A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria

Completed · Phase 4 · Has a placebo group

Conditions studied: Urticaria

In brief

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.

Key facts

Study ID

NCT02392624

Run by

Genentech, Inc.

People needed

206

Starts

2015-05-18

Expected to finish

2017-03-09

Last updated by the study team

2018-03-29

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CIU refractory to H1 antihistamines at baseline
• Presence of itch and hives for at least 8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment (up to four times the approved dose) during this time period
• UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to baseline
• Participants must have been on a non-sedating H1 antihistamine treatment (up to four times the approved dose) for CIU for at least 3 consecutive days immediately prior to screening visit with continued current use on the day of the initial screening visit
• CIU diagnosis for ≥ 6 months
• Willing and able to complete a daily symptom eDiary for the duration of the study

You may not qualify if…

• Treatment with an investigational agent within 30 days of the initial screening visit
• Body weight less than 20 kilograms
• Clearly defined underlying etiology for chronic urticarias other than CIU
• Evidence of a parasitic infection
• Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch
• Previous treatment with omalizumab within 1 year prior to the initial screening visit
• Participants may not have taken during treatment period or have been taking within 30 days before the initial screening visit any of the following medications or treatments:
• regular (daily/every other day during 5 or more consecutive days) systemic corticosteroids, hydroxychloroquine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G or plasmapheresis
• Regular (daily/every other day) oral doxepin use within 14 days prior to the initial screening visit
• Pregnant or lactating women, or women intending to become pregnant during the study

Where it is running

• Allergy and Asthma Relief Experts — Granada Hills, California, United States
• Allergy & Asthma Care Center of Southern California — Long Beach, California, United States
• Dermatology Research Associate — Los Angeles, California, United States
• Southern California Research Center — Mission Viejo, California, United States
• Choc Psf, Amc — Orange, California, United States
• Allergy & Asthma Consultants — Redwood City, California, United States
• Allergy and Asthma Clinical Research, Inc. — Walnut Creek, California, United States
• IMMUNOe Research Centers — Centennial, Colorado, United States
• Colorado Allergy & Asthma Centers, Pc — Denver, Colorado, United States
• Florida Center for Allergy and Asthma Research — Aventura, Florida, United States
• Florida Ctr-Allergy & Asthma — Miami, Florida, United States
• Sarasota Clinical Research — Sarasota, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Clinical Research Center of Southern Illinois LLC — Shiloh, Illinois, United States
• Deaconess Clinic — Evansville, Indiana, United States
• Dawes Fretzin Clinical Res LLC — Indianapolis, Indiana, United States
• Abraham Research PLLC — Fort Mitchell, Kentucky, United States
• Dermatology Specialists Research, LLC — Louisville, Kentucky, United States
• Allergy & Asthma Specialists, PSC — Owensboro, Kentucky, United States
• Asthma, Allergy & Sinus Center — Baltimore, Maryland, United States
• Institute for Asthma & Allergy — Chevy Chase, Maryland, United States
• Respiratory Medicine Research; Institue of Michigan P.L.C. — Ypsilanti, Michigan, United States
• James Q. Del Rosso, DO, LLC — Las Vegas, Nevada, United States
• Ocean Allergy & Resp Res Ctr — Brick, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States

Full record on ClinicalTrials.gov

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