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



Status:Recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:2/2/2019
Start Date:October 17, 2018
End Date:April 30, 2021
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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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

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.

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.


Key Inclusion Criteria:

- 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. 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-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 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.
We found this trial at
21
sites
Ypsilanti, Michigan 48197
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Asheville, North Carolina 28803
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Bangor, Maine 04401
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Cincinnati, Ohio 45229
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Colorado Springs, Colorado 80907
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Dallas, Texas 75216
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Denver, Colorado 80262
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Evansville, Indiana 47713
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Gilbert, Arizona 85234
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Gilbert, AZ
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Innsbruck,
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Litchfield Park, Arizona 85340
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Little Rock, Arkansas 72204
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Little Rock, AR
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Long Beach, California 90813
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Long Beach, CA
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Marietta, Georgia 30060
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Marietta, GA
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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Pflugerville, Texas 78660
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Pflugerville, TX
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San Antonio, Texas 78207
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South Burlington, Vermont 05403
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Tallahassee, Florida 32308
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Waldorf, Maryland 20602
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Waldorf, MD
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