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CYT 003, a TLR 9 agonist, in persistent allergic asthma – a randomized placebo‐controlled Phase 2b study
Author(s) -
Casale T. B.,
Cole J.,
Beck E.,
Vogelmeier C. F.,
Willers J.,
Lassen C.,
HammannHaenni A.,
Trokan L.,
Saudan P.,
Wechsler M. E.
Publication year - 2015
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/all.12663
Subject(s) - medicine , placebo , asthma , adverse effect , minimal clinically important difference , confidence interval , quality of life (healthcare) , randomized controlled trial , anesthesia , agonist , receptor , alternative medicine , nursing , pathology
Background New treatment options are required for patients with asthma not sufficiently controlled with inhaled therapies. In a P hase 2a trial, CYT 003, a T oll‐like receptor‐9 agonist immunomodulator, improved asthma control during inhaled glucocorticosteroid reduction in patients with allergic asthma. This double‐blind P hase 2b study assessed the efficacy and safety of CYT 003 in patients with persistent moderate‐to‐severe allergic asthma not sufficiently controlled on standard inhaled glucocorticosteroid therapy with/without long‐acting beta‐agonists ( LABA s). Methods Overall, 365 patients received seven doses of subcutaneous CYT 003 (0.3, 1, or 2 mg) or placebo as add‐on therapy to conventional controller medication. Change from baseline in A sthma C ontrol Q uestionnaire ( ACQ ) score was the primary outcome; secondary outcomes included change in forced expiratory volume, M ini A sthma Q uality of L ife Q uestionnaire, and safety. Results All groups, including placebo, showed a clinically important improvement in ACQ score; however, there was no significant difference between the CYT 003 and placebo groups at week 12 (least‐squares mean difference 0.3 mg: −0.027 [95% confidence interval −0.259 to 0.204]; 1 mg: 0.097 [−0.131 to 0.325]; 2 mg: 0.081 [−0.148 to 0.315]). No significant differences were seen in secondary outcomes. CYT 003 was well tolerated; the most common treatment‐emergent adverse events were injection site reactions. Due to lack of efficacy, the study was prematurely terminated at the end of the treatment phase with no further follow‐up. Conclusions Toll‐like receptor‐9 agonism with CYT 003 showed no additional benefit in patients with insufficiently controlled moderate‐to‐severe allergic asthma receiving standard inhaled glucocorticosteroid therapy with or without LABA s.