A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD

Part of paid clinical trials in Bakersfield, California.

Sponsor
Upstream Bio Inc.
Study ID
NCT06981078
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Verekitug — DRUG
    Verekitug (UPB-101) formulated solution
  • Placebo — OTHER
    Matching Placebo to Verekitug (UPB-101)

Study Details

The purpose of this study is to assess the efficacy and safety of verekitug (UPB-101) in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), an inflammatory lung disease.

Key Dates

First listed
May 20, 2025
Start date
Jul 2, 2025
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
666 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Verekitug (UPB-101) 100 mg and Placebo
    Participants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.
  • Experimental: Verekitug (UPB-101) 400 mg and Placebo
    Participants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits.
  • Placebo Comparator: Placebo
    Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.

Primary Outcome Measure

Annualized rate of moderate or severe COPD exacerbation events [ Time Frame: From Day 1 (Baseline) up to Week 108 ]

Locations (29)

FacilityCityStateZIPSite coordinators
Kern Research Inc.BakersfieldCalifornia93301-
PulmoCrit AssociatesEncinoCalifornia91436-
Torrance Clinical Research InstituteLomitaCalifornia90717-2101-
Dream Team Clinical ResearchPomonaCalifornia91767-
Apex Clinical ResearchSan DiegoCalifornia92120-
Allianz Research InstituteWestminsterCalifornia92683-
D&H Doral Research Center, LLCDoralFlorida33122-
Qway Research, LLCHialeahFlorida33010-
Finlay Medical ResearchMiamiFlorida33126-
MplusM - ITB ResearchMiamiFlorida33173-
Florida Institute for Clinical Research,LLCOrlandoFlorida32825-
Velocity Clinical Research-Savannah - Internal MedicineSavannahGeorgia31406-
Christie Clinic, LLCChampaignIllinois61820-
Velocity Clinical Research-RockvilleRockvilleMaryland20854-
Chesapeake Clinical Research, IncWhite MarshMaryland21162-
HealthPartnersSaint PaulMinnesota55130-
American Health Research, Inc.CharlotteNorth Carolina28277-
Velocity Clinical Research, AndersonAndersonSouth Carolina29621-
SleepMed Inc.ColumbiaSouth Carolina29201-
Velocity Clinical Research, GaffneyGreenvilleSouth Carolina29615-
Velocity Clinical Research, Spartanburg - PulmonologySpartanburgSouth Carolina29303-
Velocity Clinical Research- UnionUnionSouth Carolina29379-
El Paso Pulmonary AssociationEl PasoTexas79902-
Synergy Groups Medical LLCHoustonTexas77036-
Synergy Groups Medical LLCHoustonTexas77061-
Victorium Clinical ResearchHoustonTexas77024-
Metroplex Pulmonary and Sleep CenterMcKinneyTexas75069-
Synergy Groups Medical LLCMissouri CityTexas77459-
Velocity Clinical Research - SuffolkSuffolkVirginia23435-

Find similar trials in Bakersfield, CA

Nationwide
COPD trialsPulmonology trialsLung disease trials
By condition
COPD
By specialty
PulmonologyLung disease
By research site
Kern Research Inc.· Bakersfield, CAPulmoCrit Associates· Encino, CATorrance Clinical Research Institute· Lomita, CADream Team Clinical Research· Pomona, CAApex Clinical Research· San Diego, CAAllianz Research Institute· Westminster, CA

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