Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

Part of paid clinical trials in Costa Mesa, California.

Sponsor
AbbVie
Study ID
NCT02443298
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • placebo — DRUG
    Matching placebo for risankizumab
  • risankizumab — DRUG
    Monoclonal IgG antibody

Study Details

The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).

Key Dates

Start date
Jun 23, 2015
Status verified
Mar 2019
Primary completion
Oct 13, 2017
Completion
Feb 2, 2018

Study Design

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

Arms

  • Experimental: Risankizumab
    Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20).
  • Placebo Comparator: Placebo
    Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20).

Primary Outcome Measure

Time to First Asthma Worsening During the Planned 24 Week Treatment Period [ Time Frame: 24 weeks ]

Locations (20)

FacilityCityStateZIPSite coordinators
WCCT Global, LLCCosta MesaCalifornia92626-
El Camino HospitalMountain ViewCalifornia94040-
IMMUNOe Research CentersCentennialColorado80112-
Yale New Haven HospitalNew HavenConnecticut06504-
Clinical Research Trials of Florida, Inc.TampaFlorida33607-
Northwestern UniversityChicagoIllinois60611-
Johns Hopkins HospitalBaltimoreMaryland21224-
Brigham and Women's HospitalBostonMassachusetts02115-
Washington University School of MedicineSt LouisMissouri63110-
VA WNY Healthcare SystemBuffaloNew York14215-
American Health Research, Inc.CharlotteNorth Carolina28207-
Coastal Carolina Health Care, P.A.New BernNorth Carolina28562-
Wake Forest School of MedicineWinston-SalemNorth Carolina27104-
Temple University School of MedicinePhiladelphiaPennsylvania19140-
Research Protocol Mgmt SpcPittsburghPennsylvania15243-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
MedTrial, LLCColumbiaSouth Carolina29204-
VitaLink ResearchGreenvilleSouth Carolina29615-
Respiratory and Sleep Disorders SpecialistsThe WoodlandsTexas77380-
O and O Alpan, LLCFairfaxVirginia22030-

Find similar trials in Costa Mesa, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
WCCT Global, LLC· Costa Mesa, CAEl Camino Hospital· Mountain View, CAIMMUNOe Research Centers· Centennial, COYale New Haven Hospital· New Haven, CTClinical Research Trials of Florida, Inc.· Tampa, FLNorthwestern University· Chicago, IL

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