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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959GCA2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-000622-26 | EudraCT Number |
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The study primary endpoint was not met
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guselkumab | Experimental | Participants will receive guselkumab subcutaneously (SC) every 4 weeks from Week 0 through Wweek 48. This will be in combination with a protocol specified 26-week GC taper. Participants of the long-term extension (LTE) period will continue to receive subcutaneous (SC) injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a Giant cell arteritis (GCA) flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first. |
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| Placebo | Experimental | Participants will receive matching placebo SC every 4 weeks from Week 0 through Week 48. This will be in combination with a protocol-specified 26-week GC taper. Participants of the LTE period will continue to receive SC injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a GCA flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| Massachusetts General Hospital |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Study (From Week 0 up to Week 60) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2022 | May 19, 2025 |
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| Placebo | Drug | Matching placebo will be administered subcutaneously. |
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| Weeks 28, 32, 36, 40, 44, 48 and 52 |
| 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. | Weeks 28, 32, 36, 40, 44, 48 and 52 |
| 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. | Weeks 28, 32, 36, 40, 44, 48 and 52 |
| 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. | Weeks 28, 32, 36, 40, 44, 48 and 52 |
| 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. | Baseline (Day 1) up to Weeks 28 and 52 |
| 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. | Baseline (Day 1) up to Week 30 and Week 52 |
| 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. | Baseline (Day 1) up to Week 30 and Week 52 |
| 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. | Baseline (Day 1) up to Week 60 |
| 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. | Baseline (Day 1) up to Week 60 |
| 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. | Baseline (Day 1) up to Week 60 |
| 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. | Baseline (Day 1) up to Week 60 |
| 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. | Baseline (Day 1) up to Week 60 |
| Main Study: Serum Concentrations of Guselkumab | Serum concentrations of Guselkumab over time was reported. | 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) |
| Main Study: Number of Participants With Antibodies to Guselkumab | Number of participants with antibodies to Guselkumab were reported. | Baseline (Day 1) up to Week 28, Week 52 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Mount Sinai Hospital | Toronto | Ontario | M5T 3L9 | Canada |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| CHU Dijon | Dijon | 21000 | France |
| Hopital Cochin | Paris | 75014 | France |
| Universitatsklinikum Erlangen | Erlangen | 91054 | Germany |
| medius KLINIK KIRCHHEIM | Kirchheim unter Teck | 73230 | Germany |
| Universitatsklinik Tubingen | Tübingen | 72076 | Germany |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Rabin Medical Center Beilinson Campus | Petah Tikva | 49100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico | Bolzano | 39100 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35121 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Azienda USL 4 Prato | Prato | 59100 | Italy |
| ASUI Santa Maria della Misericordia di Udine | Udine | 33100 | Italy |
| Szpital Uniwersytecki Nr 2 w Bydgoszczy | Bydgoszcz | 85 168 | Poland |
| Szpital Specjalistyczny im. J. Dietla | Krakow | 31-121 | Poland |
| NZOZ Lecznica MAK MED S C | Nadarzyn | 05 830 | Poland |
| Hosp Univ A Coruna | A Coruña | 15006 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp Regional Univ de Malaga | Málaga | 29009 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| FG001 | 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. |
| Participants Enrolled Post PA-5 Who Received Placebo Matching to Guselkumab 200 mg From Week 0 |
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| Participants Enrolled Post PA-5 Who Received Guselkumab 200 mg From Week 0 |
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| COMPLETED |
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| NOT COMPLETED |
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| LTE Period (Week 52 up to Week 112) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Full analysis set (FAS) included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of Participants | Week 28 |
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| 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. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of Participants | Weeks 28, 32, 36, 40, 44, 48 and 52 |
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| 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. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of Participants | Weeks 28, 32, 36, 40, 44, 48 and 52 |
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| 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. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of Participants | Weeks 28, 32, 36, 40, 44, 48 and 52 |
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| 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. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Number | Percentage of Participants | Weeks 28, 32, 36, 40, 44, 48 and 52 |
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| 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. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Median | Full Range | Milligrams (mg) | Baseline (Day 1) up to Weeks 28 and 52 |
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| 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. | 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. | Posted | Median | 90% Confidence Interval | Weeks | Baseline (Day 1) up to Week 30 and Week 52 |
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| 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. | FAS included all randomized participants who received at least 1 administration of study intervention. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Week 30 and Week 52 |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Week 60 |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Week 60 |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Week 60 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Count of Participants | Participants | Baseline (Day 1) up to Week 60 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Week 60 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Main Study: Serum Concentrations of Guselkumab | Serum concentrations of Guselkumab over time was reported. | 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. | Posted | Mean | Standard Deviation | Microgram per milliliter (mcg/mL | 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) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Main Study: Number of Participants With Antibodies to Guselkumab | Number of participants with antibodies to Guselkumab were reported. | 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. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Week 28, Week 52 |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Study: Guselkumab | 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. | 1 | 35 | 6 | 35 | 31 | 35 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 17 | 18 |
| EG002 | LTE Period: Guselkumab | 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. | 0 | 9 | 0 | 9 | 6 | 9 |
| EG003 | LTE Period: Placebo | 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. | 0 | 6 | 0 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Sepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fractured Sacrum | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Peripheral Artery Stenosis | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocarditis | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cataract Nuclear | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Macular Degeneration | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Visual Field Defect | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Abdominal Mass | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Complication Associated with Device | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Acute Sinusitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tinea Pedis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Greater Trochanteric Pain Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Polymyalgia Rheumatica | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Brain Fog | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haemorrhage Urinary Tract | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Vulvovaginal Discomfort | Reproductive system and breast disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nasal Polyps | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tonsillar Hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Skin Fragility | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Giant Cell Arteritis | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Clinical Science Translational | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2023 | May 19, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000588857 | guselkumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| France |
|
| Germany |
|
| Israel |
|
| Italy |
|
| Poland |
|
| Spain |
|
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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
|
|
| OG001 | 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. |
|
|
|
|
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: 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. |
|
|
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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|