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

Part of paid clinical trials in Bakersfield, California.

Sponsor
Upstream Bio Inc.
Study ID
NCT06966479
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Verekitug — DRUG
    Verekitug subcutaneous injection.
  • Placebo — DRUG
    Verekitug matching placebo.

Study Details

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).

Key Dates

First listed
May 11, 2025
Start date
May 21, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
396 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Verekitug 100 mg Q12W and Placebo
    Participants will receive 0.5 mL of verekitug (100 mg) and 2.0 mL of matching placebo, subcutaneous (SC) injections, every 12 weeks (Q12W) for up to 48 weeks.
  • Experimental: Verekitug 400 mg Q24W and Placebo
    Participants will receive 2.0 mL of verekitug (400 mg) and 0.5 mL of matching placebo, SC injections, at Weeks 24 and 48 visits. Participants will also receive 2.0 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From VALOUR baseline up to Week 64 ]

Locations (28)

FacilityCityStateZIPSite coordinators
Kern Research, Inc.BakersfieldCalifornia93301-
California Medical Research Associates Inc.NorthridgeCalifornia91324-
Integrated Research of Inland IncUplandCalifornia91786-
Allergy & Asthma Clinical ResearchWalnut CreekCalifornia94598-
Allianz Research InstituteWestminsterCalifornia92683-
Advance Pharma ResearchCutler BayFlorida33189-
Clinical Site Partners, LLC dba Flourish ResearchMiamiFlorida33135-
Health and Life Research Institute, LLCMiamiFlorida33176-
Nouvelle Clinical ResearchMiamiFlorida33189-
Phoenix Medical ResearchMiamiFlorida33165-
Research Institute of South FloridaMiamiFlorida33173-
Edward Jenner Research Group, LLCPlantationFlorida33317-
R&B Medical CenterTampaFlorida33614-
Clinical Site Partners dba Flourish researchWinter ParkFlorida32789-
Treasure Valley Medical ResearchBoiseIdaho83706-
Chesapeake Clinical Research IncWhite MarshMaryland21162-
Pulmonary Research Institute of Southeast Michigan (PRISM)Farmington HillsMichigan48336-
AA MRCFlintMichigan48504-
M3 Wake ResearchLas VegasNevada89106-
Urban Health Plan INCThe BronxNew York10459-
Toledo Institute of Clinical Research IncToledoOhio43617-
OK Clinical Research, LLCEdmondOklahoma73034-
Horizon Clinical ResearchCypressTexas77429-
Alina Clinical Trials, LLCDallasTexas75209-
El Paso Pulmonary AssociationEl PasoTexas79902-
California Medical Research Associates Inc.HoustonTexas77008-
Metroplex Pulmonary and Sleep Center DriveMcKinneyTexas75069-
DM Clinical TomballTomballTexas77375-

Find similar trials in Bakersfield, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Kern Research, Inc.· Bakersfield, CACalifornia Medical Research Associates Inc.· Northridge, CAIntegrated Research of Inland Inc· Upland, CAAllergy & Asthma Clinical Research· Walnut Creek, CAAllianz Research Institute· Westminster, CAAdvance Pharma Research· Cutler Bay, FL

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