Clinical trial NCT06966479: A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
Official title: A Long-Term Extension Study to Evaluate Safety and Efficacy of Verekitug (UPB-101) in Adult Participants With Severe Asthma Who Completed the VALIANT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Severe Asthma
Keywords: UPB-101
Verekitug
TSLP receptor
monoclonal antibody
VALIANT
VALOUR
Respiratory Tract Diseases
Bronchial Diseases
Asthma
Lung Diseases
Uncontrolled Asthma
Lead sponsor: Upstream Bio Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-11
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From VALOUR baseline up to Week 64
Secondary outcomes:
measure: Annualized Asthma Exacerbation Rate (AAER)
timeFrame: From VALOUR baseline up to Week 60
measure: Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: From VALOUR baseline to Week 60
measure: Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: From VALOUR baseline up to Week 60
measure: Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6)
timeFrame: From VALOUR baseline to Week 60
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Edward Jenner Research Group, LLC
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners dba Flourish research
state: Florida
Study officials:
affiliation: Upstream Bio
name: James C Lee, MD
role: STUDY_DIRECTOR
References: