A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines
- Conditions
- Chronic sponataneous UrticariaRash10002426
- Registration Number
- NL-OMON52375
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 32
Signed informed consent must be obtained prior to participation in the study.
The subject's, parent's or legal guardian's signed written informed consent and
child's assent, if appropriate, must be obtained before any assessment is
performed., * Male and female subjects >= 12 years of age at the time of
screening.
* CSU diagnosis for >= 6 months (defined as onset of CSU with supporting
documentation).
* Diagnosis of CSU refractory to H1-AH at locally label approved doses at the
time of randomization, as defined by all of the following:
* The presence of itch and hives for >= 6 consecutive weeks at any time prior to
Visit 1 (Day - 28 to Day -14) despite current use of non-sedating
H1-antihistamine
* UAS7 score (range 0-42) >= 16 and HSS7 (range 0-21) >= 8 during the 7 days
prior to randomization (Visit 110, Day 1)
* Subjects must be on H1-antihistamine at only locally label approved doses for
treatment of CSU starting at Visit 1 (Day -28 to Day -14)
* Willing and able to complete a daily symptom eDiary for the duration of the
study and adhere to the study visit schedules.
* Other protocol-defined inclusion criteria may apply
History of hypersensitivity to any of the study drugs or their excipients or to
drugs of similar chemical classes (i.e. to murine, chimeric or human
antibodies).
* Subjects having a clearly defined cause of their chronic urticaria, other
than CSU. This includes, but is not limited to, the following: symptomatic
dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed
pressure-, aquagenic-, cholinergicor contact-urticaria.
* Diseases, other than chronic urticaria, with urticarial or angioedema
symptoms such as urticarial vasculitis, erythema multiforme, cutaneous
mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg,
due to C1 inhibitor deficiency).
* Subjects with evidence of helminthic parasitic infection as evidenced by
stools being positive for a pathogenic organism according to local guidelines.
All subjects will be screened at Visit 1. If stool testing is positive for
pathogenic organism, the subject will not be randomized and will not be allowed
to rescreen.
* Any other skin disease associated with chronic itching that might influence
in the investigators opinion the study evaluations and results (e.g. atopic
dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus,
etc.).
* Prior exposure to ligelizumab, omalizumab and other IgE therapies.
* Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1-AH used as
background medication at greater than local label approved doses after Visit 1.
* Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the study is to demonstrate that ligelizumab (72 mg<br /><br>q4w and/or 120 mg q4w) is superior to placebo and superior to omalizumab 300 mg<br /><br>q4w in change from baseline in UAS7 at Week 12</p><br>
- Secondary Outcome Measures
Name Time Method <p>Objective 1: To demonstrate that a greater proportion of subjects achieve UAS7<br /><br>= 0 at Week 12 who are treated with ligelizumab 72 mg q4w and/or 120 mg q4w<br /><br>compared to placebotreated subjects and compared with omalizumab 300 mg q4w<br /><br>treated subjects.<br /><br>Objective 2: To demonstrate the superiority of ligelizumab 72 mg q4w and/or 120<br /><br>mg q4w treated subjects with respect to a reduction from baseline in the weekly<br /><br>itch severity score at Week 12 compared to placebo-treated subjects and<br /><br>omalizumab 300 mg q4w treated subjects.</p><br>