A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

NCT06196879
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
479
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Lead sponsor
Upstream Bio Inc.
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Start date
2024-02-27
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Number of sites
155
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Summary
The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.
clinicaltrials.gov
Short title
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
clinicaltrials.gov
Official title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-03-19
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First posted
2024-01-09
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Registry last updated
2026-05-01
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Primary completion date
2025-12-16
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Start date
2024-02-27
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Actual participants
479
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Participants
479
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Participant count basis
Actual
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Protocol amendments
5
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Randomisation ratio
1:1:1:1
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Number of sites
155
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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
NCT06196879
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ClinicalTrials.gov ID
NCT06196879
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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. Annual Asthma Exacerbation Rate (AAER)

    Timeframe: 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.

  1. Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) to Week 60

    Timeframe: 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.

  2. Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60

    Timeframe: Baseline to Week 60

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

  3. Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) to Week 60

    Timeframe: 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.

  4. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

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

  • Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
  • Age 18 to 80 years of age (inclusive) at the time of consent.
  • Physician-diagnosed asthma for at least 12 months prior to Visit 1.
  • Participant has evidence of bronchodilator (BD) reversibility as documented by either historical reversibility (within 12 months prior to study entry) or reversibility during screening.
  • Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months.
  • Documented history of asthma exacerbation(s) within 12 months of Visit 1.
  • Asthma Control Questionnaire-6 (ACQ-6) score greater than or equal to (>=) 1.5 at screening and randomization.
  • Participant must have a pre-BD FEV1 value of >=30 percent (%) and <=80% predicted at Screening.
  • Minimum compliance with daily diary and background asthma medication(s) as captured in the daily diary during the Run-in Period.
  • Agrees to follow the required contraceptive techniques/methods.
  • Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last.

  • Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1 or during the Screening/Run-in Period.
  • Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients.
  • Previous biologics, including those for asthma treatment, for which the appropriate washout period is not fulfilled prior to Visit 1. If the half-life is not known, a 24-week washout period prior to Visit 1 should be applied.
  • Allergen immunotherapy (unless maintenance dose) within 12 weeks prior to Visit 1 or plans to begin therapy or change dosing during the study.
  • For participants taking oral corticosteroids (OCS), the dose has not been stable for at least 2 weeks prior to Visit 1 and/or is >10 milligram (mg) daily, or >20 mg every other day.
  • Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit 1.
  • History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy.
  • Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuff users or participants with a smoking history >=10 pack years. (Former nicotine smokers with a smoking history of <10 pack years, former nicotine vapers and former snuff users must have stopped for at least 6 months prior to Visit 1 to be eligible).
  • Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tract symptoms within 28 days before Visit 1.
  • 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.
Sources for eligibility
clinicaltrials.gov

  • AllerVie Clinical ResearchBirmingham, United States
  • Kern Research, Inc.Bakersfield, United States
  • Velocity Clinical Research - Lafayette LALos Angeles, United States
  • Newport Native MD IncNewport Beach, 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
  • Woodland Clinic Medical GroupWoodland, United States
  • National Jewish HealthDenver, United States
  • Advance Pharma ResearchCutler Bay, United States
  • Unique Clinical TrialsDoral, United States
  • Health and Life Research Institute, LLCMiami, United States
  • Phoenix Medical ResearchMiami, United States
  • Research Institute of South FloridaMiami, United States
  • Nouvelle Clinical ResearchMiami, United States
  • Anderson Allergy And Asthma, PAOrlando, United States
  • Edward Jenner Research Group, LLCPlantation, United States
  • R&B Medical CenterTampa, United States
  • Clinical Site Partners dba Flourish researchWinter Park, United States
  • Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United States
  • Pivotal Research SolutionsStonecrest, United States
  • RNA America Health SciencesSugar Hill, United States
  • Treasure Valley Medical ResearchBoise, United States
  • Velocity Clinical Research - MeridianMeridian, United States

And 130 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-507410-27-00
Sources for references
clinicaltrials.gov

Related records

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Lead sponsors (1)

Conditions (3)