Moderate to Severe Allergic AsthmaPhase 2NCT01673672
CYT003-QbG10, a TLR9-agonist, for Treatment of Uncontrolled Moderate to Severe Allergic Asthma
A Phase 2 study testing CYT003 in people with Moderate to Severe Allergic Asthma, run by Cytos Biotechnology AG at 34 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate to Severe Allergic Asthma
- What is being tested?
- CYT003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 34 sitesin 8 countries
- Study dates
- Nov 2012to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent
- Able and willing to complete all protocol requirements
- Between 18 to 65 years of age
- Presence of persistent asthma for at least 6 months according to GINA 2011 guidelines at step 3 or 4 of treatment who has been on stable controller therapy for at least 4 weeks, and symptoms are not sufficiently controlled with medium to high doses of inhaled corticosteroid (ICS) (>250 to ≤1000 µg/day fluticasone or equivalent) in combination with or without long acting beta agonist (LABA), insufficient control will be based on asthma control questionnaire (ACQ) score ≥1.5 points. Use of stable doses of other controller therapies according to GINA steps 3 and 4 (leukotriene modifiers, sustained release theophylline) are also acceptable, but NOT treatment with anti immunoglobulin E (IgE) antibodies within the past 6 months
- Stable but insufficiently controlled baseline conditions as documented by ACQ ≥1.5 at the screening and the baseline visits.
- Positive skin prick test (SPT) or radioallergosorbent test (RAST) to at least 1 aero-allergen during the screening period
Show all 10Show fewer
- Forced expiratory volume in one second (FEV1)≥40 to ≤90% of predicted value
- Reversibility of airway obstruction as demonstrated by:
- FEV1 improvement by >12% , and
- By ≥200 mL after inhaled β2-agonist (400 µg salbutamol or equivalent). If a subject does not meet reversibility criteria at the screening visit, reversibility may be retested once prior to run-in as long as the test is performed at least 5 days prior to the beginning of the run-in phase
Who cannot join
- Failure to meet at least 80% compliance with completion of asthma symptoms and medication diaries at the baseline visit, after initial instruction at the screening visit and where necessary additional training at the 2-weeks run-in visit. . An additional maximum 2-weeks training period may be added in such patients.
- Treatment or hospitalization for asthma exacerbation within past 2 months.
- Current use or use of systemic corticosteroids within past 2 months.
- Current smokers.
- Ex-smokers with a smoking history of >10 pack years (1 package per day for 10 years).
- Pregnancy or female planning to become pregnant during the study period.
Show all 13Show fewer
- Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
- Treatment with IgE antibodies (Xolair®) within past 6 months.
- Use of investigational unapproved drugs within 30 days or within 5 half-lives of the investigational drug, whichever is longer, or planned use during the whole study period.
- Use of investigational biologics within the last 6 months.
- Previous participation in a clinical study with a virus like particle (VLP) Qb-based vaccine.
- Possible dependency of the patient on sponsor and/or investigator.
- Women of child bearing potential
Trial locations and contacts
34 sites in 8 countries.
34 sites in 8 countries
United States21 sites
Cytos Investigator Sites
Albany, Georgia
Cytos Investigator Sites
Bangor, Maine
Cytos Investigator Sites
Bethesda, Maryland
Cytos Investigator Sites
Cincinnati, Ohio
Cytos Investigator Sites
Colorado Springs, Denver, Colorado
Cytos Investigator Sites
Eugene, Medford, Oregon
Cytos Investigator Sites
Los Angeles, Huntington Beach, San Jose, California
Cytos Investigator Sites
Metairie, Louisiana
Cytos Investigator Sites
Miami, Tallahassee, Florida
Cytos Investigator Sites
North Dartmouth, Massachusetts
Cytos Investigator Sites
Ohmaha, Bellevue, Nebraska
Cytos Investigator Sites
Oklahoma City, Oklahoma
Cytos Investigator Sites
Providence, Warwick, Rhode Island
Cytos Investigator Sites
Richmond, Virginia
Cytos Investigator Sites
Rochester, New York
Cytos Investigator Sites
San Antonio, Texas
Cytos Investigator Sites
South Bend, Indiana
Cytos Investigator Sites
Spartanburg, Summerville, South Carolina
Cytos Investigator Sites
St Louis, Missouri
Cytos Investigator Sites
Walnut Creek, San Diego, Riverside, Fountain Valley, California
Cytos Investigator Sites
Waterbury, Connecticut
Czechia2 sites
Cytos Investigator Sites
Kyjov
Cytos Investigator Sites
Olomouc, Praha, Tabor, Ostrava, Hradec Kralove, Plzen, Brno
Germany2 sites
Cytos Investigator Sites
Bad Woerishofen, Leipzig, Magdeburg
Cytos Investigator Sites
Frankfurt aM, Delitzsch, Bonn, Berlin, Ruedersdorf
Hungary2 sites
Cytos Investigator Sites
Szazhalombatta, Komaron
Cytos Investigator Sites
Tatabanya, Szombathely, Csorna, Budapest, Balassagyarmat
Israel2 sites
Cytos Investigator Sites
Haifa, Zerifin
Cytos Investigator Sites
Rehovot, Petach Tikva, Ramat Gan, Jerusalem, Ashkelon, Afula
Russia2 sites
Cytos Investigator Sites
Tomsk,St.Petersburg,Yaroslavl,Novosibirsk,Smolensk,Barnaul
Cytos Investigator Sites
Yekaterinburg
Ukraine2 sites
Cytos Investigator Sites
Donetsk, Kharkiv, Kiew, Chernivtsi, Zaporizhzhya, Mykolayiv
Cytos Investigator Sites
Vinnytsya, Ivano-Frankivsk
Poland1 site
Cytos Investigator Sites
Slupsk, Lodz, Tarnow, Pila, Poznan, Wroclaw
About this study
Official title: 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)
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
- Being tested
- CYT003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT003Biological
7 subcutaneous injections, weekly/biweekly within 10 weeks
PlaceboBiological
7 subcutaneous injections, weekly/biweekly within 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 7 weekly/biweekly injections of a placebo buffer Receives: Biological: Placebo |
| CYT003 low dose | Experimental | 7 weekly/biweekly injections of CYT003 low dose Receives: Biological: CYT003 |
| CYT003 medium dose | Experimental | 7 weekly/biweekly injections of CYT003 medium dose Receives: Biological: CYT003 |
| CYT003 high dose | Experimental | 7 weekly/biweekly injections of CYT003 high dose Receives: Biological: CYT003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: primary endpoint missed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas B Casale, Professor, Study chair, Creighton University, Omaha (NE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673672
- Sponsor's protocol ID
- CYT003-QbG10 12
- Other IDs
- 2012-003070-39
- Status last verified
- May 2014
- First submitted
- 23 Aug 2012
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01673672
- Acronym / sponsor ID
- CYT003-QbG10 12
- Conditions
- Moderate to Severe Allergic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: primary endpoint missed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo7 weekly/biweekly injections of a placebo buffer |
| CYT003 low dose | Experimental | Biological: CYT0037 weekly/biweekly injections of CYT003 low dose |
| CYT003 medium dose | Experimental | Biological: CYT0037 weekly/biweekly injections of CYT003 medium dose |
| CYT003 high dose | Experimental | Biological: CYT0037 weekly/biweekly injections of CYT003 high dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to provide written informed consent
- Able and willing to complete all protocol requirements
- Between 18 to 65 years of age
- Presence of persistent asthma for at least 6 months according to GINA 2011 guidelines at step 3 or 4 of treatment who has been on stable controller therapy for at least 4 weeks, and symptoms are not sufficiently controlled with medium to high doses of inhaled corticosteroid (ICS) (>250 to ≤1000 µg/day fluticasone or equivalent) in combination with or without long acting beta agonist (LABA), insufficient control will be based on asthma control questionnaire (ACQ) score ≥1.5 points. Use of stable doses of other controller therapies according to GINA steps 3 and 4 (leukotriene modifiers, sustained release theophylline) are also acceptable, but NOT treatment with anti immunoglobulin E (IgE) antibodies within the past 6 months
- Stable but insufficiently controlled baseline conditions as documented by ACQ ≥1.5 at the screening and the baseline visits.
Key exclusion criteria (13 listed)
- Failure to meet at least 80% compliance with completion of asthma symptoms and medication diaries at the baseline visit, after initial instruction at the screening visit and where necessary additional training at the 2-weeks run-in visit. . An additional maximum 2-weeks training period may be added in such patients.
- Treatment or hospitalization for asthma exacerbation within past 2 months.
- Current use or use of systemic corticosteroids within past 2 months.
- Current smokers.
- Ex-smokers with a smoking history of >10 pack years (1 package per day for 10 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT0037 subcutaneous injections, weekly/biweekly within 10 weeks | Biological | CYT003 high dose, CYT003 low dose, CYT003 medium dose |
| Placebo7 subcutaneous injections, weekly/biweekly within 10 weeks | Biological | Placebo |
Primary outcome
Asthma Control Questionnaire
Time frame: 1 year
Results and safety
The study was stopped early (reason given: primary endpoint missed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas B Casale, Professor study chair
Creighton University, Omaha (NE)
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT003 in people with Moderate to Severe Allergic Asthma, run by Cytos Biotechnology AG at 34 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Czechia, Germany, Hungary, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: primary endpoint missed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.