Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment (SUNRISE)

Novartis

Status and phase: Completed; Phase 4

Conditions: CHRONIC SPONTANEOUS URTICARIA

Treatments: Drug: OMALIZUMAB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02550106

CIGE025EFR02

Details and patient eligibility

About

Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.

Enrollment: 136 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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136 participants in 1 patient group

OMALIZUMAB

Experimental group

Description:

sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Treatment:

Drug: OMALIZUMAB