Back to results

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

Primary Purpose

Chronic Spontaneous Urticaria

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Ligelizumab

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring CSU (chronic spontaneous urticaria), Japanese, QGE031, Anti-IgE, Ligelizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ligelizumab

Arm Description

Ligelizumab q4w

Outcomes

Primary Outcome Measures

Safety and tolerability for 12 months

Overall safety data assessed as treatment emergent adverse events during the study

Secondary Outcome Measures

UAS7 change from baseline over time

Assessed as absolute change from baseline of UAS7 by visit up to end of study. The Urticaria Activity Score (UAS) is the sum of Hive Severity Score (HSS) and Itch Severiry Score (ISS). The HSS has a scale of 0 (none) to 3 (intense/severe). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days. The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42.

HSS7 change from baseline over time

Assessed as absolute change from baseline of HSS7 by visit up to end of study.

ISS7 change from baseline over time

Assessed as absolute change from baseline of ISS7 by visit up to end of study.

Achievement of the complete UAS7 = 0 response over time

Assessed as proportion of subjects with UAS7 = 0 response by visit up to the end of study.

Achievement of the complete HSS7 = 0 response over time

Assessed as proportion of subjects with HSS7 = 0 response by visit up to the end of study.

Achievement of the complete ISS7 = 0 response over time

Assessed as proportion of subjects with ISS7 = 0 response by visit up to the end of study.

Profile of change from baseline in the Dermatology Life Quality Index (DLQI)

Assessed by absolute change from baseline of DLQI by visit up to end of study

Achievement of DLQI = 0/1 by visit up to end of study

Assessed as proportion of subjects with DLQI = 0/1 by visit up to end of study

Full Information

NCT ID

NCT03907878

First Posted

April 5, 2019

Last Updated

July 14, 2022

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03907878

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

April 13, 2019 (Actual)

Primary Completion Date

January 26, 2022 (Actual)

Study Completion Date

January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Spontaneous Urticaria

Keywords

CSU (chronic spontaneous urticaria), Japanese, QGE031, Anti-IgE, Ligelizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ligelizumab

Arm Type

Experimental

Arm Description

Ligelizumab q4w

Intervention Type

Biological

Intervention Name(s)

Ligelizumab

Intervention Description

Liquid in vial

Primary Outcome Measure Information:

Title

Safety and tolerability for 12 months

Description

Overall safety data assessed as treatment emergent adverse events during the study

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

UAS7 change from baseline over time

Description

Time Frame