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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

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

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

NCT ID

NCT04984876

First Posted

July 29, 2021

Last Updated

October 23, 2023

Sponsor

Novartis Pharmaceuticals

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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

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

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

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

ZIP/Postal Code

35128

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Roma

State/Province

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.

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

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

Allergy, Peanut

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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