Severe Asthma
Conditions
Keywords
UPB-101, Verekitug, TSLP receptor, monoclonal antibody, VALIANT, VALOUR, Respiratory Tract Diseases, Bronchial Diseases, Asthma, Lung Diseases, Uncontrolled Asthma
Brief summary
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).
Interventions
DRUGVerekitug
Verekitug subcutaneous injection.
DRUGPlacebo
Verekitug matching placebo.
Sponsors
Upstream Bio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Completion of the VALIANT study (UPB-CP-04 \[NCT06196879\]) per protocol. 2. Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study. 3. Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
1. Abnormal medical history, physical finding, or safety finding that in the opinion of the Investigator may obscure the study data or interfere with the participant's safety. 2. Any clinical laboratory test result outside of the reference ranges considered by the Investigator as clinically significant and that may obscure the study data or interfere with the participant's safety. 3. Participant with a history or evidence of a clinically significant pulmonary condition (other than asthma), including significant restrictive findings on pulmonary function testing, chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, or any other related condition that may obscure the study data (e.g., gastroesophageal reflux and vocal cord paralysis/dysfunction). 4. Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active. 5. Participants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor. 6. Participant is unreliable, incapable of adhering to the protocol and visit schedule according to the judgment of the Investigator or has any disorder that may compromise their ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From VALOUR baseline up to Week 64 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6) | From VALOUR baseline to Week 60 | 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. |
| Annualized Asthma Exacerbation Rate (AAER) | From VALOUR baseline up to Week 60 | 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. |
| Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1) | From VALOUR baseline to Week 60 | 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. |
| Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO) | From VALOUR baseline up to Week 60 | Standardized single breath FeNO test is performed to evaluate airway inflammation. |
Countries
Argentina, Bulgaria, Canada, Chile, Czechia, Germany, Italy, Japan, Poland, South Africa, South Korea, Spain, Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORJustin Salciccioli, MD
Upstream Bio
Outcome results
None listed