Trial Outcomes & Findings for A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis (NCT NCT05364554)

Total of 227 participants entered study 77242113PSO2002 (long-term extension \[LTE\]) after completing originating study 77242113PSO2001 (NCT05223868) Week 16. Per plan, data collected from Week 0 of originating study was analyzed for efficacy while data from Week 0 of current study (referred as LTE Week 0) was analyzed for safety.

A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis

Percentage of participants who achieved \>=75% improvement from baseline in PASI score at LTE Week 36 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.

Percentage of participants who achieved \>=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.

Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: 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 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.

Change from baseline in PASI total score at LTE Week 36 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 first study drug administration date in 77242113PSO2001 study.

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). A higher score indicated more severe disease.

Change from baseline in PSSD symptoms scores at LTE Week 36 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD: 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 scales for severity. Items were averaged on the daily 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. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.

Change from baseline in PSSD sign scores at LTE Week 36 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 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 daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales were answered. The average value was converted into 0-100 scoring, such that sign 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 first study drug administration date in 77242113PSO2001 study.

The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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 daily symptom score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is 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 first study drug administration date in 77242113PSO2001 study.

The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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 daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales are answered. The average value is converted into 0-100 scoring, such that sign 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 first study drug administration date in 77242113PSO2001 study.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A 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 AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported.