Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-38518168 · 6 trials · 5 indications
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.
Expressed as percent of predicted value.
Amount excreted into the urine during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the urinary volume with the urinary concentration for that interval.
Amount excreted into the feces during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the feces weight with the feces concentration for that interval
Amount excreted into the vomit during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the weight of the vomit with the vomit concentration for that interval
| 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. |
| JNJ-38518168 | EXPERIMENTAL | - |
| Group 1: JNJ-38518168 3 mg/ ketoconazole | EXPERIMENTAL | - |
| Group 2: JNJ-38518168 30 mg/ ketoconazole | EXPERIMENTAL | - |
| Group 3: JNJ-38518168 10 mg/ ketoconazole (optional) | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | PLACEBO_COMPARATOR | - |
| 5 | EXPERIMENTAL | - |
| 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. |
| JNJ-38518168 | DRUG | JNJ-38518168, 30 mg tablet, taken once daily |
| JNJ-38518168 10 mg | DRUG | One oral daily dose of JNJ-38518168 10 mg for 25 days. |
| Ketoconazole 200 mg | DRUG | Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25. |
| JNJ-38518168 (30 mg) | DRUG | Type=range, unit=mg, number=30, form=tablet, route=oral use, in single and multiple doses for 14 days |
| JNJ-38518168 (10 mg) | DRUG | Type=range, unit=mg, number=10, form=tablet, route=oral use, in single and multiple doses for 14 days |
| JNJ-38518168 (3 mg) | DRUG | Type=range, unit=mg, number=3, form=tablet, route=oral use, in single and multiple doses for 14 days |
| Midazolam and JNJ-38518168 | DRUG | Midazolam: Type=exact, unit=mg, number=2.5, form=oral solution; route=oral use, on Days 1 and 15; JNJ-38518168: Type=exact, unit=mg, number=30, form=tablet, route=oral use, once daily from Day 2 through Day 15 |
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 ...
JNJ-38518168 is an investigational small molecule being studied for the treatment of moderate to severe plaque-type psoriasis and uncontrolled, persistent asthma. It has also been evaluated in clinical trials involving patients with rheumatoid arthritis and hepatic impairment.
JNJ-38518168 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ.
JNJ-38518168 is in Phase 2 clinical development. It has completed Phase 2 trials in patients with moderate to severe plaque-type psoriasis and in adults with uncontrolled, persistent asthma. The drug remains investigational and is not approved for any use.
JNJ-38518168 has been studied in several completed trials. NCT02295865 evaluated its safety and efficacy in psoriasis. NCT01823016 studied it in adults with uncontrolled, persistent asthma. NCT01450982 examined its effect on methotrexate levels in rheumatoid arthritis, and NCT01863784 assessed its pharmacokinetics in patients with hepatic impairment.
Yes, JNJ-38518168 is also known as Toreforant. In clinical trial NCT02295865, the study of JNJ-38518168 in participants with moderate to severe plaque-type psoriasis, the drug is referred to as Toreforant (JNJ-38518168).
JNJ-38518168 has completed a Phase 2 trial in symptomatic adult participants with uncontrolled, persistent asthma. This trial, NCT01823016, enrolled 166 participants across the United States, Canada, France, Germany, Israel, and the United Kingdom. The trial is completed, and the drug remains investigational.