A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines

A Multi-center, Open-label Study to Investigate the Safety/Tolerability and Efficacy of Ligelizumab (QGE031) in the Treatment of Adult Japanese Patients With Chronic Spontaneous Urticaria (CSU) Inadequately Controlled With H1 Antihistamines

ClinicalTrials.gov Identifier: NCT03907878

Novartis Reference Number: CQGE031C1301

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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 evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses.

The study population will consist of approximately 65 male and female subjects aged ≥ 18 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-AH.

This is a Phase III multi-center, open-label, single arm study. There is a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.

Condition 
Chronic Spontaneous Urticaria
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
65 participants
Start date 
Apr 13, 2019
Completion date 
Feb 11, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
Ligelizumab
Liquid in vial

Eligibility Criteria

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Male and female subjects ≥ 18 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 Baseline (Visit 110, Day 1), 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 (at locally approved doses) during this time period
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to baseline (Visit 110, Day 1)
Subjects must be on H1-AH at only approved doses for treatment of CSU for starting at Visit 1 (Day -28 to Day -14)
Willing and able to complete a daily symptom electronic Diary (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 treatments or excipients or to drugs of similar chemical classes (i.e. to murine, chimeric, or human antibodies)

Subjects having a clearly defined, predominant trigger of their chronic urticaria (CU) (chronic inducible urticaria (CINDU)) including

- urticaria factitia (symptomatic dermographism), 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 (e.g., 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 enter treatment period and will not be allowed to rescreen
Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid (BP), dermatitis herpetiformis, senile pruritus, etc)
Prior exposure to ligelizumab
Any H2 antihistamine, Leukotriene Receptor Antagonist (LTRA) (montelukast or zafirlukast) or H1 antihistamines use at greater than approved dose after Visit 1

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

Japan
Novartis Investigative Site
Recruiting
Ichikawa, 272-0033
Chiba
Japan
Novartis Investigative Site
Recruiting
Obihiro, 080 0013
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Kobe-shi, 650-0017
Hyogo
Japan
Novartis Investigative Site
Recruiting
Nishinomiya-city, 663-8186
Hyogo
Japan
Novartis Investigative Site
Active, not recruiting
Yokohama, 221-0825
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 222-0033
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Neyagawa, 572-0838
Osaka
Japan
Novartis Investigative Site
Recruiting
Sakai, 593-8324
Osaka
Japan
Novartis Investigative Site
Recruiting
Itabashi-ku, 173-8610
Tokyo
Japan
Novartis Investigative Site
Recruiting
Machida-city, 194-0013
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hiroshima, 734-8551
-
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+81337978748
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]