| Primary | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. | Full analysis set (FAS) included all participants who were randomized in the study. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg | Participants received guselkumab 100 mg by SC injection at Weeks 0, 4 and then every 8 weeks (q8w) through Week 44. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | | <0.001 | | Adjusted treatment difference | 61.8 | | | 2-Sided | 95 | 53.4 | 70.1 | | | | | Superiority | | |
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| Secondary | Percent Change From Baseline in Body Surface Area (BSA) at Week 16 | Percent change from baseline in BSA at Week 16 was reported. A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1 percent (%) BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg | Participants received guselkumab 100 mg by SC injection at Weeks 0, 4 and then every 8 weeks (q8w) through Week 44. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. |
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| Secondary | Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Total Score at Week 16 | Percent change from baseline in PASI total score at Week 16 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | |
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| Secondary | Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. | FAS included all participants who were randomized in the study. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 |
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| Secondary | Percentage of Participants Who Achieved PASI 90 Response at Week 16 | Percentage of participants who achieved PASI 90 score (greater than or equal to [>=] 90% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg |
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| Secondary | Percentage of Participants Who Achieved PASI 100 Response at Week 16 | Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg |
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| Secondary | Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Randomized Participants With Ss-IGA Score >=3 at Baseline | The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study and had a ss-IGA score >=3 at baseline. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg | Participants received guselkumab 100 mg by SC injection at Weeks 0, 4 and then every 8 weeks (q8w) through Week 44. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. |
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| Secondary | Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16 Among Randomized Participants With sPGA-G Score >=3 at Baseline | The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study and had a sPGA-G score >=3 at baseline. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg | Participants received guselkumab 100 mg by SC injection at Weeks 0, 4 and then every 8 weeks (q8w) through Week 44. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. |
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| Secondary | Percentage of Participants Who Achieved Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With an i-IGA Score >=3 at Baseline | The IGA used for the full body assessment was adapted with descriptions of disease features that were more consistent with intertriginous psoriasis presentation. The intertriginous areas assessed included the axillary, sub mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The i-IGA was 5-point scale evaluating the severity of plaque psoriasis in the intertriginous area with scores defined as clear (0), minimal (1), mild (2), moderate (3), and severe (4). A higher score indicated greater disease severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study and had a i-IGA score >=3 at baseline. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg | |
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| Secondary | Percentage of Participants Who Achieved Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With f-IGA Score >=3 at Baseline | The standard IGA used for full body evaluation was adapted for assessment of psoriasis on the face only. The f-IGA used a 5-point scale to assess overall facial disease severity, defined as clear (0), minimal (1), mild (2), moderate (3), and severe (4). A higher score indicated more severe facial psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study and had a f-IGA score >=3 at baseline. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg | Participants received guselkumab 100 mg by SC injection at Weeks 0, 4 and then every 8 weeks (q8w) through Week 44. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. |
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| Secondary | Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16 | The PSSD was a patient reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 7-day recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales were answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a scale | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. |
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| Secondary | Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline was defined as the closest measurement taken prior to or at time of first study drug administration date. | FAS included all participants who were randomized in the study and had a PSSD itch score >=4 at baseline. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 | Group 2: Guselkumab 100 mg | |
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| Secondary | Percentage of Participants Who Achieved PSSD Individual Symptom Scale Score=0 at Week 16 Among Participants With a PSSD Symptom Score >0 at Baseline | The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 7-day recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | FAS included all participants who were randomized in the study and had a PSSD symptom score >0 at baseline. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. | | OG001 |
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| Secondary | 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 pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any event that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration. | Safety analysis set included all participants who received at least 1 (complete or partial) administration of study intervention. Per plan, data for adverse events was collected and analyzed per intervention. | Posted | | Count of Participants | | Participants | | Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12. | | OG001 | Group 1: Placebo Followed by Guselkumab 100 mg | Participants who were randomized to receive placebo crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, 28, 36, and 44. Participants were then followed up for efficacy up to Week 48 and for safety up to Week 56. |
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| Secondary | Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious adverse event (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. TEAE was defined as any event that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration. | Safety analysis set included all participants who received at least 1 (complete or partial) administration of study intervention. Per plan, data for adverse events was collected and analyzed per intervention. | Posted | | Count of Participants | | Participants | | Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56 | | | | ID | Title | Description |
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| OG000 | Group 1: Placebo | Participants received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12. | | OG001 | Group 1: Placebo Followed by Guselkumab 100 mg | |
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