| Primary | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16 | IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using 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; 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at the time of first study drug administration date. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
| | | Title | Denominators | Categories |
|---|
| | |
| | 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 |
|---|
| | Cochran-Mantel-Haenszel | | <0.001 | | Treatment difference | 62.6 | | | 2-Sided | 95 | 53.3 | 69.5 | | | | | Superiority | | |
|
| Primary | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Percentage of participants who achieved PASI-90 score (>=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 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 at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percentage of Participants Who Achieved IGA Score of 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, >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). A higher score indicated more severe disease. | FAS included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percentage of Participants Who Achieved PASI 75 Response at Weeks 4 and 16 | Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 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 at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 4 and 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percentage of Participants Who Achieved PASI 90 Response at Week 8 | Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 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 at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| 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 at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2 | 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. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had baseline ss-IGA score >=2. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 | Arm 2: JNJ-77242113 200 mg |
|
| Secondary | Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was 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. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline PSSD symptom score >0. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 8 and 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Among Participants With a Baseline PSSD Itch Score >=4 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour 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=closest measurement taken prior to or at time of first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the stud and were evaluable for efficacy analysis, and had a baseline in PSSD itch score >=4. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 4 and 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24 | IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm; 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation,>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 lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease.Baseline=closest measurement taken prior to or at time of first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24 | 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, >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). A higher score indicated more severe disease. | FAS included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 |
|
| Secondary | Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24 | Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 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 at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 |
|
| Secondary | Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24 | Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 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 at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 |
|
| Secondary | Percentage of Participants Who Achieved PASI 100 Response at Weeks 16 and 24 | Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 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 at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 |
|
| Secondary | Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was 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. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline PSSD symptom score >0. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | |
|
| Secondary | Change From Baseline in Body Surface Area (BSA) at Week 16 | 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% 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 at Week 0 in the study and were evaluable for efficacy analysis. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | | Mean | Standard Deviation | Percentage of BSA | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 | Arm 2: JNJ-77242113 200 mg | |
|
| Secondary | Change From Baseline in PASI Total Score at Week 16 | Change from baseline in PASI total score 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 at Week 0 in the study and were evaluable for efficacy analysis. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percent Change From Baseline in PASI Total Score at Week 16 | Percent change from baseline in PASI total score 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 at Week 0 in the study and were evaluable for efficacy analysis. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
|
| Secondary | Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2 | 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. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline sPGA-G score >=2. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 | Arm 2: JNJ-77242113 200 mg |
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| Secondary | Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Hf-PGA Score >=2 | The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet. hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher score indicates more severity. Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline hf-PGA score >=2. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 |
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| Secondary | Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0 | Percent change from baseline in mNAPSI score at week 16 was reported. The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails were evaluated on 7 features. The first three features were each scored from 0 to 3 in severity and were 1=onycholysis and oil-drop dyschromia, 2=pitting, and 3=nail plate crumbling. Next four features was each scored 0 (absent) or 1 (present), and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula. Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). Higher the score the more severe the nail bed psoriasis. Baseline=closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population=all participants who randomized at Week 0 in study and were evaluable for efficacy analysis, and had baseline mNAPSI score >0. 'N' (Overall number of participants analyzed)=number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
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| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg |
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| Secondary | Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2 | Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. Baseline = closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline f-PGA score >=2. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | | OG001 |
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| Secondary | Change From Baseline in PSSD Symptom Score at Week 16 | Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was 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. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). 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 at Week 0 in the study and were evaluable for efficacy analysis. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
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| Secondary | Change From Baseline in PSSD Sign Score at Week 16 | Change from baseline in PSSD sign scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was 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. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). 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 at Week 0 in the study and were evaluable for efficacy analysis. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
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| Secondary | Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was 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. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline sign score >0. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
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| Secondary | Percentage of Participants Who Achieved Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With a Baseline GenPS-SFQ Item 2 Score >=2 and With a Baseline sPGA-G Score >=3 | The GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always). Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline GenPS-SFQ item 2 score >=2 and a baseline sPGA-G score >=3. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
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| Secondary | Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1 | The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
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| Secondary | Change From Baseline in Total DLQI Score at Week 16 | The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. 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 at Week 0 in the study and were evaluable for efficacy analysis. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. This outcome measure was planned to be analyzed for specified arm only. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg | Participants were randomized to receive placebo matching to JNJ-77242113 tablet orally once daily (QD) from Week 0 to Week 16, and then crossed-over to receive JNJ-77242113 200 milligrams (mg) tablet orally QD from Week 16 to Week 24. Participants also received placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
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| Secondary | Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16 | PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured that is higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to or at time of first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis. Here, 'N' (Overall number of participants analyzed) signifies number of participants with non-missing data for this outcome measure after applying predefined intercurrent event rules. Participants with missing assessments were not included, as no further imputation was applied for missing data. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline (Week 0), Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: Placebo Followed by JNJ-77242113 200 mg |
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| Secondary | Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1 | The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline DLQI score >1. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Weeks 16 and 24 | | | | ID | Title | Description |
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| OG000 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. | |
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| Secondary | Percentage of Participants Who Achieved PSSD Symptoms Score of 0 at Week 24 Among Participants With a Baseline PSSD Symptom Score >0 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was 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. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. | Analysis population only included all participants who were randomized at Week 0 in the study and were evaluable for efficacy analysis, and had a baseline PSSD symptom score >0. Non-responder imputation was applied for missing data after applying predefined intercurrent event rules. This outcome measure was planned to be analyzed for specified arms only. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm 2: JNJ-77242113 200 mg | Participants were randomized to receive JNJ-77242113 200 mg tablet and a placebo matching to deucravacitinib capsule orally QD from Week 0 to Week 24. |
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| Secondary | Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24 | | | Not Posted | Sep 2028 | | | | | From Week 24 up to Week 160 | | Participants | | | | |
| Secondary | Percentage of Participants Achieving PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24 | | | Not Posted | Sep 2028 | | | | | From Week 24 up to Week 160 | | Participants | | | | |
| Secondary | Percentage of Participants Achieving IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24 | | | Not Posted | Sep 2028 | | | | | From Week 24 up to Week 160 | | Participants | | | | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | | | Not Posted | Sep 2028 | | | | | From Week 0 to Week 160 | | Participants | | | | |
| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | | | Not Posted | Sep 2028 | | | | | From Week 0 to Week 160 | | Participants | | | | |