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- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Florida
-
Tampa, Florida, États-Unis, 33612-4799
- University of South Florida
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: CYT003
Injections of CYT003
|
Injections
|
|
Comparateur placebo: Placebo
Injections of placebo
|
Injections
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Questionnaire de contrôle de l'asthme (ACQ)
Délai: 12 semaines
|
12 semaines
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Thomas Casale, MD, University of South Florida
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CYT003-QbG10 13
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