NCT01673672

CYT003-QbG10, a TLR9-agonist, for Treatment of Uncontrolled Moderate to Severe Allergic Asthma

A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients With Moderate to Severe Allergic Asthma Not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Cytos Biotechnology AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the therapeutic potential and safety/tolerability of study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard controller therapy. Altogether 360 patients randomized to 4 treatment groups will be included. The study compares three dose strength with placebo. Each patient receives 7 injections of study drug or undistinguishable placebo. Key outcome measures are patient reported parameters on their asthma.

Conditions

• Moderate to Severe Allergic Asthma

Interventions

Type	Name	Description
BIOLOGICAL	CYT003	7 subcutaneous injections, weekly/biweekly within 10 weeks
BIOLOGICAL	Placebo	7 subcutaneous injections, weekly/biweekly within 10 weeks

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-08-28
• Last updated: 2014-05-14

Locations

34 sites across 8 countries: United States, Czechia, Germany, Hungary, Israel, Poland, Russia, Ukraine