- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Tampa, Florida, Forenede Stater, 33612-4799
- University of South Florida
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: CYT003
Injections of CYT003
|
Injections
|
|
Placebo komparator: Placebo
Injections of placebo
|
Injections
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Astma-kontrolspørgeskema (ACQ)
Tidsramme: 12 uger
|
12 uger
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Thomas Casale, MD, University of South Florida
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CYT003-QbG10 13
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Kliniske forsøg med CYT003
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Cytos Biotechnology AGAfsluttetFlerårig allergi over for husstøvmide og/eller katEstland, Letland, Litauen
-
Cytos Biotechnology AGAfsluttetHusstøvmideallergi | Flerårig Allergisk RhinoconjunctivitisSchweiz
-
Cytos Biotechnology AGAfsluttetModerat til svær allergisk astmaForenede Stater, Tjekkiet, Tyskland, Ungarn, Israel, Polen, Den Russiske Føderation, Ukraine
-
Cytos Biotechnology AGAfsluttet
-
Cytos Biotechnology AGAfsluttetRhinoconjunctivitis | AllergierEstland, Tyskland, Grækenland, Letland, Litauen, Rumænien
-
Umar FarooqMerck Sharp & Dohme LLC; University of Iowa; Checkmate PharmaceuticalsAfsluttet
-
Emory UniversityNational Cancer Institute (NCI); Prostate Cancer FoundationSuspenderetFase IV prostatakræft AJCC v8 | Metastatisk prostataadenokarcinomForenede Stater
-
University of Southern CaliforniaNational Cancer Institute (NCI)AfsluttetStadie IV Bugspytkirtelkræft AJCC v8 | Metastatisk bugspytkirteladenokarcinom | Lokalt avanceret malignt fast neoplasma | Ikke-operable malignt fast neoplasmaForenede Stater