Scleroderma, Systemic
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).
Interventions
Guselkumab Dose 1 will be administered intravenously.
Guselkumab Dose 2 will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered intravenously or subcutaneously.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of systemic sclerosis (SSc) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria * Diffuse cutaneous SSc according to the LeRoy criteria that is, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis * Disease duration of ≤36 months (defined as time from first non-Raynaud phenomenon manifestation). * Greater than or equal to (\>=) 10 and less than or equal to (\<=) 22 modified Rodnan skin score (mRSS) units at screening and Week 0 * Forced vital capacity (FVC) \>= 60 percent (%) of predicted at screening * Diffusing capacity of the lung for carbon monoxide (DLCO) \>= 40% of predicted (hemoglobin-corrected) at screening. * Participants who meet 1 of the following criteria at screening: increase of \>=3 mRSS units, compared with an assessment performed within the previous 2 to 6 months; Involvement of 1 new body area with an increase of \>=2 mRSS units compared with an assessment performed within the previous 2 to 6 months; and Involvement of 2 new body areas with increase of \>=1 mRSS units compared with the assessment within the previous 2 to 6 months
Exclusion criteria
* History of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute \[mL/min\]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * Has any known severe or uncontrolled SSc complications including hemoptysis, pulmonary hemorrhage, renal crisis * Has an interstitial lung disease requiring oxygen therapy * Has any rheumatic disease other than SSc such as rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), systemic lupus erythematosus, polymyositis/dermatomyositis that could interfere with assessment of SSc * Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | Baseline and Week 24 | Change from baseline in mRSS at Week 24 was reported. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52 | Week 24 and Week 52 | The percentage of participants who experienced worsening of mRSS at Week 24 and Week 52 was reported. The worsening of mRSS was defined as an increase from baseline greater than or equal to (\>=) 5 points and \>=20 percent (%) in mRSS. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. |
| Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52 | Week 24 and Week 52 | ACR CRISS is a composite endpoint. Firstly, participants were evaluated on not-improved criterion: new onset of renal crisis, \>=15% decline in forced vital capacity \[FVC\] percent predicted relative to baseline, new onset of pulmonary arterial hypertension, and new onset of left ventricular failure. If yes, these participants were assigned probability score of 0.0. For remaining participants, percentage was based on CRISS domains: mRSS, FVC percent predicted, physician's global assessment, patient's global assessment and Health Assessment Questionnaire Disability-Index (HAQ-DI). Algorithm determines predicted probability of improvement from baseline by incorporating change in mRSS, FVC percent predicted, physician and patient global assessments and HAQ-DI. Outcome was a continuous variable between 0.0 and 1.0 (0 to 100%). Higher score=greater probability of improvement. ACR CRISS score \>=0.60 was considered improved, while predicted probability below 0.60 was considered not improved. |
| Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52 | Baseline, Week 24 and Week 52 | FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying interstitial lung disease. |
| Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52 | Baseline, Week 24 and Week 52 | Change from baseline in the percent predicted FVC at Week 24 and Week 52 was reported. FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying interstitial lung disease. |
| Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Baseline, Week 24 and Week 52 | DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. DLCO is measured using the single breath method. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath. |
| Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Baseline, Week 24 and Week 52 | Change from baseline in the percent predicted DLCO at Week 24 and Week 52 was reported. DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. DLCO is measured using the single breath method. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath. |
| Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52 | Baseline, Week 24 and Week 52 | Digital ulcers were defined as a full thickness (\>3 millimeters \[mm\] in maximal diameter) skin lesion with loss of epithelium including lesions covered by eschar (excluding pitting scars and hyperkeratotic lesions). Healing was defined by re-epithelialization with loss of pain and exudate. The digital ulcer assessments and counting were performed by the investigator designee. |
| Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52 | Baseline, Week 24 and Week 52 | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during past week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each activity category consisted of 2-3 items. For each item, level of difficulty was scored from 0 to 3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Total HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability. |
| Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52 | From Baseline (Week 0) up to Week 24 and Week 52 | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs that occur at or after the initial administration of study intervention. All TEAEs including serious and non-serious events are reported in this outcome measure. |
| Main Study: Change From Baseline in Modified Rodnan Skin Score at Week 52 | Baseline and Week 52 | Change from baseline in mRSS at Week 52 was reported. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. |
| Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52 | From Baseline (Week 0) up to Week 24 and Week 52 | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, or resulted in congenital anomaly/birth defect. TEAEs were defined as AEs that occur at or after the initial administration of study intervention. |
| Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From Week 52 up to Week 112 | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, or resulted in congenital anomaly/birth defect. TEAEs were defined as AEs that occur at or after the initial administration of study intervention. |
| Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52 | From Baseline (Week 0) up to Week 24 and Week 52 | AESI were defined as any newly identified malignancy or case of active tuberculosis (TB) or interstitial lung disease (ILD) occurring after the first study intervention administration in study participants and was reported by the investigator to the sponsor or designee within 24 hours after being made aware of the event. AESIs for this study included drug-induced liver injuries, active TB, ILD, hypersensitivity reaction, opportunistic infection and adverse cardiovascular events. |
| Long-term Extension (LTE) Period: Number of Participants With Adverse Events of Special Interest (AESI) | From Week 52 up to Week 112 | AESI were defined as any newly identified malignancy or case of active tuberculosis (TB) or interstitial lung disease (ILD) occurring after the first study intervention administration in study participants and was reported by the investigator to the sponsor or designee within 24 hours after being made aware of the event. AESIs for this study included drug-induced liver injuries, active TB, ILD, hypersensitivity reaction, opportunistic infection and adverse cardiovascular events. |
| Main Study: Serum Concentration of Guselkumab | Pre-dose at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Post- dose at Weeks 0, 4, 8 | Serum concentration of guselkumab was reported. The lower limit of quantification (LLOQ) for guselkumab was 0.01 micrograms per milliliter (mcg/mL). |
| Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose (at Weeks 56, 60, 64, 76, 88, 96) and Week 104 | Serum concentration of guselkumab was reported. The LLOQ for guselkumab was 0.01 mcg/mL. |
| Main Study: Number of Participants With Anti-Guselkumab Antibody | From Baseline (Week 0) up to Week 52 | Number of participants with anti-guselkumab antibody were reported. Serum samples were assessed for anti-drug antibodies. |
| Long-term Extension (LTE) Study: Number of Participants With Anti-guselkumab Antibody | From Week 52 up to Week 104 | Number of participants with anti-guselkumab antibody were reported. Serum samples were assessed for anti-drug antibodies. |
| Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From Week 52 up to Week 112 | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs that occurred at or after the initial administration of study intervention. All TEAEs including serious and non-serious events are reported in this outcome measure. |
Countries
Japan
Participant flow
Recruitment details
Participants diagnosed with systemic sclerosis as per American College of Rheumatology and European League Against Rheumatism 2013 criteria with disease duration of less than or equal to (\<=) 36 months and Modified Rodnan Skin Score ranged from greater than or equal to (\>=) 10 to less than or equal to (\<=) 22 units were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Main Study: Group A: Guselkumab Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60. | 29 |
| Main Study: Group B: Placebo Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60. | 27 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Long-term Extension(LTE):Week52-Week 112 | Death | 0 | 0 | 1 | 0 |
| Long-term Extension(LTE):Week52-Week 112 | Withdrawal by Subject | 0 | 0 | 0 | 2 |
| Main Study: Week 0-Week 60 | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Main Study: Group B: Placebo | Main Study: Group A: Guselkumab | Total |
|---|---|---|---|
| Age, Continuous | 50.8 Years STANDARD_DEVIATION 12.18 | 51.3 Years STANDARD_DEVIATION 13.26 | 51.1 Years STANDARD_DEVIATION 12.64 |
| Age, Customized 18 to 64 years | 23 Participants | 25 Participants | 48 Participants |
| Age, Customized 65 years and over | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 28 Participants | 55 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 | 27 Participants | 28 Participants | 55 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment JAPAN | 27 Participants | 29 Participants | 56 Participants |
| Sex: Female, Male Female | 21 Participants | 26 Participants | 47 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 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 | 0 / 29 | 0 / 27 | 1 / 25 | 0 / 26 |
| other Total, other adverse events | 22 / 29 | 26 / 27 | 22 / 25 | 22 / 26 |
| serious Total, serious adverse events | 1 / 29 | 1 / 27 | 1 / 25 | 0 / 26 |
Outcome results
Primary
Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
Change from baseline in mRSS at Week 24 was reported. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome.
Time frame: Baseline and Week 24
Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | -9.5 Score on a scale | Standard Error 0.74 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | 3.1 Score on a scale | Standard Error 0.77 |
p-value: <0.00180% CI: [-13.8, -11.4]MMRM model
Secondary
Long-term Extension (LTE) Period: Number of Participants With Adverse Events of Special Interest (AESI)
AESI were defined as any newly identified malignancy or case of active tuberculosis (TB) or interstitial lung disease (ILD) occurring after the first study intervention administration in study participants and was reported by the investigator to the sponsor or designee within 24 hours after being made aware of the event. AESIs for this study included drug-induced liver injuries, active TB, ILD, hypersensitivity reaction, opportunistic infection and adverse cardiovascular events.
Time frame: From Week 52 up to Week 112
Population: The safety analysis set for LTE period included all randomized participants who received at least 1 dose (complete or partial) of study intervention during LTE period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Period: Number of Participants With Adverse Events of Special Interest (AESI) | 0 Participants |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Period: Number of Participants With Adverse Events of Special Interest (AESI) | 0 Participants |
Secondary
Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs that occurred at or after the initial administration of study intervention. All TEAEs including serious and non-serious events are reported in this outcome measure.
Time frame: From Week 52 up to Week 112
Population: The safety analysis set for LTE period included all randomized participants who received at least 1 dose (complete or partial) of study intervention during LTE period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 23 Participants |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 25 Participants |
Secondary
Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, or resulted in congenital anomaly/birth defect. TEAEs were defined as AEs that occur at or after the initial administration of study intervention.
Time frame: From Week 52 up to Week 112
Population: The safety analysis set for LTE period included all randomized participants who received at least 1 dose (complete or partial) of study intervention during LTE period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 1 Participants |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 0 Participants |
Secondary
Long-term Extension (LTE) Study: Number of Participants With Anti-guselkumab Antibody
Number of participants with anti-guselkumab antibody were reported. Serum samples were assessed for anti-drug antibodies.
Time frame: From Week 52 up to Week 104
Population: Immunogenicity analysis set included all participants who received at least 1 administration of guselkumab and had at least 1 observed post dose immune response data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Study: Number of Participants With Anti-guselkumab Antibody | 6 Participants |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Study: Number of Participants With Anti-guselkumab Antibody | 0 Participants |
Secondary
Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab
Serum concentration of guselkumab was reported. The LLOQ for guselkumab was 0.01 mcg/mL.
