentage of Participants |
Secondary
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
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.
Time frame: Weeks 28, 32, 36, 40, 44, 48 and 52
Population: FAS included all randomized participants who received at least 1 administration of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Placebo | 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 | 22.2 Percentage of Participants |
| Main Study: Placebo | 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 | 16.7 Percentage of Participants |
| Main Study: Placebo | 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 | 16.7 Percentage of Participants |
| Main Study: Placebo | 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 | 22.2 Percentage of Participants |
| Main Study: Placebo | 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 | 33.3 Percentage of Participants |
| Main Study: Placebo | 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 | 27.8 Percentage of Participants |
| Main Study: Placebo | 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 | 27.8 Percentage of Participants |
Secondary
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
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.
Time frame: Weeks 28, 32, 36, 40, 44, 48 and 52
Population: FAS included all randomized participants who received at least 1 administration of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Placebo | 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 | 22.2 Percentage of Participants |
| Main Study: Placebo | 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 | 16.7 Percentage of Participants |
| Main Study: Placebo | 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 | 16.7 Percentage of Participants |
| Main Study: Placebo | 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 | 11.1 Percentage of Participants |
| Main Study: Placebo | 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 | 16.7 Percentage of Participants |
| Main Study: Placebo | 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 | 5.6 Percentage of Participants |
| Main Study: Placebo | 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 | 11.1 Percentage of Participants |
Secondary
Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52
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.
Time frame: Weeks 28, 32, 36, 40, 44, 48 and 52
Population: FAS included all randomized participants who received at least 1 administration of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Placebo | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | At Week 52 | 27.8 Percentage of Participants |
| Main Study: Placebo | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | At Week 28 | 33.3 Percentage of Participants |
| Main Study: Placebo | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | At Week 32 | 33.3 Percentage of Participants |
| Main Study: Placebo | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | At Week 36 | 33.3 Percentage of Participants |
| Main Study: Placebo | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | At Week 40 | 33.3 Percentage of Participants |
| Main Study: Placebo | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | At Week 44 | 33.3 Percentage of Participants |
| Main Study: Placebo | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | At Week 48 | 27.8 Percentage of Participants |
Secondary
Main Study: Serum Concentrations of Guselkumab
Serum concentrations of Guselkumab over time was reported.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Guselkumab | Main Study: Serum Concentrations of Guselkumab | Pre dose on Week 0 (Day 1) | 0.00 Microgram per milliliter (mcg/mL | Standard Deviation 0 |
| Main Study: Guselkumab | 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: Guselkumab | 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: Guselkumab | 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: Guselkumab | 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: Guselkumab | 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: Guselkumab | Main Study: Serum Concentrations of Guselkumab | Week 12 (Day 84) | 19.16 Microgram per milliliter (mcg/mL | Standard Deviation 17.831 |
| Main Study: Guselkumab | Main Study: Serum Concentrations of Guselkumab | Week 16 (Day 112) | 15.81 Microgram per milliliter (mcg/mL | Standard Deviation 9.644 |
| Main Study: Guselkumab | Main Study: Serum Concentrations of Guselkumab | Week 28 (Day 196) | 12.63 Microgram per milliliter (mcg/mL | Standard Deviation 4.824 |
| Main Study: Guselkumab | Main Study: Serum Concentrations of Guselkumab | Week 52 (Day 364) | 12.55 Microgram per milliliter (mcg/mL | Standard Deviation 4.701 |
Secondary
Main Study: Time to First GCA Disease Flare or Discontinuation of Study Intervention Due to Adverse Event (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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Placebo | 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 | 29.71 Weeks |
| Main Study: Placebo | 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 | 30.07 Weeks |
Secondary
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More
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.
Time frame: Baseline (Day 1) up to Week 60
Population: Safety analysis set included all participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Gastrointestinal disorders | 10 Participants |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Infections and infestations | 21 Participants |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Vascular disorders | 18 Participants |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Nervous system disorders | 9 Participants |
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Eye disorders | 8 Participants |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Investigations | 6 Participants |
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Endocrine disorders | 5 Participants |
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Psychiatric disorders | 4 Participants |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | 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 |
| Main Study: Guselkumab | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Cardiac disorders | 2 Participants |
| Main Study: Guselkumab | 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 |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Cardiac disorders | 2 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Nervous system disorders | 9 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Investigations | 0 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Skin and subcutaneous tissue disorders | 1 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Metabolism and nutrition disorders | 1 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Infections and infestations | 11 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Injury, poisoning and procedural complications | 2 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Musculoskeletal and connective tissue disorders | 5 Participants |
| Main Study: Placebo | 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 |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Vascular disorders | 11 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Gastrointestinal disorders | 2 Participants |
| Main Study: Placebo | 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) | 1 Participants |
| Main Study: Placebo | 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 | 6 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Endocrine disorders | 0 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Renal and urinary disorders | 1 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Eye disorders | 3 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Psychiatric disorders | 1 Participants |
| Main Study: Placebo | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Respiratory, thoracic and mediastinal disorders | 4 Participants |