Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-38518168
JNJ-38518168/ MTX · 4 trials · 4 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.
To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate
| 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 | - |
| 001 | EXPERIMENTAL | JNJ-38518168 / MTX Day 1: MTX: Route=oral use single dose of participant's weekly MTX dose Days 2-15: MTX: Route=oral use single dose of participant's weekly MTX dose and of JNJ-38518168 Type=exact unit=mg number=100 form=capsule route=oral use administered daily. |
| 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 / MTX | DRUG | Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose |
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 ...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
JNJ-38518168 is an investigational small molecule studied in asthma, psoriasis, rheumatoid arthritis, and hepatic impairment. It has been evaluated in Phase 2 trials for moderate to severe plaque-type psoriasis and for uncontrolled, persistent asthma, and in Phase 1 studies in rheumatoid arthritis and hepatic impairment. It is not an approved treatment.
JNJ-38518168 is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical studies of the compound across asthma, psoriasis, rheumatoid arthritis, and hepatic impairment.
JNJ-38518168 has reached Phase 2 in its clinical development. Phase 2 studies were conducted in moderate to severe plaque-type psoriasis and in uncontrolled, persistent asthma, while Phase 1 studies covered rheumatoid arthritis and hepatic impairment. All of these trials are completed.
JNJ-38518168 has been studied in completed trials including NCT02295865 in moderate to severe plaque-type psoriasis, NCT01823016 in uncontrolled persistent asthma, NCT01863784 in mild and moderate hepatic impairment, and NCT01450982 in rheumatoid arthritis. The asthma trial enrolled 166 participants, the largest of these studies.
Yes, JNJ-38518168 is also known as toreforant. Other names used for the compound include JNJ-38518168 3 mg, JNJ-38518168 30 mg, and JNJ-38518168 60 mg, which refer to dose strengths studied in trials. Searches for any of these names refer to the same investigational small molecule.
The JNJ-38518168 trials were randomized, double-blind, and placebo-controlled. The Phase 2 psoriasis study NCT02295865 enrolled 62 participants in the United States and Poland, and the Phase 2 asthma study NCT01823016 enrolled 166 participants across the United States, Canada, France, Germany, Israel, and the United Kingdom.