Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

Part of paid clinical trials in Fresno, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01716754
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • QGE031 — DRUG
    QGE031 was supplied as 120 mg liquid in vial per 1 mL
  • Omalizumab — DRUG
    Omalizumab was supplied as 150 mg lyophilisate in vial
  • Placebo — DRUG
    Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL

Study Details

This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

Key Dates

Start date
Dec 31, 2012
Status verified
Aug 2017
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016

Study Design

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

Arms

  • Experimental: QGE031 240 mg every 2 weeks (q2w)
    Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
  • Experimental: QGE031 240 mg q4w
    Participants received QGE031 240 mg s.c. q4w for 16 weeks.
  • Experimental: QGE031 180 mg q2w
    Participants received QGE031 180 mg s.c. q2w for 16 weeks.
  • Experimental: QGE031 120 mg q2w
    Participants received QGE031 120 mg s.c. q2w for 16 weeks.
  • Experimental: QGE031 36 mg q2w
    Participants received QGE031 36 mg s.c. q2w for 16 weeks.
  • Experimental: QGE031 12 mg q2w
    Participants received QGE031 12 mg s.c. q2w for 16 weeks.
  • Active Comparator: Omalizumab (as per locally approved dosing table)
    Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
  • Placebo Comparator: Placebo to QGE031 240 mg q2w
    Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
  • Placebo Comparator: Placebo to QGE031 240 mg q4w
    Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
  • Placebo Comparator: Placebo to QGE031 180 mg q2w
    Participants received QGE031 180 mg s.c. q2w for 16 weeks.
  • Placebo Comparator: Placebo to QGE031 120 mg q2w
    Participants received QGE031 120 mg s.c. q2w for 16 weeks.
  • Placebo Comparator: Placebo to QGE031 36 mg q2w
    Participants received QGE031 36 mg s.c. q2w for 16 weeks.
  • Placebo Comparator: Placebo to QGE031 12 mg q2w
    Participants received QGE031 12 mg s.c. q2w for 16 weeks.
  • Placebo Comparator: Placebo to omalizumab
    Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.

Primary Outcome Measure

Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo [ Time Frame: Week 16 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteFresnoCalifornia93720-
Novartis Investigative SiteHawaiian GardensCalifornia90716-
Novartis Investigative SiteRiversideCalifornia92506-
Novartis Investigative SiteSan JoseCalifornia95117-
Novartis Investigative SiteVistaCalifornia92083-
Novartis Investigative SiteEvansvilleIndiana47713-
Novartis Investigative SiteOwensboroKentucky42301-
Novartis Investigative SiteColumbiaMaryland21044-
Novartis Investigative SiteWaldorfMaryland20602-
Novartis Investigative SiteNoviMichigan48375-
Novartis Investigative SiteMinneapolisMinnesota55402-
Novartis Investigative SiteOmahaNebraska68130-
Novartis Investigative SitePapillionNebraska68046-
Novartis Investigative SiteBrooklynNew York11229-
Novartis Investigative SiteMineolaNew York11501-
Novartis Investigative SiteCincinnatiOhio45231-
Novartis Investigative SiteLincolnRhode Island02865-
Novartis Investigative SiteMt. PleasantSouth Carolina29464-
Novartis Investigative SiteSummervilleSouth Carolina29485-
Novartis Investigative SiteSalt Lake CityUtah84108-
Novartis Investigative SiteFairfaxVirginia22030-
Novartis Investigative SiteEverettWashington98208-

Find similar trials in Fresno, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Novartis Investigative Site· Fresno, CANovartis Investigative Site· Hawaiian Gardens, CANovartis Investigative Site· Riverside, CANovartis Investigative Site· San Jose, CANovartis Investigative Site· Vista, CANovartis Investigative Site· Evansville, IN

Related Studies