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A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines

PHRR220211-004314

CQGE031E12301

2021-CT0648

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines

This is a Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 24 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Start Date Duration in Months Target Completion Date Actual Completion Date
2022-02-22 34 2024-12-22 0000-00-00

Pending

Awaiting EC approval and executed Clinical Trial Agreement

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR 3000006283930
Institution Region
Novartis Healthcare Philippines, Inc. NCR
Name E-Mail Institution and Institution Address
Anna Liza Calingasin Anna_liza.calingasin@novartis.com Novartis Healthcare Philippines, Inc. 5/F Ayala North Exchange Tower 1 Salcedo corner Amorsolo Streets Legaspi Village, Makati City 1229 Philippines
Name E-Mail Institution and Institution Address
Bimba HV bimba.hv@novartis.com Novartis Healthcare Philippines, Inc. 5/F Ayala North Exchange Tower 1 Salcedo corner Amorsolo Streets Legaspi Village, Makati City 1229 Philippines
Name Expertise Affiliation
Clarisse Garcia Mendoza Immunology De La Salle Health Sciences Institute
Michelle Joy De Vera, MD Immunology The Medical City
Project Location Institutional Ethics Review Board
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
The Medical City The Medical City - Institutional Review Board

Chronic Inducible Urticaria (CINDU)

The primary objective of this study is to demonstrate superiority of ligelizumab versus placebo with regards to the change from baseline in response to standardized provocation test at week 12 for each CINDU subtype. For each subtype of CINDU, the primary clinical question of interest is what the treatment effect of ligelizumab treatment versus placebo on the primary endpoint in participants with H1-AH as background medication is, or lack of efficacy, assuming that participants had never discontinued treatment due to other reasons or missed any treatment prior to Week 12 due to other non-human controlled emergency situations like COVID-19.

Unspecified

Pending

  • Philippines

Clinical Trial

CQGE031E12301

20211020102118

2022-01-28

0000-00-00

5

Unspecified

Unspecified

0000-00-00

  • History of hypersensitivity to any of the study drugs or its components or to drugs of similar classes (i.e. to murine, chimeric or human antibodies) or to the provocation test or items used in provocation tests
  • Participants who have concomitant CSU at screening
  • Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study
  • Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
  • Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
  • Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
  • Prior exposure to ligelizumab, omalizumab or other anti-IgE therapies.

Interventional

QGE031

Unspecified

None

Randomized

Double Blind

Unspecified

Single

The primary objective of this study is to demonstrate superiority of ligelizumab versus placebo with regards to the change from baseline in response to standardized provocation test at week 12 for each CINDU subtype. For each subtype of CINDU, the primary clinical question of interest is what the treatment effect of ligelizumab treatment versus placebo on the primary endpoint in participants with H1-AH as background medication is, or lack of efficacy, assuming that participants had never discontinued treatment due to other reasons or missed any treatment prior to Week 12 due to other non-human controlled emergency situations like COVID-19.

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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