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Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy

Primary Purpose

Allergy, Peanut

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ligelizumab
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy, Peanut focused on measuring Food allergy, Peanut allergy, Oral food challenge, IgE, ligelizumab

Eligibility Criteria

6 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female participants who are ≥ 6 and ≤ 55 years of age at the time of signing informed consent/assent.
  • Documented medical history of allergy to peanuts or peanut-containing foods.
  • Positive peanut-specific immunoglobulin E (peanut sIgE), ≥ 0.35 kUA/L at Screening visit 1 (Screening 1).
  • Positive skin prick test (SPT) for peanut allergen at Screening 1 defined as an average diameter (Longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to saline control.
  • A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2 DBPCFC) defined as the occurrence of dose-limiting symptoms at a single dose ≤ 100 mg of peanut protein. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
  • Participants must weigh ≥ 20 kg at Screening 1.

Exclusion Criteria:

  • Total IgE >2000 IU/mL at Screening 1.
  • History of severe or life-threatening hypersensitivity event needing an ICU admission or intubation within 60 days prior to baseline DBPCFC (Screening visit 2).
  • Participants with uncontrolled asthma (according to GINA guidelines, GINA 2020) who meet any of the following criteria:
  • FEV1 <80% of subject's predicted normal value at Screening visit 1
  • One hospitalization for asthma within 12 months prior to Screening visit 1

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ligelizumab 240 mg

ligelizumab 120 mg

Placebo 8 weeks and ligelizumab 120 mg

Placebo 16 weeks and ligelizumab 120 mg/240 mg

Placebo 8 weeks and ligelizumab 240 mg

Arm Description

ligelizumab 240 mg subcutaneous injection for 52 weeks

ligelizumab 120 mg subcutaneous injection for 52 weeks

Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks

Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks

Outcomes

Primary Outcome Measures

Proportion of participants who can tolerate a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Responder status is defined as tolerating a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12

Secondary Outcome Measures

Proportion of participants who can tolerate a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Responder status is defined as tolerating a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12
Proportion of participants who can tolerate a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Responder status is defined as tolerating a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12
Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000 mg at Week 12
Maximum severity of symptoms will be assessed during the DBPCFC conducted at Week 12. Symptom severity will be categorized as 4 levels: None, Mild, Moderate, Severe
Proportion of participants who can tolerate a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 52
Responder status is defined as tolerating a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during DBPCFC conducted at Week 52
Change in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 52 compared to Week 12
Change in MTD of peanut protein without dose-limiting symptoms at Week 52 compared to Week 12. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator.
Change from baseline in peanut-specific IgE at Week 12, Week 16 and Week 52
Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE)
Change from baseline in peanut-specific IgG4 at Week 12, Week 16 and 52
Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4)
Change from baseline in SPT mean wheal diameters at Week 16, Week 56 and Week 68
Change from baseline (screening) in skin prick test (SPT) mean wheal diameters.
Change from baseline in total and domain scores in the FAQLQ by age and responder (subject and/or caregiver)
The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by Food Allergy Quality of Life Questionnaire (FAQLQ)
Change from baseline in total and domain scores in the FAIM by age and responder (subject and/or caregiver)
The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by Food Allergy Independent Measure (FAIM).
Change from baseline in total and domain scores in the SF-36v2 by age and responder (subject and/or caregiver)
The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by a Medical Outcomes Study 36-Item Short Form Version 2 (SF-36v2).

