Phase 3
N=91
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
Chronic Spontaneous Urticaria · Angioedema
Bottom Line
View on ClinicalTrials.gov: NCT01723072 ↗Enrolled (actual)
91
Serious AEs
6.6%
Results posted
Sep 2020
Primary outcome: Primary: Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) — -25.5; -6.4; -32.1; -12.1 score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omalizumab (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) |
-25.5; -6.4; -32.1; -12.1; -31.4; -16.2 | — |
| SECONDARY Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation) |
5.2; 6.8; 14.6; 49.5; 5.8; 12.8 | — |
| SECONDARY Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes |
20; 7.8; 11.0; 7.2; 26.4; 8.3 | — |
| SECONDARY Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) |
-17.7; -5.0; -19.0; -9.0; -21.3; -16.9 | — |
| SECONDARY Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) |
146; 165; 54; 99; 19; 46 | — |
| SECONDARY Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) |
31; 76; 0; 94; 0; 24 | — |
| SECONDARY Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) |
92; 90; 28; 58; 8; 19 | — |
| SECONDARY Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) |
203; 264; 13; 25; 7; 25 | — |
| SECONDARY Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) |
28; 195; 3; 5; 0; 5 | — |
| SECONDARY Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) |
127; 172; 14; 5; 1; 3 | — |
| SECONDARY Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) |
-26.5; -10.3; -37.4; -20.4; -37.1; -28.8 | — |
| SECONDARY Rescue Medication During the Treatment Period |
25; 35; 19; 27; 12; 26 | — |
| SECONDARY Days of Rescue Medication During the Treatment Period |
507; 787; 403; 524; 92; 236 | — |
| SECONDARY Days of Rescue Medication During the Follow-up Period |
165; 118; 158; 85; 15; 19 | — |
| SECONDARY Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) |
-12.6; -3.0; -16.4; -4.4; -15.0; -7.2 | — |
| SECONDARY Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) |
-8.3; -2.4; -10.1; -3.9; -9.5; -5.1 | — |
Summary
This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistamine treatment
- Presence of itch an hives for more than 6 weeks
- UAS7 score of more than 14 (range 0-42)
- Patient has history of insufficient response to 4x of the approved dose of H1-antihistamines
- CSU diagnosis for more than 6 months
- Angioedema at least 4x in the last 6 months
Exclusion Criteria
- Patients with non urticaria associated angioedema
- History of hypersensitivity to omalizumab or the rescue medication or to drugs of similar chemical structure
- Evidence of parasitic infection
- Previous treatment with omalizumab within the last 6 months prior to screening
- History of anaphylactic shock
- Woman who are pregnant or breast feeding
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01723072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.