Time frame: Pre-dose (at Weeks 56, 60, 64, 76, 88, 96) and Week 104
Population: Pharmacokinetics analysis set included all participants who received at least 1 complete administration of guselkumab and had at least 1 observed post dose PK data. Here, 'n' (number analyzed) refers to participants analyzed at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 88 | 10.339 mcg/mL | Standard Deviation 5.1209 |
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 96 | 10.082 mcg/mL | Standard Deviation 4.5371 |
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Week 104 | 10.080 mcg/mL | Standard Deviation 5.2596 |
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 56 | 12.167 mcg/mL | Standard Deviation 5.4753 |
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 60 | 12.704 mcg/mL | Standard Deviation 5.6942 |
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 64 | 13.835 mcg/mL | Standard Deviation 7.3326 |
| Main Study: Group A: Guselkumab | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 76 | 11.641 mcg/mL | Standard Deviation 5.5746 |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 88 | 11.893 mcg/mL | Standard Deviation 6.3203 |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 60 | 25.925 mcg/mL | Standard Deviation 10.9856 |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 96 | 12.426 mcg/mL | Standard Deviation 5.6925 |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 76 | 13.200 mcg/mL | Standard Deviation 6.081 |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Week 104 | 12.301 mcg/mL | Standard Deviation 6.0099 |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 64 | 33.368 mcg/mL | Standard Deviation 14.8075 |
| Main Study: Group B: Placebo | Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Pre-dose at Week 56 | 19.285 mcg/mL | Standard Deviation 8.3377 |
Secondary
Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52
Digital ulcers were defined as a full thickness (\>3 millimeters \[mm\] in maximal diameter) skin lesion with loss of epithelium including lesions covered by eschar (excluding pitting scars and hyperkeratotic lesions). Healing was defined by re-epithelialization with loss of pain and exudate. The digital ulcer assessments and counting were performed by the investigator designee.
Time frame: Baseline, Week 24 and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52 | Week 52 | -0.1 Ulcers | Standard Error 0.55 |
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52 | Week 24 | -0.0 Ulcers | Standard Error 0.47 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52 | Week 24 | 4.8 Ulcers | Standard Error 0.48 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52 | Week 52 | 4.1 Ulcers | Standard Error 0.58 |
Comparison: Week 2480% CI: [-5.7, -4]
Comparison: Week 5280% CI: [-5.1, -3.5]
Secondary
Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52
FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying interstitial lung disease.
Time frame: Baseline, Week 24 and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52 | Week 24 | -51.9 Liters | Standard Error 33.91 |
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52 | Week 52 | -26.5 Liters | Standard Error 30.42 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52 | Week 24 | -4.7 Liters | Standard Error 35.78 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52 | Week 52 | -12.3 Liters | Standard Error 32.15 |
Comparison: Week 2480% CI: [-96.8, 2.4]
Comparison: Week 5280% CI: [-57.2, 28.8]
Secondary
Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during past week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each activity category consisted of 2-3 items. For each item, level of difficulty was scored from 0 to 3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Total HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability.
Time frame: Baseline, Week 24 and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52 | Week 24 | -0.0529 Score on a scale | Standard Error 0.09062 |
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52 | Week 52 | -0.0572 Score on a scale | Standard Error 0.08955 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52 | Week 24 | 0.3477 Score on a scale | Standard Error 0.09439 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52 | Week 52 | 0.1782 Score on a scale | Standard Error 0.09321 |
Comparison: Week 2480% CI: [-0.5344, -0.2668]
Comparison: Week 5280% CI: [-0.373, -0.098]
Secondary
Main Study: Change From Baseline in Modified Rodnan Skin Score at Week 52
Change from baseline in mRSS at Week 52 was reported. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome.
Time frame: Baseline and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Modified Rodnan Skin Score at Week 52 | -9.3 Score on a scale | Standard Error 0.89 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Modified Rodnan Skin Score at Week 52 | 2.7 Score on a scale | Standard Error 0.93 |
80% CI: [-13.3, -10.7]
Secondary
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52
Change from baseline in the percent predicted FVC at Week 24 and Week 52 was reported. FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying interstitial lung disease.
Time frame: Baseline, Week 24 and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52 | Week 24 | -0.7 Percent predicted FVC | Standard Error 1.21 |
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52 | Week 52 | -0.2 Percent predicted FVC | Standard Error 1.17 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52 | Week 24 | -0.7 Percent predicted FVC | Standard Error 1.26 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52 | Week 52 | -0.4 Percent predicted FVC | Standard Error 1.22 |
Comparison: Week 2480% CI: [-1.7, 1.6]
Comparison: Week 5280% CI: [-1.4, 1.7]
Secondary
Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52
DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. DLCO is measured using the single breath method. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath.
