Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02295865 | A Study to Evaluate Safety and Efficacy of Toreforant (JNJ-38518168) in Participants With Moderate to Severe Plaque-type Psoriasis | PHASE2 | COMPLETED | 62 | — | — | Nov 17, 2014 | Mar 11, 2016 | Jul 7, 2017 | 13 | United States, Poland |
The PASI score is a combined assessment of lesion severity and area affected into single score. Body will be divided into 4 sections:head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated:0=0%, 1=less than (\<) 10%, 2=10 to \<30%, 3=30 to \<50%, 4=50 to \<70%, 5=70 to \<90%, 6=90 to 100%. Severity will be estimated by clinical signs:erythema,induration,desquamation;scale:0= none to 4=maximum. Final PASI=sum of severity parameters for each section\*area score\*weight of section (head:0.1,arms:0.2,body:0.3,legs:0.4);total possible score range: 0=no disease to 72=maximal disease. A PASI 75 response defined as greater than or equal to (\>=) 75 % improvement in PASI score from baseline.
| Arm | Type | Description |
|---|---|---|
| JNJ-38518168 60 mg | EXPERIMENTAL | Participants will receive two tablets of JNJ-38518168, 30 milligram (mg) each for a total of 60 mg, together with one 30 mg matching placebo tablet and one 3 mg matching placebo tablet, orally, once daily, for 12 Weeks. |
| JNJ-38518168 30 mg | EXPERIMENTAL | Participants will receive one tablet of JNJ-38518168, 30 mg, together with two 30 mg matching placebo tablets and one 3 mg matching placebo tablet, orally, once daily, for 12 Weeks. |
| JNJ-38518168 3 mg | EXPERIMENTAL | Participants will receive one tablet of JNJ-38518168, 3 mg, together with three 30 mg matching placebo tablets, orally, once daily, for 12 Weeks. |
| Placebo | EXPERIMENTAL | Participants will receive three tablets of JNJ-38518168, 30 mg matching placebo, together with one 3 mg matching placebo tablet, orally, once daily, for 12 Weeks. |
| Name | Type | Description |
|---|---|---|
| JNJ-38518168 60 mg | DRUG | Two tablets of JNJ-38518168, 30 milligram (mg) each for a total of 60 mg, orally, once daily. |
| JNJ-38518168 30 mg | DRUG | One tablet of JNJ-38518168, 30 mg, orally, once daily. |
| JNJ-38518168 3 mg | DRUG | One tablet of JNJ-38518168, 3 mg, orally, once daily. |
| Placebo | DRUG | Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally. |
Inclusion Criteria: * Participant must have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis \[PsA\]) for at least 6 months before the first administration of study drug * Participant must have a Psoriasis Area and Severity Index (PASI) Greater Than or equal to (\>=) 12 at ...