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

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ClinicalTrials.gov Identifier: NCT02477332
Recruitment Status : Completed
First Posted : June 22, 2015
Results First Posted : September 14, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Biological: QGE031 Biological: Omalizumab Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : July 15, 2015
Actual Primary Completion Date : November 2, 2016
Actual Study Completion Date : June 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab

Arm Intervention/treatment
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



Primary Outcome Measures :
  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

    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.



Secondary Outcome Measures :
  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

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

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

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

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

    1. - Mild (minimal awareness, easily tolerated)
    2. - Moderate (definite awareness, bothersome but tolerable)
    3. - 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

    1. - Mild (minimal awareness, easily tolerated)
    2. - Moderate (definite awareness, bothersome but tolerable)
    3. - 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

    1. - Mild (minimal awareness, easily tolerated)
    2. - Moderate (definite awareness, bothersome but tolerable)
    3. - 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

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477332


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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02477332     History of Changes
Other Study ID Numbers: CQGE031C2201
2014-005559-16 ( EudraCT Number )
First Posted: June 22, 2015    Key Record Dates
Results First Posted: September 14, 2018
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QGE031
ligelizumab
omalizumab
chronic
spontaneous
urticaria
adults
CSU

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents