chronic spontaneous urticaria MedDRA version: 18.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Xolair
Product Name: Xolair
Product Code: IGE031
Pharmaceutical Form: Solution for injection
INN or Proposed INN: OMALIZUMAB
CAS Number: 242138-07-4
Concentration unit: mg/ml milligram(s)/
Sponsors
NOVARTIS PHARMA SAS
Eligibility
Sex/Gender
All
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the proportion of patients achieving disease control (urticaria control test [UCT] score of greater than or equal to 12) at Week 12 in adult patients with CSU with inadequate response to H1 antihistamine treatment and treated by omalizumab 300 mg S.C. every 4 weeks;Secondary Objective: • To assess the extent to which omalizumab 300 mg S.C. controls CSU after 12 weeks of treatment using the UCT score, with or without the presence of angioedema. • To assess the effect of omalizumab 300 mg S.C. on QoL after 12 weeks of treatment using the chronic urticaria quality of life (CU-QoL) questionnaire; the angioedema quality of life (AE-QoL) questionnaire and the dermatology life quality index (DLQI). • To assess the effect of omalizumab 300 mg S.C. on CSU disease activity after 12 weeks of treatment using the urticaria activity score (UAS7). • To assess the effect of omalizumab 300 mg S.C. on angioedema activity after 12 weeks of treatment using the angioedema activity score (AAS). ;Primary end point(s): To evaluate the proportion of patients achieving disease control (urticaria control test [UCT] score of greater than or equal to 12) ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To evaluate the UCT score changes, with or without the presence of angioedema. • To evaluate the change from baseline of chronic urticaria quality of life (CU-QoL) questionnaire; the angioedema quality of life (AE-QoL) questionnaire and the dermatology life quality index (DLQI). • To evaluate the change from baseline of urticaria activity score (UAS7). • To evaluate the change from baseline of the angioedema activity score (AAS). ;Timepoint(s) of evaluation of this end point: Week 12 and over time | — |
Countries
France
Contacts
Public ContactInformation&Communication Médicales
NOVARTIS PHARMA SAS
Outcome results
None listed