Study of efficacy and safety of ligelizumab in chronic spontaneous urticaria patients who completed a previous study with ligelizumab

JRCT ID: jRCT2080225155

Registered date:07/04/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Chronic Spontaneous Urticaria
• Date of first enrollment: 08/04/2020
• Target sample size: 100
• Countries of recruitment: Japan,Asia except Japan,North America,South America,Europe,Oceania,Africa
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc :
INN of investigational material : Ligelizumab
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational material : Ligelizumab q4w

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome

efficacy
* The proportion of subjects with well-controlled disease (UAS7 <= 6) at Week 12

Secondary Outcome

safety
efficacy
other
* The proportion of subjects with completely controlled disease (UAS7 = 0) at Week 12
* Absolute change from extension study baseline in the UAS7 and its components (ISS7 and HSS7) at Week 12
* Cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12
* Percentage of subjects achieving DLQI = 0-1 at Week 12
* The proportion of subjects with well-controlled disease (UAS7 <= 6), 12 weeks after starting self-administration
* To assess the safety and tolerability of ligelizumab in all subjects. Occurrence of treatment emergent adverse events during the study
* To assess the safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer. Occurrence of treatment emergent adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

*Written informed consent
*Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
*Male and female, adult and adolescent subjects >=12 years of age
*Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule

Exclude criteria

*Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment
*Use of omalizumab within 16 weeks of Screening
*History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes
*New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.
*Diseases with possible symptoms of urticaria or angioedema
*Subjects with evidence of helminthic parasitic infection
*Documented history of anaphylaxis
*Pregnant or nursing (lactating) women

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT04210843,JapicCTI-205251