Study of quality of life in chronic Spontaneous Urticaria patients and treated by omalizumab (Xolair®)

Phase 1

• Conditions: chronic spontaneous urticaria; MedDRA version: 18.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-005424-97-FR
• Lead Sponsor: OVARTIS PHARMA SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-24
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1.Male or female patients aged between 18 and 75 years.
2.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).
3.Patients must document current use of an H1 antihistamine for CSU on the day of the initial visit and Day 1.
4.Willing and able to complete a daily symptom diary (paper) for the duration of the study.
5.Willing to give written informed consent, adhere to the visit schedules and meet clinical requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

1.Treatment with an investigational agent within 30 days before enrollment.
2.Body weight less than 40 kg.
3.Clearly defined underlying etiology for chronic urticaria other than CSU (main manifestation being physical urticaria). This includes the following urticaria types: acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact urticaria, or skin disease that includes urticarial plaques (other than CSU) such as bullous pemphigoid, dermatitis herpetiformis.
4.The following diseases which may have symptoms of urticaria or angioedema: urticarial vasculitis, urticaria pigmentosa, erythema multiform, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, generalized cancer.
5.Evidence of parasitic infection defined as having the following three items:
•Risk factors for parasitic disease (living in an endemic area, chronic gastrointestinal symptoms, travel within the last 6 months to an endemic area and/or chronic immunosuppression).
AND
•An absolute eosinophil count more than twice the upper limit of normal (ULN).
AND
•Evidence of parasitic colonization or infection in stool evaluation for ova and parasites; note that stool ova and parasite evaluation will only be conducted in patients with both risk factors and an eosinophil count more than twice the ULN.
6.Patients with current malignancy, history of malignancy, or currently under work up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
7.Concomitant use of cyclosporine or any other immunosuppressive agent.
8.Hypersensitivity to omalizumab or any component of the formulation.
9.History of anaphylactic shock.
10.Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions that could compromise the safety of the patients.
11.Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions. Any items that are cause for uncertainty must be reviewed with the attending physician.
12.Inability or unwillingness to comply with the visits and follow-up procedures.
13.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment.
14.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.
15.Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7
16.Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.
17.Any H2 antihistamine use within 7 days prior to Day -7.
18.Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7.
19.Evidence of current drug or alcohol abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified