A Study to Test if TEV-48574 is Effective in Relieving Asthma

Phase 1

Conditions: T2-low/non-T2 Severe Uncontrolled Asthma
MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2020-001927-15-BG

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 124

Inclusion Criteria

a. The patient is a man or woman of any ethnic origin, at least 18 years of age at the time of signature of the informed consent form (ICF).
b. The patient has a diagnosis of asthma for at least 12 months prior to the initial screening visit.
e. The patient has demonstrated =12% and =200mL response to a bronchodilator from baseline FEV1 within 30 minutes after 4 inhalations of albuterol/salbutamol HFA MDI (90 mcg ex-actuator) or equivalent (eg, Ventolin) at screening.
f. The patient has asthma with a FEV1 =30% and <80% of the value predicted for age, height, sex, and race at screening. FEV1 must be performed using the office-based spirometer provided for the study. One pulmonary function test retest during the screening visit(s) period (up to 2 weeks) is allowed to fulfill this criterion.
For further inclusion criteria, see protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 109
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

a. The patient has any other pulmonary diagnosis that in the opinion of the investigator and/or the clinical study physician could adversely affect patient safety or interpretation of study results. Examples include but are not limited to: chronic obstructive pulmonary disease, chronic bronchitis, or any respiratory condition that requires any chronic antibiotic use (some antibiotics can be immunomodulatory such as macrolides [eg, erythromycin, azithromycin and clarithomycin]), bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia, and interstitial lung disease (including eosinophilic granulomatosis with polyangiitis [EGPA] which is expressly prohibited), obstructive sleep apnea (sometimes referred to as sleep apnea or Pickwickian Syndrome), and gastroesophageal reflux disease that is not treated with a proton pump inhibitor on a scheduled treatment regimen (not as needed).
b. The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician.
c. The patient has any of the following medical conditions:
- Conditions that may mimic asthma (eg, vocal cord dysfunction, hyperventilation, panic attacks, cardiac asthma, uncontrolled gastroesophageal reflux disease [gastroesophageal reflux disease controlled on a stable proton pump inhibitor regimen for at least 1 month may be allowed])
- Conditions of immunodeficiency, immunocompromise, and/or conditions requiring immunomodulatory therapy
- A history of malignancy within 5 years before screening (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening)
- Tested positive for tuberculosis (TB) at screening by the QuantiFERON® TB Gold Test, or had a history of untreated latent or active TB. If the QuantiFERON® TB Gold Test is deemed by the principal investigator to be a false positive, a repeat specimen shall be submitted; if the second test is
also positive, the patient screen fails; if the second test is negative, a third test shall be submitted; if the third test agrees with the first test, the patient screen fails; if the third test agrees with second test, the patient is considered
to be negative for TB;
- Known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening
- A history of more than one herpes zoster episode or multimetameric herpes zoster
- A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, aspergillosis, Clostridium difficile)
- A history of or ongoing chronic or recurrent infectious disease (eg, infected indwelling prosthesis, osteomyelitis, chronic sinusitis)
- A suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the initial screening visit. Note: Patients who develop an upper respiratory infection/lower respiratory infection (URI/LRI) during the screening period may rescreen 2 weeks after symptoms resolve subject to local or regional public health directives.
- Patients with clinical symptoms that may indicate COVID-19 infection, and/or patients who in the investigator’s opinion were at high risk of exposure to COVID-19 within

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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