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

NCT06966479
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
396
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Lead sponsor
Upstream Bio Inc.
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Start date
2025-05-21
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Number of sites
102
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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).
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Short title
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
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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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-09-01
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First posted
2025-05-11
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Registry last updated
2026-05-14
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Primary completion date
2027-09-01
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Start date
2025-05-21
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Actual participants
396
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Participants
396
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
102
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Upstream Bio Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06966479
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ClinicalTrials.gov ID
NCT06966479
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: 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.

  1. Annualized Asthma Exacerbation Rate (AAER)

    Timeframe: 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.

  2. Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1)

    Timeframe: 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.

  3. Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO)

    Timeframe: From VALOUR baseline up to Week 60

    Standardized single breath FeNO test is performed to evaluate airway inflammation.

  4. Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6)

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.
Sources for eligibility
clinicaltrials.gov

  • Kern Research, Inc.Bakersfield, United States
  • California Medical Research Associates Inc.Northridge, United States
  • Integrated Research of Inland IncUpland, United States
  • Allergy & Asthma Clinical ResearchWalnut Creek, United States
  • Allianz Research InstituteWestminster, United States
  • Advance Pharma ResearchCutler Bay, United States
  • Clinical Site Partners, LLC dba Flourish ResearchMiami, United States
  • Phoenix Medical ResearchMiami, United States
  • Research Institute of South FloridaMiami, United States
  • Health and Life Research Institute, LLCMiami, United States
  • Nouvelle Clinical ResearchMiami, United States
  • Edward Jenner Research Group, LLCPlantation, United States
  • R&B Medical CenterTampa, United States
  • Clinical Site Partners dba Flourish researchWinter Park, United States
  • Treasure Valley Medical ResearchBoise, United States
  • Chesapeake Clinical Research IncWhite Marsh, United States
  • Pulmonary Research Institute of Southeast Michigan (PRISM)Farmington Hills, United States
  • AA MRCFlint, United States
  • M3 Wake ResearchLas Vegas, United States
  • Urban Health Plan INCThe Bronx, United States
  • Toledo Institute of Clinical Research IncToledo, United States
  • OK Clinical Research, LLCEdmond, United States
  • Horizon Clinical ResearchCypress, United States
  • Alina Clinical Trials, LLCDallas, United States
  • El Paso Pulmonary AssociationEl Paso, United States

And 77 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-519469-23-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)