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Active, Not Recruiting

NCT Number: NCT06966479

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion Cidea, CABA, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completion of the VALIANT study (UPB-CP-04 [NCT06196879]) per protocol.
  • 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.
  • Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion criteria

  • 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.
  • 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.
  • 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).
  • 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.
  • Participants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor.
  • 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.

Treatment and study plan

Verekitug

Drug

Verekitug subcutaneous injection.

Other names: UPB-101

Placebo

Drug

Verekitug matching placebo.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Annualized Asthma Exacerbation Rate (AAER)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Upstream Bio Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 11, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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