Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

December 9, 2020 updated by: Novartis Pharmaceuticals

A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
382

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Novartis Investigative Site
      • Sydney, New South Wales, Australia, 2010
        • Novartis Investigative Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1V 4W2
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M4V 1R2
        • Novartis Investigative Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
    • Bayern
      • Muenchen, Bayern, Germany, 80802
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 11527
        • Novartis Investigative Site
      • Haidari Athens, Greece, 12462
        • Novartis Investigative Site
    • GR
      • Athens, GR, Greece, 115 27
        • Novartis Investigative Site
  • Japan
    • Hiroshima
      • Hiroshima city, Hiroshima, Japan, 734-8551
        • Novartis Investigative Site
    • Hokkaido
      • Obihiro-city, Hokkaido, Japan, 080-0013
        • Novartis Investigative Site
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama-city, Kanagawa, Japan, 221-0825
        • Novartis Investigative Site
    • Kumamoto
      • Kamimashi-gun, Kumamoto, Japan, 861-3101
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 602-8566
        • Novartis Investigative Site
    • Osaka
      • Sakai, Osaka, Japan, 593-8324
        • Novartis Investigative Site
    • Saitama
      • Saitama-city, Saitama, Japan, 330-0854
        • Novartis Investigative Site
    • Tokyo
      • Machida-city, Tokyo, Japan, 194-0013
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 143-0023
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 141 8625
        • Novartis Investigative Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454092
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115478
        • Novartis Investigative Site
      • Moscow, Russian Federation, 107076
        • Novartis Investigative Site
      • Smolensk, Russian Federation, 214019
        • Novartis Investigative Site
      • St Petersburg, Russian Federation, 194223
        • Novartis Investigative Site
      • St.-Petersburg, Russian Federation, 195112
        • Novartis Investigative Site
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Russian Federation, 420012
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spain, 14004
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29009
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41009
        • Novartis Investigative Site
    • Barcelona
      • Sant Joan Despi, Barcelona, Spain, 08970
        • Novartis Investigative Site
    • Cataluna
      • Barcelona, Cataluna, Spain, 08003
        • Novartis Investigative Site
      • Barcelona, Cataluna, Spain, 08035
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46015
        • Novartis Investigative Site
    • Galicia
      • La Coruna, Galicia, Spain, 15006
        • Novartis Investigative Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Novartis Investigative Site
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 407
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Tao-Yuan, Taiwan, 333
        • Novartis Investigative Site
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Novartis Investigative Site
      • London, United Kingdom, SE1 9RT
        • Novartis Investigative Site
    • Somerset
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Novartis Investigative Site
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Novartis Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novartis Investigative Site
    • California
      • Huntington Beach, California, United States, 92647
        • Novartis Investigative Site
      • Mission Viejo, California, United States, 92691
        • Novartis Investigative Site
    • Florida
      • Sarasota, Florida, United States, 34233
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40291
        • Novartis Investigative Site
      • Owensboro, Kentucky, United States, 42301
        • Novartis Investigative Site
    • Maryland
      • Waldorf, Maryland, United States, 20602
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Novartis Investigative Site
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Novartis Investigative Site
    • New York
      • Bronx, New York, United States, 10461
        • Novartis Investigative Site
      • Forest Hills, New York, United States, 11375
        • Novartis Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Novartis Investigative Site
      • Toledo, Ohio, United States, 43617
        • Novartis Investigative Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novartis Investigative Site
      • Fort Worth, Texas, United States, 76132
        • Novartis Investigative Site
      • Katy, Texas, United States, 77450
        • Novartis Investigative Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Novartis Investigative Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion 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

Exclusion Criteria:

  • Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
  • Evidence of parasitic infection
  • Any other skin disease with chronic itching
  • Previous treatment with omalizumab or QGE031
  • Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
  • History of anaphylaxis
  • History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
  • History of hypersensitivity to any of the study drugs or its components of similar chemical classes
  • Pregnant or nursing (lactating) women

Other protocol defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QGE031 24 mg s.c. q4w
ligelizumab 24 mg injection subcutaneous every 4 weeks
Biological: QGE031
Experimental: QGE031 72 mg s.c. q4w
ligelizumab 72 mg injection subcutaneous every 4 weeks
Biological: QGE031
Experimental: QGE031 240 mg s.c. q4w
ligelizumab 240 mg injection subcutaneous every 4 weeks
Biological: QGE031
Active Comparator: Omalizumab 300 mg s.c. q4w
omalizumab 300 mg injection subcutaneous every 4 weeks
Biological: Omalizumab
Placebo Comparator: Placebo s.c. q4w
placebo injection subcutaneous every 4 weeks
Other: Placebo
Experimental: QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
Biological: QGE031

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Complete Hives Response (HSS7=0)
Time Frame: Week 12

The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks).

Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21.

Hives Severity Score scale:

0 - None

  1. - Mild (1-6 hives/12 hours)
  2. - Moderate (7-12 hives/12 hours)
  3. - Severe (>12 hives/12 hours)

To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days
Time Frame: Week 12

Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Complete hives response defined as HSS7 = 0.

Hives Severity Score scale:

0 - None

  1. - Mild (1-6 hives/12 hours)
  2. - Moderate (7-12 hives/12 hours)
  3. - Severe (>12 hives/12 hours)
Week 12
Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days
Time Frame: Week 12

Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Hives Severity Score scale:

0 - None

  1. - Mild (1-6 hives/12 hours)
  2. - Moderate (7-12 hives/12 hours)
  3. - Severe (>12 hives/12 hours)
Week 12
HSS7=0 Response: at Week 20 Measured Over 7 Days
Time Frame: Week 20

Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Complete hives response defined as HSS7 = 0.

Hives Severity Score scale:

0 - None

  1. - Mild (1-6 hives/12 hours)
  2. - Moderate (7-12 hives/12 hours)
  3. - Severe (>12 hives/12 hours)
Week 20
Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days
Time Frame: Week 20

Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Hives Severity Score scale:

0 - None

  1. - Mild (1-6 hives/12 hours)
  2. - Moderate (7-12 hives/12 hours)
  3. - Severe (>12 hives/12 hours)
Week 20
Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days
Time Frame: Week 12

Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Itch Severity Score scale:

0 - None

  1. - Mild (minimal awareness, easily tolerated)
  2. - Moderate (definite awareness, bothersome but tolerable)
  3. - Severe (difficult to tolerate)
Week 12
Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days
Time Frame: Week 20

Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Itch Severity Score scale:

0 - None

  1. - Mild (minimal awareness, easily tolerated)
  2. - Moderate (definite awareness, bothersome but tolerable)
  3. - Severe (difficult to tolerate)
Week 20
Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days
Time Frame: Week 12
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Week 12
Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days
Time Frame: Week 20
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Week 20
Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days
Time Frame: Week 12

UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.

Complete urticaria activity response is defined as UAS7 = 0.
Week 12
UAS7=0 Response: at Week 20 Measured Over 7 Days
Time Frame: Week 20

UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.

Complete urticaria activity response is defined as UAS7 = 0.
Week 20
Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days
Time Frame: Week 12

Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Complete itch response defined as ISS7 = 0.

Itch Severity Score scale:

0 - None

  1. - Mild (minimal awareness, easily tolerated)
  2. - Moderate (definite awareness, bothersome but tolerable)
  3. - Severe (difficult to tolerate)
Week 12
ISS7=0 Response: at Week 20 Measured Over 7 Days
Time Frame: Week 20

Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Complete itch response defined as ISS7 = 0.

Itch Severity Score scale:

0 - None

  1. - Mild (minimal awareness, easily tolerated)
  2. - Moderate (definite awareness, bothersome but tolerable)
  3. - Severe (difficult to tolerate)
Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQGE031C2201
  • 2014-005559-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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