CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids

NCT02087644 | Withdrawn Phase 2

• 1 other identifier: CYT003-QbG10 13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire (ACQ)

  12 weeks

Study Arms (2)

CYT003

EXPERIMENTAL

Injections of CYT003

Biological: CYT003

Placebo

PLACEBO COMPARATOR

Injections of placebo

Biological: Placebo

Interventions

CYT003 BIOLOGICAL

Injections

CYT003

Placebo BIOLOGICAL

Injections

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cytos Biotechnology AG: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612-4799, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

CYT003-QbG10

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas Casale, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 14, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (1)