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

Description

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.

Study Start Date

July 2015

Estimated Completion Date

March 2017

Interventions

  • Biological: QGE031
  • Other: Placebo
  • Biological: Omalizumab
  • Biological: Placebo

Specialties

  • Family Medicine: Dermatology
  • Dermatology: Clinical Pharmacology,Derm Allergy/Immunology
  • Physician Assistant: Dermatology

MeSH Terms

  • Hypersensitivity, Immediate
  • Omalizumab
  • Pharmacologic Actions
  • Skin Diseases, Vascular
  • Urticaria

Study ID

Novartis -- CQGE031C2201

Status

Unknown

Trial ID

NCT02477332

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

360

Sponsor

Novartis

Inclusion Criteria

  • Diagnosis of chronic spontaneous urticaria for at least 6 months
  • Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Exclusion Criteria

  • Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
  • Evidence of parasitic infection
  • Any other skin diseases than chronic spontaneous urticaria with chronic itching
  • Previous treatment with omalizumab or QGE031
  • Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
  • History of anaphylactic shock
  • History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
  • History of hypersensitivity to any of the study drugs or its components of similar chemical classes
  • Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (29)

Study Location Distance Name Phone Email
Novartis Investigative Site - Bronx, New York 40.3 miles None None None
Novartis Investigative Site - Rockville Centre, New York 43.4 miles None None None
Novartis Investigative Site - Forest Hills, New York 46.3 miles None None None
Novartis Investigative Site - Verona, New Jersey 50.6 miles None None None
Novartis Investigative Site - Skillman, New Jersey 94.1 miles None None None
Novartis Investigative Site - Providence, Rhode Island 105.4 miles None None None
Novartis Investigative Site - South Burlington, Vermont 224.7 miles None None None
Novartis Investigative Site - Waldorf, Maryland 266.8 miles None None None
Novartis Investigative Site - Toledo, Ohio 544.0 miles None None None
Novartis Investigative Site - Cincinnati, Ohio 612.0 miles None None None
Novartis Investigative Site - Indianapolis, Indiana 677.4 miles None None None
Novartis Investigative Site - Louisville, Kentucky 691.2 miles None None None
Novartis Investigative Site - Owensboro, Kentucky 781.4 miles None None None
Novartis Investigative Site - Evansville, Indiana 795.2 miles None None None
Novartis Investigative Site - Birmingham, Alabama 918.2 miles None None None
Novartis Investigative Site - St. Louis, Missouri 929.1 miles None None None
Novartis Investigative Site - Rochester, Minnesota 997.5 miles None None None
Novartis Investigative Site - Minneapolis, Minnesota 1,042.6 miles None None None
Novartis Investigative Site - Little Rock, Arkansas 1,131.5 miles None None None
Novartis Investigative Site - Papillion, Nebraska 1,184.7 miles None None None
Novartis Investigative Site - Dallas, Texas 1,417.3 miles None None None
Novartis Investigative Site - Fort Worth, Texas 1,457.4 miles None None None
Novartis Investigative Site - Katy, Texas 1,489.2 miles None None None
Novartis Investigative Site - Scottsdale, Arizona 2,176.4 miles None None None
Novartis Investigative Site - Spokane, Washington 2,201.6 miles None None None
Novartis Investigative Site - Portland, Oregon 2,463.3 miles None None None
Novartis Investigative Site - Lake Oswego, Oregon 2,470.9 miles None None None
Novartis Investigative Site - Mission Viejo, California 2,471.9 miles None None None
Novartis Investigative Site - Huntington Beach, California 2,486.4 miles None None None

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