A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

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

ClinicalTrials.gov Identifier: NCT03580356

Novartis Reference Number: CQGE031C2303

Last Update: Mar 16, 2021

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population will consist of approximately 1050 male and female subjects aged ≥ 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study.

This is a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Condition

Chronic Spontaneous Urticaria

Phase

Phase 3

Overall status

Recruiting

Enrollment count

1050 participants

Start date

Oct 20, 2018

Completion date

Jun 16, 2022

Gender

All

Age(s)

12 Years and older (Child, Adult, Older Adult)

Interventions

Biological

Ligelizumab

Liquid in vial

Biological

Omalizumab

Lyophilized powder for solution in vial

Other

Placebo

Liquid in vial

Eligibility Criteria

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study. The subject's', parent'ssubject'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. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Male and female subjects ≥ 12 years of age at the time of screening.
CSU diagnosis for ≥ 6 months.
Diagnosis of CSU refractory to H1-AH at 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-AH
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-AH at only 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.

Key Exclusion Criteria:

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-, cholinergic- or 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 or omalizumab.
Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.