Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02477332
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

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

Interventions

  • QGE031 — BIOLOGICAL
  • Omalizumab — BIOLOGICAL
  • Placebo — OTHER

Study Details

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

Key Dates

Start date
Jul 15, 2015
Status verified
Oct 2018
Primary completion
Nov 2, 2016
Completion
Jun 12, 2017

Study Design

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

Arms

  • Experimental: QGE031 24 mg s.c. q4w
    ligelizumab 24 mg injection subcutaneous every 4 weeks
  • Experimental: QGE031 72 mg s.c. q4w
    ligelizumab 72 mg injection subcutaneous every 4 weeks
  • Experimental: QGE031 240 mg s.c. q4w
    ligelizumab 240 mg injection subcutaneous every 4 weeks
  • Active Comparator: Omalizumab 300 mg s.c. q4w
    omalizumab 300 mg injection subcutaneous every 4 weeks
  • Placebo Comparator: Placebo s.c. q4w
    placebo injection subcutaneous every 4 weeks
  • Experimental: QGE031 120 mg s.c. s.d.
    ligelizumab 120 mg injection subcutaneous single dose

Primary Outcome Measure

Percentage of Participants With Complete Hives Response (HSS7=0) [ Time Frame: Week 12 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteBirminghamAlabama35209-
Novartis Investigative SiteScottsdaleArizona85251-
Novartis Investigative SiteLittle RockArkansas72205-
Novartis Investigative SiteHuntington BeachCalifornia92647-
Novartis Investigative SiteMission ViejoCalifornia92691-
Novartis Investigative SiteSarasotaFlorida34233-
Novartis Investigative SiteEvansvilleIndiana47713-
Novartis Investigative SiteLouisvilleKentucky40291-
Novartis Investigative SiteOwensboroKentucky42301-
Novartis Investigative SiteWaldorfMaryland20602-
Novartis Investigative SiteMinneapolisMinnesota55402-
Novartis Investigative SiteRochesterMinnesota55905-
Novartis Investigative SiteSt LouisMissouri63141-
Novartis Investigative SiteForest HillsNew York11375-
Novartis Investigative SiteThe BronxNew York10461-
Novartis Investigative SiteAshevilleNorth Carolina28801-
Novartis Investigative SiteCincinnatiOhio45231-
Novartis Investigative SiteToledoOhio43617-
Novartis Investigative SiteLake OswegoOregon97035-
Novartis Investigative SiteProvidenceRhode Island02906-
Novartis Investigative SiteDallasTexas75230-
Novartis Investigative SiteFort WorthTexas76132-
Novartis Investigative SiteKatyTexas77450-
Novartis Investigative SiteSouth BurlingtonVermont05403-
Novartis Investigative SiteSpokaneWashington99204-

Find similar trials in Birmingham, AL

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Novartis Investigative Site· Birmingham, ALNovartis Investigative Site· Scottsdale, AZNovartis Investigative Site· Little Rock, ARNovartis Investigative Site· Huntington Beach, CANovartis Investigative Site· Mission Viejo, CANovartis Investigative Site· Sarasota, FL

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