Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
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| ClinicalTrials.gov Identifier: NCT04984876 |
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Recruitment Status :
Recruiting
First Posted : August 2, 2021
Last Update Posted : March 27, 2023
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Allergy, Peanut | Drug: ligelizumab Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 486 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | December 7, 2021 |
| Estimated Primary Completion Date : | January 28, 2025 |
| Estimated Study Completion Date : | May 21, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ligelizumab 240 mg
ligelizumab 240 mg subcutaneous injection for 52 weeks
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Drug: ligelizumab
Subcutaneous injection once every 4 weeks |
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Experimental: ligelizumab 120 mg
ligelizumab 120 mg subcutaneous injection for 52 weeks
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Drug: ligelizumab
Subcutaneous injection once every 4 weeks |
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Experimental: Placebo 8 weeks and ligelizumab 120 mg
Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks
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Drug: ligelizumab
Subcutaneous injection once every 4 weeks Drug: Placebo Subcutaneous injection once every 4 weeks |
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Experimental: Placebo 16 weeks and ligelizumab 120 mg/240 mg
Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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Drug: ligelizumab
Subcutaneous injection once every 4 weeks Drug: Placebo Subcutaneous injection once every 4 weeks |
|
Experimental: Placebo 8 weeks and ligelizumab 240 mg
Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks
|
Drug: ligelizumab
Subcutaneous injection once every 4 weeks Drug: Placebo Subcutaneous injection once every 4 weeks |
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 12 and Week 52 ]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 [ Time Frame: Baseline, Week 12, 16 and 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 [ Time Frame: Baseline, Week 12, 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 [ Time Frame: Baseline, Week 16, 56 and 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) [ Time Frame: Baseline, Week 12 and 56 ]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) [ Time Frame: Baseline, Week 12 and 56 ]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) [ Time Frame: Baseline, Week 12 and 56 ]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).
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| Ages Eligible for Study: | 6 Years to 55 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT04984876
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals | +41613241111 |
Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04984876 |
| Other Study ID Numbers: |
CQGE031G12301 |
| First Posted: | August 2, 2021 Key Record Dates |
| Last Update Posted: | March 27, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 ):
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Food allergy Peanut allergy Oral food challenge IgE ligelizumab |
Additional relevant MeSH terms:
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Hypersensitivity Peanut Hypersensitivity Immune System Diseases |
Nut and Peanut Hypersensitivity Food Hypersensitivity Hypersensitivity, Immediate |