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

NCT01673672 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2014-05-14

No results posted yet for this study

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

BIOLOGICAL

CYT003

7 subcutaneous injections, weekly/biweekly within 10 weeks

BIOLOGICAL

Placebo

7 subcutaneous injections, weekly/biweekly within 10 weeks

Sponsors & Collaborators

  • Cytos Biotechnology AG

    lead INDUSTRY

Principal Investigators

  • Thomas B Casale, Professor · Creighton University, Omaha (NE)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01673672 on ClinicalTrials.gov