Phase 4
Completed N=205
A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
Source: ClinicalTrials.gov NCT02392624 ↗Enrolled (actual)
205
Serious AEs
2.4%
Results posted
Mar 2018
Primary outcomePrimary: 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) — 21.0; 60.4 percentage of participants — p=<0.0001
◆ Published Evidence
Established
21citations · ~3 / year
Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU).
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.
Linked Publications
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Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
21.0; 60.4 | <0.0001 sig |
| SECONDARY Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks) |
NA; 12.0 | <0.0001 sig |
| 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) |
32.1; 64.2 | 0.0004 sig |
| SECONDARY Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab |
0.69; 1.77 | <0.0001 sig |
| 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 |
30.51; -29.48 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02392624) and the linked publication. 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. Informational only — not medical advice.