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Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04210843
Recruitment Status : Active, not recruiting
First Posted : December 26, 2019
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 17, 2019
First Posted Date  ICMJE December 26, 2019
Last Update Posted Date July 28, 2022
Actual Study Start Date  ICMJE April 8, 2020
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2019)
The proportion of subjects with well-controlled disease (UAS7 ≤ 6) at Week 12 [ Time Frame: Week 12 ]
The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). The HSS, defined by number of hives (wheals), will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0 - 21. The severity of the itch will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0-21 (maximum itch). The UAS7 is the sum of the HSS7 score and the ISS7 score. The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2019)
  • Complete control of chronic spontaneous urticaria (CSU) at Week 12 [ Time Frame: Week 12 ]
    Assessed as the proportion of subjects with completely controlled disease (UAS7 =0) at Week 12
  • A reduction from extension study baseline in the UAS7 at Week 12 [ Time Frame: Week 12 ]
    Assessed as absolute change from extension study baseline in the UAS7 at Week 12
  • A reduction from extension study baseline in the ISS7 at Week 12 [ Time Frame: Week 12 ]
    Assessed as absolute change from extension study baseline in the ISS7 (weekly itch severity score) at Week 12
  • A reduction from extension study baseline in the HSS7 at Week 12 [ Time Frame: Week 12 ]
    Assessed as absolute change from extension study baseline in the HSS7 (weekly hives severity score) at Week 12
  • Achieving an angioedema-free period at Week 12 [ Time Frame: Week 12 ]
    Assessed as cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12
  • Achieving Dermatology Life Quality Index (DLQI) = 0-1 at Week 12 [ Time Frame: Week 12 ]
    Assessed as percentage of subjects achieving DLQI = 0-1 at Week 12
  • Efficacy of ligelizumab in the treatment of CSU, 12 weeks after starting self-administration [ Time Frame: Week 12 ]
    Assessed as the proportion of subjects with well-controlled disease (UAS7 ≤ 6), 12 weeks after starting self-administration
  • Safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer [ Time Frame: from Week 24 to Week 104 ]
    Occurence of Adverse Events for patients who self-administer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Official Title  ICMJE A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
Brief Summary

The purpose of this extension study is to establish efficacy and safety of ligelizumab. This will be assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed.

This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Spontaneous Urticaria
Intervention  ICMJE Drug: Ligelizumab
liquid in vial 120 mg/mL Prefilled Syringe 120 mg/mL
Other Name: QGE031
Study Arms  ICMJE
  • Experimental: Ligelizumab Dose 1 and 3
    Liquid in vial 72 mg/mL followed by 120 mg/mL PFS
    Intervention: Drug: Ligelizumab
  • Experimental: Ligelizumab Dose 2 and 3
    Liquid in vial 120 mg/mL followed by 120 mg/mL PFS
    Intervention: Drug: Ligelizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 27, 2022)
1038
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2019)
800
Estimated Study Completion Date  ICMJE August 30, 2022
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion 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

Key Exclusion 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   Estonia,   France,   Germany,   Greece,   Guatemala,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Lebanon,   Malaysia,   Mexico,   Netherlands,   Oman,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Tunisia,   Turkey,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04210843
Other Study ID Numbers  ICMJE CQGE031C2302E1
2019-001792-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP