Phase 2a study of JNJ-38618168 in asthmatics
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of JNJ-38518168ASH2001 in Syptomatic Adult Subjects with Uncontrolled, Persistent Asthma.
IRAS ID
129736
Contact name
Manish Saxena
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2012-004920-39
ISRCTN Number
Not provided
Clinicaltrials.gov Identifier
Not provided
Research summary
This study is being conducted on behalf of Janssen Research & Development.
This is a randomised (individuals will be assigned by chance to one of the two study treatments), double-blind (neither the individual or the hospital team will not know the identity of study treatments), parallel group (1 group of individuals receives treatment A and the other group of individuals receives treatment B) study of JNJ-38518168 compared with placebo (dummy drug) in adult subjects with uncontrolled, persistent asthma.
Approximately 160 subjects from 55 sites will take part in the study.
JNJ-38518168 is a new oral drug that is easily absorbed by the body that binds to a group of histamine receptors (called H4 receptors) to prevent the effects caused by histamine. Histamine is a chemical mediator that is released during allergic reactions. JNJ-38518168 is currently under investigation for the treatment of asthma and rheumatoid arthritis.
The study will be approximately 32 weeks in duration, which is comprised of a screening phase of approximately 4 weeks, a 24-week treatment phase and a 4-week follow-up phase. The end of the study is defined as the last follow-up visit of the last subject.
REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/0807
Date of REC Opinion
16 Aug 2013
REC opinion
Further Information Favourable Opinion