The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
436
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From VALOUR baseline up to Week 64
Annualized Asthma Exacerbation Rate (AAER)
An asthma exacerbation is defined as a worsening of asthma that required treatment with systemic (oral or intravenous) corticosteroids for at least three consecutive days or a single depo-injectable dose of corticosteroids or an emergency room (ER) or urgent care visit that required systemic corticosteroids or an admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for greater than or equal to 24 hours.
Time frame: From VALOUR baseline up to Week 60
Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Spirometry will be performed pre-bronchodilator (BD) to measure lung function. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Time frame: From VALOUR baseline to Week 60
Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Standardized single breath FeNO test is performed to evaluate airway inflammation.
Time frame: From VALOUR baseline up to Week 60
Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6)
ACQ-6 is a participant-reported questionnaire to assess asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kern Research, Inc.
Bakersfield, California, United States
RECRUITINGCalifornia Medical Research Associates Inc.
Northridge, California, United States
RECRUITINGIntegrated Research of Inland Inc
Upland, California, United States
RECRUITINGAllianz Research Institute
Westminster, California, United States
RECRUITINGPhoenix Medical Research
Miami, Florida, United States
RECRUITINGResearch Institute of South Florida
Miami, Florida, United States
RECRUITINGHealth and Life Research Institute, LLC
Miami, Florida, United States
RECRUITINGNouvelle Clinical Research
Miami, Florida, United States
RECRUITINGEdward Jenner Research Group, LLC
Plantation, Florida, United States
RECRUITINGR&B Medical Center
Tampa, Florida, United States
RECRUITING...and 47 more locations
Time frame: From VALOUR baseline to Week 60