A Phase III study of safety and efficacy of ligelizumab in the treatment of CSU in

JRCT ID: jRCT2080224633

Registered date:11/04/2019

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Chronic Spontaneous Urticaria
• Date of first enrollment: 13/04/2019
• Target sample size: 66
• Countries of recruitment: Japan
• 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

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

Secondary Outcome

efficacy
*Absolute change from baseline of UAS7, HSS7 and ISS7 by visit up to end of study
*Proportion of subjects with UAS7 = 0, HSS7 = 0, and ISS7 = 0 response by visit up to the end of study
*Absolute change from baseline of DLQI by visit up to end of study
*Proportion of subjects with DLQI = 0/1 by visit up to end of study

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

*Diagnosis of chronic spontaneous urticaria for at least 6 months
*Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Exclude criteria

*History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes
*Clearly defined, predominant trigger of their chronic inducible urticaria
*Evidence of parasitic infection
*Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results
*Prior exposure to ligelizumab
*Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.

Other protocol defined inclusion/exclusion may apply

Related Information

• Secondary ID(s): NCT03907878,JapicCTI-194705