Time frame: Baseline, Week 24 and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Week 24 | -0.60 Milliliter/minute/millimeter mercury | Standard Error 0.257 |
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Week 52 | -0.35 Milliliter/minute/millimeter mercury | Standard Error 0.316 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Week 24 | -0.51 Milliliter/minute/millimeter mercury | Standard Error 0.265 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Week 52 | -0.56 Milliliter/minute/millimeter mercury | Standard Error 0.327 |
Comparison: Week 2480% CI: [-0.44, 0.27]
Comparison: Week 5280% CI: [-0.29, 0.71]
Secondary
Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52
Change from baseline in the percent predicted DLCO at Week 24 and Week 52 was reported. DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. DLCO is measured using the single breath method. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath.
Time frame: Baseline, Week 24 and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Week 24 | -4.57 Percent predicted DLCO | Standard Error 1.338 |
| Main Study: Group A: Guselkumab | Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Week 52 | -1.71 Percent predicted DLCO | Standard Error 1.541 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Week 24 | -2.49 Percent predicted DLCO | Standard Error 1.347 |
| Main Study: Group B: Placebo | Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 | Week 52 | -1.85 Percent predicted DLCO | Standard Error 1.565 |
Comparison: Week 2480% CI: [-3.81, -0.34]
Comparison: Week 5280% CI: [-2.13, 2.42]
Secondary
Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52
AESI were defined as any newly identified malignancy or case of active tuberculosis (TB) or interstitial lung disease (ILD) occurring after the first study intervention administration in study participants and was reported by the investigator to the sponsor or designee within 24 hours after being made aware of the event. AESIs for this study included drug-induced liver injuries, active TB, ILD, hypersensitivity reaction, opportunistic infection and adverse cardiovascular events.
Time frame: From Baseline (Week 0) up to Week 24 and Week 52
Population: The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention. Participants were analyzed based on the intervention they received, regardless of the intervention groups to which they were assigned.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52 | Week 24 | 0 Participants |
| Main Study: Group A: Guselkumab | Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52 | Week 52 | 1 Participants |
| Main Study: Group B: Placebo | Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52 | Week 24 | 0 Participants |
| Main Study: Group B: Placebo | Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52 | Week 52 | 2 Participants |
Secondary
Main Study: Number of Participants With Anti-Guselkumab Antibody
Number of participants with anti-guselkumab antibody were reported. Serum samples were assessed for anti-drug antibodies.
Time frame: From Baseline (Week 0) up to Week 52
Population: Immunogenicity analysis set included all participants who received at least 1 administration of guselkumab and had at least 1 observed post dose immune response data. This outcome measure was planned to be analyzed for specified arm only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Number of Participants With Anti-Guselkumab Antibody | 6 Participants |
Secondary
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs that occur at or after the initial administration of study intervention. All TEAEs including serious and non-serious events are reported in this outcome measure.
Time frame: From Baseline (Week 0) up to Week 24 and Week 52
Population: The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention. Participants were analyzed based on the intervention they received, regardless of the intervention groups to which they were assigned.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52 | Week 24 | 20 Participants |
| Main Study: Group A: Guselkumab | Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52 | Week 52 | 25 Participants |
| Main Study: Group B: Placebo | Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52 | Week 24 | 24 Participants |
| Main Study: Group B: Placebo | Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52 | Week 52 | 26 Participants |
Secondary
Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, or resulted in congenital anomaly/birth defect. TEAEs were defined as AEs that occur at or after the initial administration of study intervention.
