Plaque Psoriasis
Conditions
Interventions
JNJ-77242113:JNJ-77242113 tablet will be administered orally.
Group 1: JNJ-77242113Dose 1 Once Daily (QD)
Group 2: JNJ-77242113Dose 2 QD
Group 3: JNJ-77242113Dose 3 QD
Group 4: JNJ-77242113Dose 1 Twic
Sponsors
Nakano Masayoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Must have completed the Week 16 visit in Protocol 77242113PSO2001 - In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study - Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study - Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention - Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention
Exclusion criteria
Exclusion criteria: - Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason - Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001 - Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention - Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention - Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36:Week 36:Percentage of participants achieving PASI 75 score (greater than or equal to [>=] 75 percent [%] improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI 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 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Percentage of Participants Achieving PASI 90 Score at Week 36:Week 36:Percentage of participants achieving PASI 90 score (>=90% improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI 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 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. -Percentage of Participants Achieving PASI 100 Score at Week 36:Week 36:Percentage of participants achieving PASI 100 score (>=100% improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI 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 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. -Change From Baseline in PASI Total Score at Week 36:Baseline and Week 36:Change from baseline of the originating study (77242113PSO2001) in PASI total score at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI 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 fo | — |
Countries
Canada, France, Germany, Japan, Korea, Poland, Spain, Taiwan, UnitedKingdom Of Great Britain, UnitedStates Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed