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Evaluating verekitug for severe asthma treatment

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)

Phase 2 Interventional Upstream Bio Inc. · NCT06196879

This study is testing a new treatment called verekitug to see if it can help adults with severe asthma breathe better and reduce asthma attacks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment436 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorUpstream Bio Inc. Industry-sponsored
Drugs / interventionsimmunotherapy
Locations148 sites (Birmingham, Alabama and 147 other locations)
Trial IDNCT06196879 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of verekitug (UPB-101) in adults with severe asthma. It is a multicenter, randomized, placebo-controlled trial involving approximately 436 participants who will receive either verekitug or a placebo through subcutaneous injections. The study will assess the incidence of asthma exacerbations, lung function, and overall asthma control over a treatment period of up to 60 weeks. Participants will be monitored for safety and tolerability throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a history of severe asthma and documented treatment with inhaled corticosteroids.

Not a fit: Patients with mild asthma or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce asthma exacerbations and improve overall asthma management for patients.

How similar studies have performed: Other studies have shown promise with similar biologic approaches for severe asthma, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Birmingham, Alabama and 147 other locations

+98 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe AsthmaVALIANTRespiratory Tract DiseasesBronchial DiseasesAsthmaLung DiseasesUncontrolled Asthma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.