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

Urticaria Clinical Trial

Official title:

XTEND-CIU (Xolair Treatment Efficacy of Longer Duration in Chronic Idiopathic Urticaria): A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Omalizumab Through 48 Weeks in Patients With Chronic Idiopathic Urticaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392624
• Other study ID #: ML29510
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2015
• Last updated: March 26, 2018
• Start date: May 18, 2015
• Est. completion date: March 9, 2017

Study information

• Verified date: March 2018
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Urticaria

Intervention

Drug:
• Omalizumab
Omalizumab 300 mg administered SC Q4W.
• Placebo
Placebo matched to omalizumab administered SC Q4W.

Locations

Country	Name	City	State
United States	Allergy Partners of Western NC	Asheville	North Carolina
United States	Florida Center for Allergy and Asthma Research	Aventura	Florida
United States	Asthma, Allergy & Sinus Center	Baltimore	Maryland
United States	Ocean Allergy & Resp Res Ctr	Brick	New Jersey
United States	Montefiore Medical Group;Department of Medicine	Bronx	New York
United States	Allergy & Respiratory Center	Canton	Ohio
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	National Allergy and Asthma Research	Charleston	South Carolina
United States	Institute for Asthma & Allergy	Chevy Chase	Maryland
United States	Bernstein Clinical Research Center Llc	Cincinnati	Ohio
United States	Colorado Allergy & Asthma Centers, Pc	Denver	Colorado
United States	Asthma, Nasal Disease, and Allergy Research Center of New England	East Providence	Rhode Island
United States	Deaconess Clinic	Evansville	Indiana
United States	O & O Alpan, LLC	Fairfax	Virginia
United States	Abraham Research PLLC	Fort Mitchell	Kentucky
United States	Allergy and Asthma Relief Experts	Granada Hills	California
United States	Dawes Fretzin Clinical Res LLC	Indianapolis	Indiana
United States	James Q. Del Rosso, DO, LLC	Las Vegas	Nevada
United States	Live Oak Allergy & Asthma Clinic	Live Oak	Texas
United States	Allergy & Asthma Care Center of Southern California	Long Beach	California
United States	Dermatology Research Associate	Los Angeles	California
United States	Dermatology Specialists Research, LLC	Louisville	Kentucky
United States	Florida Ctr-Allergy & Asthma	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Southern California Research Center	Mission Viejo	California
United States	Choc Psf, Amc	Orange	California
United States	Allergy & Asthma Specialists, PSC	Owensboro	Kentucky
United States	Allergy & Asthma Consultants	Redwood City	California
United States	Aair Research Center	Rochester	New York
United States	University of Rochester Medical Center; University Dermatology Associates	Rochester	New York
United States	Allergy & Asthma Research Center	San Antonio	Texas
United States	Sarasota Clinical Research	Sarasota	Florida
United States	Clinical Research Center of Southern Illinois LLC	Shiloh	Illinois
United States	Timber Lane Allergy-Asth Res	South Burlington	Vermont
United States	Premier Clinical Research	Spokane	Washington
United States	University of South Florida	Tampa	Florida
United States	Toledo Inst of Clin Research	Toledo	Ohio
United States	Vital Prospects Clin Res Pc	Tulsa	Oklahoma
United States	Allergy and Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Respiratory Medicine Research; Institue of Michigan P.L.C.	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by Urticaria Activity Score Over 7 Days (UAS7) (Clinical Worsening: UAS7 Greater Than or Equal to [>/=] 12, Maintained for At Least 2 Consecutive Weeks)	Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >/=12 for at least 2 consecutive weeks post-randomization between Weeks 24 and 48.	From randomization (Week 24) to Week 48
Secondary	Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)	The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 >/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.	From randomization (Week 24) to Week 48
Secondary	Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 Greater Than [>] 6, Maintained for At Least 2 Consecutive Weeks)	The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >6 for at least 2 consecutive weeks post-randomization between weeks 24 and 48.	From randomization (Week 24) to Week 48
Secondary	Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab	The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score (Week 48 score minus Week 24 score) indicates improvement.	Week 24 (randomization) and Week 48
Secondary	Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization	The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score indicates improvement.	At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60)