| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06934226 | A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis | PHASE3 | ACTIVE NOT_RECRUITING | 752 | — | — | Apr 15, 2025 | Aug 20, 2027 | Jun 5, 2026 | 160 | United States, Argentina +11 |
| NCT06220604 | A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2) | PHASE3 | ACTIVE NOT_RECRUITING | 731 | — | — | Mar 9, 2024 | Sep 20, 2027 | Mar 12, 2026 | 128 | United States, Australia +9 |
| NCT06143878 | A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis | PHASE3 | ACTIVE NOT_RECRUITING | 774 | — | — | Feb 1, 2024 | Jun 1, 2027 | Mar 12, 2026 | 164 | United States, Argentina +11 |
| NCT06095102 | A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet) | PHASE3 | ACTIVE NOT_RECRUITING | 311 | — | — | Oct 12, 2023 | Feb 17, 2027 | Mar 13, 2026 | 90 | United States, Argentina +9 |
| NCT06095115 | A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis | PHASE3 | ACTIVE NOT_RECRUITING | 684 | — | — | Oct 12, 2023 | Apr 6, 2027 | Jun 8, 2026 | 170 | United States, Argentina +14 |
| NCT05357755 | A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis | PHASE2 | COMPLETED | 90 | — | — | Jun 13, 2022 | Apr 10, 2023 | May 5, 2026 | 34 | United States, Canada +4 |
| NCT05364554 | A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis | PHASE2 | COMPLETED | 227 | — | — | Jun 10, 2022 | Sep 29, 2023 | Jun 1, 2026 | 60 | United States, Canada +8 |
| NCT05223868 | A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis | PHASE2 | COMPLETED | 255 | — | — | Feb 3, 2022 | Dec 15, 2022 | Feb 13, 2026 | 76 | United States, Canada +8 |
IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score.
Percentage of participants achieving an IGA score of 0 or 1 and \>=2 grade improvement from baseline at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Percentage of participants who achieve an IGA score of 0 or 1 and \>=2-Grade improvement from baseline to Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Percentage of participants who achieve an IGA score of 0 or 1 and \>=2 grade improvement from baseline at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
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,=0.5mm;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 \<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 a 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.
Percentage of participants who achieved PASI 90 (at least 90% improvement from baseline in PASI score) response at Week 16 were 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.
Percentage of participants who achieved PASI-75 score (greater than or equal to \[\>=\] 75% improvement from baseline in PASI) at Week 16 were 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.
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 PASI-75 score (greater than or equal to \[\>=\] 75% 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.
| Arm | Type | Description |
|---|---|---|
| Arm 1: JNJ 77242113 | EXPERIMENTAL | Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind. |
| Arm 2: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104. |
| Arm 3: Ustekinumab | ACTIVE_COMPARATOR | Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28. |
| JNJ-77242113 | EXPERIMENTAL | Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156. |
| Deucravacitinib | ACTIVE_COMPARATOR | Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156. |
| Group 1: JNJ-77242113 Dose 1 | EXPERIMENTAL | Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16. |
| Group 2: JNJ-77242113 Dose 2 | EXPERIMENTAL | Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16. |
| Group 3: Placebo | PLACEBO_COMPARATOR | Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16. |
| Group 1: JNJ-77242113 Dose 1 Once Daily (QD) | EXPERIMENTAL | Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study. |
| Group 2: JNJ-77242113 Dose 2 QD | EXPERIMENTAL | Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study. |
| Group 3: JNJ-77242113 Dose 3 QD | EXPERIMENTAL | Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study. |
| Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) | EXPERIMENTAL | Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study. |
| Group 5: JNJ-77242113 Dose 3 BID | EXPERIMENTAL | Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study. |
| Group 6: JNJ-77242113 Dose 3 QD | EXPERIMENTAL | Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study. |
| Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo | EXPERIMENTAL | Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
| Group 2: JNJ-77242113 Dose 2 QD and Placebo | EXPERIMENTAL | Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
| Group 3: JNJ-77242113 Dose 3 QD and Placebo | EXPERIMENTAL | Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
| Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo | EXPERIMENTAL | Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
| Group 5: JNJ-77242113 Dose 3 BID and Placebo | EXPERIMENTAL | Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens. |
| Group 6: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo BID from Week 0 through Week 16. |
| Name | Type | Description |
|---|---|---|
| JNJ-77242113 | DRUG | JNJ-77242113 will be administered orally. |
| Matching Placebo to JNJ-77242113 | DRUG | Matching placebo will be administered orally. |
| Ustekinumab | DRUG | Ustekinumab will be administered subcutaneously. |
| Matching Placebo to Ustekinumab | DRUG | Matching placebo will be administered subcutaneously. |
| JNJ-77242113 Matching Placebo | DRUG | JNJ-77242113 matching placebo will be administered orally. |
| Deucravacitinib | DRUG | Deucravacitinib will be administered orally. |
| Deucravacitinib Matching Placebo | DRUG | Deucravacitinib matching placebo will be administered orally. |
| Placebo | DRUG | Placebo will be administered orally. |
Inclusion Criteria: * Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention * Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline * Total psoriasis area and severity index (P...