Full Information

First Posted
July 29, 2021
Last Updated
October 23, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04984876
Brief Title
Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
Official Title
A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
May 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) subcutaneous injection every 4 weeks (SCq4w) in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.
Detailed Description
This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) subcutaneous injection every 4 weeks (SCq4w) in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy. Participants will be randomized to ligelizumab 240 mg, ligelizumab 120 mg, or placebo (5 treatment arms, randomization ratio of 2:2:2:2:1) for the double-blind placebo-controlled treatment period (up to Week 12). Participants initially assigned to the 8-week placebo arms will receive the first dose of blinded ligelizumab treatment at the Week 8 visit. Participants initially assigned to the 16-week placebo arm will receive the last dose of placebo before the double blind placebo controlled food challenge (DBPCFC) at week 12 and the first dose of blinded ligelizumab treatment at the Week 16 visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Peanut
Keywords
Food allergy, Peanut allergy, Oral food challenge, IgE, ligelizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
486 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ligelizumab 240 mg
Arm Type
Experimental
Arm Description
ligelizumab 240 mg subcutaneous injection for 52 weeks
Arm Title
ligelizumab 120 mg
Arm Type
Experimental
Arm Description
ligelizumab 120 mg subcutaneous injection for 52 weeks
Arm Title
Placebo 8 weeks and ligelizumab 120 mg
Arm Type
Experimental
Arm Description
Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks
Arm Title
Placebo 16 weeks and ligelizumab 120 mg/240 mg
Arm Type
Experimental
Arm Description
Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
Arm Title
Placebo 8 weeks and ligelizumab 240 mg
Arm Type
Experimental
Arm Description
Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks
Intervention Type
Drug
Intervention Name(s)
ligelizumab
Intervention Description
Subcutaneous injection once every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection once every 4 weeks
Primary Outcome Measure Information:
Title
Proportion of participants who can tolerate a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Description
Responder status is defined as tolerating a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of participants who can tolerate a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Description
Responder status is defined as tolerating a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12
Time Frame
Week 12
Title
Proportion of participants who can tolerate a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Description
Responder status is defined as tolerating a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12
Time Frame
Week 12
Title
Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000 mg at Week 12
Description
Maximum severity of symptoms will be assessed during the DBPCFC conducted at Week 12. Symptom severity will be categorized as 4 levels: None, Mild, Moderate, Severe
Time Frame
Week 12
Title
Proportion of participants who can tolerate a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 52
Description
Responder status is defined as tolerating a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during DBPCFC conducted at Week 52
Time Frame
Week 52
Title
Change in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 52 compared to Week 12
Description
Change in MTD of peanut protein without dose-limiting symptoms at Week 52 compared to Week 12. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator.
Time Frame
Week 12 and Week 52
Title
Change from baseline in peanut-specific IgE at Week 12, Week 16 and Week 52
Description
Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE)
Time Frame
Baseline, Week 12, 16 and 52
Title
Change from baseline in peanut-specific IgG4 at Week 12, Week 16 and 52
Description
Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4)
Time Frame
Baseline, Week 12, 16 and 52
Title
Change from baseline in SPT mean wheal diameters at Week 16, Week 56 and Week 68
Description
Change from baseline (screening) in skin prick test (SPT) mean wheal diameters.
Time Frame
Baseline, Week 16, 56 and 68
Title
Change from baseline in total and domain scores in the FAQLQ by age and responder (subject and/or caregiver)
Description
The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by Food Allergy Quality of Life Questionnaire (FAQLQ)
Time Frame
Baseline, Week 12 and 56
Title
Change from baseline in total and domain scores in the FAIM by age and responder (subject and/or caregiver)
Description
The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by Food Allergy Independent Measure (FAIM).
Time Frame
Baseline, Week 12 and 56
Title
Change from baseline in total and domain scores in the SF-36v2 by age and responder (subject and/or caregiver)
Description
The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by a Medical Outcomes Study 36-Item Short Form Version 2 (SF-36v2).
Time Frame
Baseline, Week 12 and 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants who are ≥ 6 and ≤ 55 years of age at the time of signing informed consent/assent. Documented medical history of allergy to peanuts or peanut-containing foods. Positive peanut-specific immunoglobulin E (peanut sIgE), ≥ 0.35 kUA/L at Screening visit 1 (Screening 1). Positive skin prick test (SPT) for peanut allergen at Screening 1 defined as an average diameter (Longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to saline control. A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2 DBPCFC) defined as the occurrence of dose-limiting symptoms at a single dose ≤ 100 mg of peanut protein. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria. Participants must weigh ≥ 20 kg at Screening 1. Exclusion Criteria: Total IgE >2000 IU/mL at Screening 1. History of severe or life-threatening hypersensitivity event needing an ICU admission or intubation within 60 days prior to baseline DBPCFC (Screening visit 2). Participants with uncontrolled asthma (according to GINA guidelines, GINA 2020) who meet any of the following criteria: FEV1 <80% of subject's predicted normal value at Screening visit 1 One hospitalization for asthma within 12 months prior to Screening visit 1 Other protocol-defined inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0922
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-9500
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5066
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Angers Cedex 1
ZIP/Postal Code
49033
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00146
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Sagamihara-city
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy

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