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- Klinische proef NCT02087644
CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
A Randomized, Placebo-Controlled, Phase IIb Study of CYT003-QbG10 (CYT003), a TLR9 Agonist, in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.
Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.
Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma at the time of primary endpoint and throughout the study.
Studietype
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
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Florida
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Tampa, Florida, Verenigde Staten, 33612-4799
- University of South Florida
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Provide written informed consent.
- Complete all protocol requirements.
- Between 18 to 65 years of age.
- Persistent allergic asthma patients
- Forced expiratory volume in one second (FEV1) ≥60% to ≤ 90% of predicted value
- Reversibility of airway obstruction
- Patients meeting the contraception requirements
- At baseline: Patients treated with ICS and insufficiently controlled
- Blood eosinophil count above a certain level
Exclusion Criteria:
- Failure to meet at least 80% compliance of use of the patient e-diary/ peak expiratory flow (PEF) meter (AM3 device) at the baseline visit
- 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 for less than 1 year, with a tobacco smoking history of >10 pack years
- Major surgery within 3 months prior to signing the ICF or anticipated during study
- Presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. COPD), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
- Any malignancy within the previous 5 years
- Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
- Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Presence of active infectious disease as judged by the investigator
- Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
- Pregnancy (based on positive urine test at screening visit) or lactation.
- Female planning to become pregnant during the study period.
- Patients with any history of abuse of alcohol or other recreational drugs.
- Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
- BMI >40
- Use of investigational or approved biologics/immune-modulators within the last 6 months.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: CYT003
Injections of CYT003
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Injections
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Placebo-vergelijker: Placebo
Injections of placebo
|
Injections
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Asthma Controle Vragenlijst (ACQ)
Tijdsspanne: 12 weken
|
12 weken
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Thomas Casale, MD, University of South Florida
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CYT003-QbG10 13
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