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

NCT03907878 | Completed Phase 3 Results

• 1 other identifier: CQGE031C1301
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study was 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 consisted of 66 male and female subjects aged ≥ 18 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-AH. This was a Phase III multi-center, open-label, single arm study. There was a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.

Conditions

Chronic Spontaneous Urticaria

Keywords

CSU; chronic spontaneous urticaria; Japanese; QGE031; Anti-IgE; Ligelizumab; Japan

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months

  Participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) summary for entire study (64 weeks) An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.

  64 weeks

Secondary Outcomes (8)

• UAS7 Change From Baseline Over Time

  Baseline, Weeks 12, 24, 52, and 64

• HSS7 Change From Baseline Over Time

  Baseline, Weeks 12, 24, 52, and 64

• ISS7 Change From Baseline Over Time

  Baseline, Weeks 12, 24, 52, and 64

• Percentage of Participants Who Achieved the Complete UAS7 = 0 Response Over Time

  Weeks 12, 24, 52, and 64

• Percentage of Participants Who Achieved the Complete HSS7 = 0 Response Over Time

  Weeks 12, 24, 52, and 64

Study Arms (1)

Ligelizumab 120 mg per 1 mL qw4

EXPERIMENTAL

Subjects received one subcutaneous injection every 4 weeks at 13 visits during the treatment period

Biological: Ligelizumab

Interventions

Ligelizumab BIOLOGICAL

Liquid in vial

Also known as: QGE031

Ligelizumab 120 mg per 1 mL qw4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Novartis Investigative Site

Ichikawa, Chiba, 272-0033, Japan

Location

Novartis Investigative Site

Obihiro, Hokkaido, 080 0013, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Nishinomiya, Hyōgo, 663-8186, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 221-0825, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 222-0033, Japan

Location

Novartis Investigative Site

Neyagawa, Osaka, 572-0838, Japan

Location

Novartis Investigative Site

Sakai, Osaka, 593-8324, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Novartis Investigative Site

Machida, Tokyo, 194-0013, Japan

Location

Novartis Investigative Site

Hiroshima, 734-8551, Japan

Location

Related Links

• A Plain Language Trial Summary is Available at www.novctrd.com

MeSH Terms

Conditions

Chronic Urticaria

Interventions

ligelizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: April 13, 2019
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: March 6, 2025
• Results First Posted: March 8, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (11)