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JNJ-39758979/ MTX

Phase 2

Asthma | Small molecule | Respiratory |Johnson & Johnson|Trials Updated: Apr 29, 2014

JNJ-39758979/ MTX target and mechanism

ModalitySmall molecule

Also known as JNJ39758979

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment137

FDA Designations

No designations recorded

JNJ-39758979/ MTX clinical trials

JNJ-39758979/ MTX · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00946569A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent AsthmaAsthma
COMPLETED116 Analytics
PHASE2COMPLETED
A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change from baseline to Week 12 in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
Baseline (Week 0) and Week 12

FEV1 will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol.

Blood levels of methotrexate
Up to approximately 7 weeks

To assess the effect of multiple doses of JNJ-39758979 on blood levels of methotrexate

Secondary Endpoints

Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
Week 1, Week 2, Week 4, and Week 8
Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
Week 4 and Week 12
Percent change from baseline in pre-bronchodilator percent predicted Forced Vital Capacity (FVC) value
Week 1, Week 2, Week 4, Week 8, and Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment A (JNJ39758979)EXPERIMENTALParticipants will receive JNJ39758979 300mg once daily for 12 weeks.
Treatment B (Placebo)PLACEBO_COMPARATORParticipants will receive matching placebo once daily for 12 weeks.
001EXPERIMENTAL -

Interventions

NameTypeDescription
JNJ39758979DRUGParticipants will receive capsule-shaped tablet of JNJ39758979 300mg once daily orally for 12 weeks.
PlaceboDRUGParticipants will receive matching placebo once daily orally for 12 weeks.
JNJ-39758979 / MTXDRUGDay 1: MTX: Route=oral use, single dose of participant's weekly MTX dose; Days 3-15: MTX: Route=oral use, single dose of participant's weekly MTX dose and JNJ 39758979: Type=exact, unit=mg, number=300, form=tablet, route=oral use, administered daily.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Confirmed diagnosis of asthma for at least 6 months * Short-acting beta-agonist use greater than or equal to 5 times in the 2 weeks prior to screening * Healthy on the basis of physical examination, medical history, vital signs, and 12 lead ECG performed at screening * Having ...

Countries:United StatesCanadaIndiaRomaniaGermany
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Frequently asked questions about JNJ-39758979/ MTX

What is JNJ-39758979/ MTX?

JNJ-39758979/ MTX refers to the small molecule JNJ-39758979 evaluated in combination with methotrexate (MTX) in rheumatoid arthritis. Johnson & Johnson developed the drug. It has been studied in a Phase 1 drug interaction trial with methotrexate and a Phase 2 trial in persistent asthma. The combination is investigational.

What is JNJ-39758979/ MTX used for?

JNJ-39758979/ MTX has been studied for rheumatoid arthritis and asthma. The Phase 1 trial NCT01442545 examined how JNJ-39758979 affects methotrexate plasma levels in rheumatoid arthritis participants. The Phase 2 trial NCT00946569 evaluated JNJ-39758979 in adults with persistent asthma. Both indications remain investigational.

Who makes JNJ-39758979/ MTX?

Johnson & Johnson, ticker JNJ, is the developer of JNJ-39758979 and the sponsor of its clinical trials, including the combination with methotrexate. The company conducted the Phase 1 methotrexate interaction study and the Phase 2 asthma study.

What phase is JNJ-39758979/ MTX in?

JNJ-39758979/ MTX has completed a Phase 1 trial and a Phase 2 trial. The Phase 1 study NCT01442545 investigated the effect of JNJ-39758979 on methotrexate plasma levels in rheumatoid arthritis. The Phase 2 study NCT00946569 tested JNJ-39758979 in persistent asthma. No active trials are ongoing.

What clinical trials is JNJ-39758979/ MTX in?

JNJ-39758979/ MTX has been studied in two completed trials. NCT01442545 was a Phase 1 trial in rheumatoid arthritis that examined how JNJ-39758979 affects methotrexate plasma levels, enrolling 21 participants in the United States and Germany. NCT00946569 was a Phase 2 trial in persistent asthma, enrolling 116 participants across the United States, Canada, India, and Romania.