A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma

Phase 2 Completed 166 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.

Timeline

Start: 2013-09
Primary completion: 2015-07
Completion: 2015-07

Outcome

Missed primary endpoint

paper There was no significant difference between groups in pre-bronchodilator percent-predicted forced expiratory volume in 1 second at week 16 PMID 30102965 ↗

paper difference in least-square means -0.19%; 95% confidence interval -3.01 to 2.64; P = .90 PMID 30102965 ↗

Publications

Kollmeier AP, Barnathan ES, O'Brien C, Chen B, Xia YK, Zhou B, Loza MJ, Silkoff PE, Ge M, Thurmond RL. A phase 2a study of toreforant, a histamine H4 receptor antagonist, in eosinophilic asthma. Ann Allergy Asthma Immunol. 2018 Nov;121(5):568-574. doi: 10.1016/j.anai.2018.08.001. Epub 2018 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TOREFORANT	Small molecule	30 mg	—