Phase 4
N=136
Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment
CHRONIC SPONTANEOUS URTICARIA
Bottom Line
View on ClinicalTrials.gov: NCT02550106 ↗Enrolled (actual)
136
Serious AEs
6.6%
Results posted
Feb 2020
Primary outcome: Primary: Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 — 75.0 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- OMALIZUMAB (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 |
75.0 | — |
| SECONDARY Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema |
69.6; 63.8 | — |
| SECONDARY CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema |
29.7; 29.2; 6.6; 6.5 | — |
| SECONDARY Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 |
3.0; 3.6; 13.1; 12.9 | — |
| SECONDARY Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema |
14.2; 13.4 | — |
| SECONDARY Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema |
14.4; 13.3 | — |
| SECONDARY Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema |
14.5; 13.4 | — |
| SECONDARY Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema |
13.5; 12.0 | — |
| SECONDARY The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire |
68.9; 62.4; 32.5; 33.3 | — |
| SECONDARY The Angioedema Quality of Life (AE-QoL) |
57.88; 16.40 | — |
| SECONDARY The Dermatology Life Quality Index (DLQI) |
14.2; 13.2; 2.4; 2.7 | — |
| SECONDARY Angioedema Activity Using the Angioedema Activity Score (AAS) |
32.7; 3.7 | — |
Summary
Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged between 18 and 75 years.
- Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following:
- The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period.
- Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) < 8 prior to enrollment (Day 1)
- Current use of an H1 antihistamine for CSU on the day of the initial visit and Day
- Informed consent
Exclusion Criteria
- Treatment with an investigational agent within 30 days before enrollment.
- Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
- Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7
- Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.
- Any H2 antihistamine use within 7 days prior to Day -7.
- Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7.
- Concomitant use of cyclosporine or any other immunosuppressive agent.
- Hypersensitivity to omalizumab or any component of the formulation.
- History of anaphylactic shock.
Data sourced from ClinicalTrials.gov (NCT02550106). 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.