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JNJ39758979

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

JNJ39758979 · 1 trial · 1 indication

Phase 2 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.

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.

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.
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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 StatesCanadaIndiaRomania
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Frequently asked questions about JNJ39758979

What is JNJ-39758979 used for?

JNJ-39758979 is an investigational small molecule being studied for the treatment of asthma and rheumatoid arthritis. It is being developed by Johnson & Johnson (JNJ) and has been evaluated in clinical trials for these conditions.

Who makes JNJ-39758979?

JNJ-39758979 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company has sponsored clinical trials of the drug in asthma and rheumatoid arthritis.

What phase is JNJ-39758979 in?

JNJ-39758979 is an investigational drug that has completed clinical trials. One trial was a Phase 2 study in asthma, and another was a Phase 1 study in rheumatoid arthritis. It is not approved and remains in clinical development.

What clinical trials is JNJ-39758979 in?

JNJ-39758979 has been studied in two completed trials. NCT00946569 was a Phase 2 study in adults with persistent asthma, enrolling 116 participants in the United States, Canada, India, and Romania. NCT01442545 was a Phase 1 study in rheumatoid arthritis participants, enrolling 21 participants in the United States and Germany.

Is JNJ-39758979 the same as MTX?

JNJ-39758979 is not the same as MTX, which is methotrexate. In a clinical trial, JNJ-39758979 was studied to investigate how it may affect the plasma levels of methotrexate in rheumatoid arthritis participants, indicating the two are distinct drugs.