RECRUITING

A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)

Conditions

Severe Asthma UPB-101 Verekitug TSLP receptor monoclonal antibody VALIANT VALOUR Respiratory Tract Diseases Bronchial Diseases Asthma Lung Diseases Uncontrolled Asthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2025-05-21

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06966479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)

CONTACT

888-446-3130

clinicaltrials@upstreambio.com

Principal Investigator

James C Lee, MD

STUDY_DIRECTOR

Upstream Bio

Study Locations (Sites)

Edward Jenner Research Group, LLC

Plantation, Florida, 33317

United States

Clinical Site Partners dba Flourish research

Winter Park, Florida, 32789

United States

Collaborators and Investigators

Sponsor: Upstream Bio Inc.

James C Lee, MD, STUDY_DIRECTOR, Upstream Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-21

Study Completion Date2027-09

Study Record Updates

Study Start Date2025-05-21

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

UPB-101
Verekitug
TSLP receptor
monoclonal antibody
VALIANT
VALOUR
Respiratory Tract Diseases
Bronchial Diseases
Asthma
Lung Diseases
Uncontrolled Asthma

Additional Relevant MeSH Terms

Severe Asthma