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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959SSC2001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Guselkumab | Experimental | Participants will receive intravenous (IV) injection of Guselkumab Dose 1 at Week 0, 4, and 8 followed by subcutaneous (SC) injection of Dose 2 Guselkumab every 4 weeks (Q4W) from Week 12 to Week 48 (end of maintenance phase). Participants will receive SC injection of Guselkumab Dose 2 and IV injection of placebo at long-term extension (LTE) Weeks 52, 56, and 60 followed by SC injection of Guselkumab Dose 2 Q4W from LTE Week 64 until Week 100. |
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| Group B: Placebo | Placebo Comparator | Participants will receive IV injection of matching placebo at Week 0, 4, and 8 followed by SC injection of matching placebo Q4W from Week 12 to Week 48 (end of maintenance phase). Participants will receive SC injection of Placebo and IV injection of Guselkumab Dose 1 at LTE Weeks 52, 56, and 60 followed by SC injection of Guselkumab Dose 2 Q4W from LTE Week 64 until Week 100. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab Dose 1 | Drug | Guselkumab Dose 1 will be administered intravenously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chukyo Hospital | Aichi | 457 8510 | Japan | |||
| The University of Tokyo 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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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | LTE Period: Group A: Guselkumab Then Guselkumab | Participants who received guselkumab and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 200 mg SC injection and placebo IV infusion at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112. |
| FG003 | LTE Period: Group B: Placebo Then Guselkumab | Participants who received placebo and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 400 mg IV infusion and placebo SC injection at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study: Week 0-Week 60 |
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| Long-term Extension(LTE):Week52-Week 112 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and Week 24 |
|
All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
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| 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: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocarditis | Cardiac disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research MD | Janssen Pharmaceutical K.K. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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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 | Nov 15, 2022 | May 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2023 | May 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Guselkumab Dose 2 |
| Drug |
Guselkumab Dose 2 will be administered subcutaneously. |
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| Placebo | Drug | Placebo will be administered intravenously or subcutaneously. |
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| Baseline and Week 52 |
| 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. | Week 24 and Week 52 |
| 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. | Week 24 and Week 52 |
| 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. | Baseline, Week 24 and Week 52 |
| 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. | Baseline, Week 24 and Week 52 |
| 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. | Baseline, Week 24 and Week 52 |
| 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. | Baseline, Week 24 and Week 52 |
| 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. | Baseline, Week 24 and Week 52 |
| 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. | Baseline, Week 24 and Week 52 |
| 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. | From Baseline (Week 0) up to Week 24 and Week 52 |
| 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. | From Week 52 up to Week 112 |
| 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. | From Baseline (Week 0) up to Week 24 and Week 52 |
| 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. | From Week 52 up to Week 112 |
| 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. | From Baseline (Week 0) up to Week 24 and Week 52 |
| 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. | From Week 52 up to Week 112 |
| 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). | 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 |
| Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab | Serum concentration of guselkumab was reported. The LLOQ for guselkumab was 0.01 mcg/mL. | Pre-dose (at Weeks 56, 60, 64, 76, 88, 96) and Week 104 |
| 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. | From Baseline (Week 0) up to Week 52 |
| 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. | From Week 52 up to Week 104 |
| Tokyo |
| 113-8655 |
| Japan |
| Wakayama Medical University Hospital | Wakayama | 641 8510 | Japan |
| University of Fukui Hospital | Yoshida | 910-1193 | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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. |
| OG001 | 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. |
|
|
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and Week 52 |
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Number | Percentage of participants | Week 24 and Week 52 |
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Number | Percentage of participants | Week 24 and Week 52 |
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, Week 24 and Week 52 |
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Least Squares Mean | Standard Error | Percent predicted FVC | Baseline, Week 24 and Week 52 |
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Least Squares Mean | Standard Error | Milliliter/minute/millimeter mercury | Baseline, Week 24 and Week 52 |
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Least Squares Mean | Standard Error | Percent predicted DLCO | Baseline, Week 24 and Week 52 |
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Least Squares Mean | Standard Error | Ulcers | Baseline, Week 24 and Week 52 |
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| 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. | The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 24 and Week 52 |
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| 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. | 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. | Posted | Count of Participants | Participants | From Baseline (Week 0) up to Week 24 and Week 52 |
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| 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. | 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. | Posted | Count of Participants | Participants | From Week 52 up to Week 112 |
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| 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. | 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. | Posted | Count of Participants | Participants | From Baseline (Week 0) up to Week 24 and Week 52 |
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| 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. | 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. | Posted | Count of Participants | Participants | From Week 52 up to Week 112 |
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| 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. | 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. | Posted | Count of Participants | Participants | From Baseline (Week 0) up to Week 24 and Week 52 |
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| 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. | 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. | Posted | Count of Participants | Participants | From Week 52 up to Week 112 |
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| 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). | 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. | Posted | Mean | Standard Deviation | mcg/mL | 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 |
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| 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. | 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. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (at Weeks 56, 60, 64, 76, 88, 96) and Week 104 |
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| 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. | 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. | Posted | Count of Participants | Participants | From Baseline (Week 0) up to Week 52 |
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| 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. | 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. | Posted | Count of Participants | Participants | From Week 52 up to Week 104 |
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| 0 |
| 29 |
| 1 |
| 29 |
| 22 |
| 29 |
| EG001 | 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. | 0 | 27 | 1 | 27 | 26 | 27 |
| EG002 | LTE Period: Group A: Guselkumab Then Guselkumab | Participants who received guselkumab and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 200 mg SC injection and placebo IV infusion at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112. | 1 | 25 | 1 | 25 | 22 | 25 |
| EG003 | LTE Period: Group B: Placebo Then Guselkumab | Participants who received placebo and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 400 mg IV infusion and placebo SC injection at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112. | 0 | 26 | 0 | 26 | 22 | 26 |
| Ileus Paralytic | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Pneumatosis Intestinalis | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Systemic Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Dermatophytosis of Nail | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Herpes Zoster | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Streptococcal Infection | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Tinea Pedis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
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| Thermal Burn | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
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| Lymphocyte Count Decreased | Investigations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Neutrophil Count Decreased | Investigations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Platelet Count Decreased | Investigations | MedDRA Version 27.0 | Non-systematic Assessment |
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| White Blood Cell Count Decreased | Investigations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Miliaria | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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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 to allow for filing of a patent application.
| Odds Ratio (OR) |
| 0.1 |
| 2-Sided |
| 80 |
| 0.0 |
| 0.2 |
| Superiority |
| Odds Ratio (OR) |
| 130.3 |
| 2-Sided |
| 80 |
| 28.2 |
| 601.9 |
| Superiority |
| LS Mean difference |
| -14.2 |
| 2-Sided |
| 80 |
| -57.2 |
| 28.8 |
| Superiority |
| LS Mean Difference |
| 0.1 |
| 2-Sided |
| 80 |
| -1.4 |
| 1.7 |
| Superiority |
| LS Mean Difference |
| 0.21 |
| 2-Sided |
| 80 |
| -0.29 |
| 0.71 |
| Superiority |
| LS Mean Difference |
| 0.14 |
| 2-Sided |
| 80 |
| -2.13 |
| 2.42 |
| Superiority |
| LS Mean Difference |
| -4.3 |
| 2-Sided |
| 80 |
| -5.1 |
| -3.5 |
| Superiority |
| LS Mean Difference |
| -0.2355 |
| 2-Sided |
| 80 |
| -0.3730 |
| -0.0980 |
| Superiority |
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| Pre-dose at Week 4 |
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| Pre-dose at Week 8 |
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| Pre-dose at Week 12 |
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| Pre-dose at Week 16 |
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| Pre-dose at Week 20 |
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| Pre-dose at Week 24 |
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| Pre-dose at Week 28 |
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| Pre-dose at Week 32 |
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| Pre-dose at Week 36 |
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| Pre-dose at Week 40 |
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| Pre-dose at Week 44 |
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| Pre-dose at Week 48 |
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| Pre-dose at Week 52 |
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| Pre-dose at Week 60 |
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| Pre-dose at Week 64 |
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| Pre-dose at Week 76 |
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| Pre-dose at Week 88 |
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| Pre-dose at Week 96 |
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| Week 104 |
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