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Completed

NCT Number: NCT02477332

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

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Key information

Conditions

Chronic Spontaneous Urticaria Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Chronic Urticaria Disease Attributes Graft vs Host Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Campbelltown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QGE031

Biological

Omalizumab

Biological

Placebo

Other

Primary outcomes

  1. 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

    • - Mild (1-6 hives/12 hours)
    • - Moderate (7-12 hives/12 hours)
    • - 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.

Secondary outcomes

  1. 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

    • - Mild (1-6 hives/12 hours)
    • - Moderate (7-12 hives/12 hours)
    • - Severe (>12 hives/12 hours)

  2. 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

    • - Mild (1-6 hives/12 hours)
    • - Moderate (7-12 hives/12 hours)
    • - Severe (>12 hives/12 hours)

  3. 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

    • - Mild (1-6 hives/12 hours)
    • - Moderate (7-12 hives/12 hours)
    • - Severe (>12 hives/12 hours)

  4. 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

    • - Mild (1-6 hives/12 hours)
    • - Moderate (7-12 hives/12 hours)
    • - Severe (>12 hives/12 hours)

  5. 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

    • - Mild (minimal awareness, easily tolerated)
    • - Moderate (definite awareness, bothersome but tolerable)
    • - Severe (difficult to tolerate)

  6. 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

    • - Mild (minimal awareness, easily tolerated)
    • - Moderate (definite awareness, bothersome but tolerable)
    • - Severe (difficult to tolerate)

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

    • - Mild (minimal awareness, easily tolerated)
    • - Moderate (definite awareness, bothersome but tolerable)
    • - Severe (difficult to tolerate)

  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

    • - Mild (minimal awareness, easily tolerated)
    • - Moderate (definite awareness, bothersome but tolerable)
    • - Severe (difficult to tolerate)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 22, 2015
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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