Who is sponsoring NCT01673672?

NCT01673672 is sponsored by Cytos Biotechnology AG.

What condition does NCT01673672 study?

NCT01673672 studies Moderate to Severe Allergic Asthma.

What drugs are being tested in NCT01673672?

Interventions: CYT003, Placebo.

What is the status of NCT01673672?

NCT01673672 is currently TERMINATED.

Last reviewed 2014-05-13 · How we verify

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)

NCT01673672 Phase 2 TERMINATED

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.

Details

Lead sponsor	Cytos Biotechnology AG
Phase	Phase 2
Status	TERMINATED
Enrolment	365
Start date	2012-11
Completion	2014-05

Conditions

Moderate to Severe Allergic Asthma

Interventions

CYT003
Placebo

Primary outcomes

Asthma Control Questionnaire — 1 year

Countries

United States, Czechia, Germany, Hungary, Israel, Poland, Russia, Ukraine