Time frame: From Baseline (Week 0) up to Week 24 and Week 52
Population: The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention. Participants were analyzed based on the intervention they received, regardless of the intervention groups to which they were assigned.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52 | Week 24 | 0 Participants |
| Main Study: Group A: Guselkumab | Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52 | Week 52 | 1 Participants |
| Main Study: Group B: Placebo | Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52 | Week 24 | 0 Participants |
| Main Study: Group B: Placebo | Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52 | Week 52 | 1 Participants |
Secondary
Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52
ACR CRISS is a composite endpoint. Firstly, participants were evaluated on not-improved criterion: new onset of renal crisis, \>=15% decline in forced vital capacity \[FVC\] percent predicted relative to baseline, new onset of pulmonary arterial hypertension, and new onset of left ventricular failure. If yes, these participants were assigned probability score of 0.0. For remaining participants, percentage was based on CRISS domains: mRSS, FVC percent predicted, physician's global assessment, patient's global assessment and Health Assessment Questionnaire Disability-Index (HAQ-DI). Algorithm determines predicted probability of improvement from baseline by incorporating change in mRSS, FVC percent predicted, physician and patient global assessments and HAQ-DI. Outcome was a continuous variable between 0.0 and 1.0 (0 to 100%). Higher score=greater probability of improvement. ACR CRISS score \>=0.60 was considered improved, while predicted probability below 0.60 was considered not improved.
Time frame: Week 24 and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52 | Week 24 | 86.2 Percentage of participants |
| Main Study: Group A: Guselkumab | Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52 | Week 52 | 79.3 Percentage of participants |
| Main Study: Group B: Placebo | Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52 | Week 24 | 3.7 Percentage of participants |
| Main Study: Group B: Placebo | Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52 | Week 52 | 3.7 Percentage of participants |
Comparison: Week 2480% CI: [42.1, 980.6]
Comparison: Week 5280% CI: [28.2, 601.9]
Secondary
Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52
The percentage of participants who experienced worsening of mRSS at Week 24 and Week 52 was reported. The worsening of mRSS was defined as an increase from baseline greater than or equal to (\>=) 5 points and \>=20 percent (%) in mRSS. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome.
Time frame: Week 24 and Week 52
Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52 | Week 24 | 3.4 Percentage of participants |
| Main Study: Group A: Guselkumab | Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52 | Week 52 | 20.7 Percentage of participants |
| Main Study: Group B: Placebo | Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52 | Week 52 | 77.8 Percentage of participants |
| Main Study: Group B: Placebo | Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52 | Week 24 | 25.9 Percentage of participants |
Comparison: Week 2480% CI: [0, 0.3]
Comparison: Week 5280% CI: [0, 0.2]
Secondary
Main Study: Serum Concentration of Guselkumab
Serum concentration of guselkumab was reported. The lower limit of quantification (LLOQ) for guselkumab was 0.01 micrograms per milliliter (mcg/mL).
Time frame: Pre-dose at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Post- dose at Weeks 0, 4, 8
Population: Pharmacokinetics analysis set included all participants who received at least 1 complete administration of guselkumab and had at least 1 observed post dose PK data. Here, 'n' (number analyzed) refers to participants evaluable at specified time points. This outcome measure was planned to be analyzed for specified arm only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 40 | 13.375 mcg/mL | Standard Deviation 6.1989 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 44 | 12.469 mcg/mL | Standard Deviation 6.8698 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 48 | 12.074 mcg/mL | Standard Deviation 6.1027 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 0 | NA mcg/mL | — |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Post-dose at Week 0 | 140.880 mcg/mL | Standard Deviation 26.5879 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 4 | 22.489 mcg/mL | Standard Deviation 6.9499 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Post-dose at Week 4 | 160.691 mcg/mL | Standard Deviation 31.7578 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 8 | 27.968 mcg/mL | Standard Deviation 9.7988 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Post-dose at Week 8 | 164.633 mcg/mL | Standard Deviation 28.9999 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 12 | 36.497 mcg/mL | Standard Deviation 13.7929 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 16 | 21.697 mcg/mL | Standard Deviation 9.6355 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 20 | 12.751 mcg/mL | Standard Deviation 6.0638 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 24 | 13.981 mcg/mL | Standard Deviation 6.6055 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 28 | 14.184 mcg/mL | Standard Deviation 5.698 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 32 | 12.564 mcg/mL | Standard Deviation 5.6367 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 36 | 12.932 mcg/mL | Standard Deviation 6.4345 |
| Main Study: Group A: Guselkumab | Main Study: Serum Concentration of Guselkumab | Pre-dose at Week 52 | 11.363 mcg/mL | Standard Deviation 6.6822 |