Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
550
Countries
5
Sites
19
Food allergy
To evaluate the long-term safety and tolerability of ligelizumab in participants with food allergy
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 11 Sep 2023 → 6 Mar 2025
- Decision date (initial)
- 2023-08-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy, Others
To evaluate the long-term safety and tolerability of ligelizumab in participants with food allergy
Secondary objectives 3
- To describe the long-term efficacy of ligelizumab as measured by the tolerance of an allergen food protein during an open-label OFC at scheduled timepoints.
- To assess the safety and tolerability of ligelizumab in all participants who are administered study treatment at home by self-administration or parent/caregiver
- To assess the long-term impact of ligelizumab on the health related quality of life (HRQoL) of patients with food allergy
Conditions and MedDRA coding
Food allergy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10016946 | Food allergy | 100000004870 |
| 20.0 | LLT | 10077084 | Allergic reaction to food | 10021428 |
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-005339-56 | 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, Etude multicentrique de 52 semaines, randomisée, en double aveugle, contrôlée par placebo évaluant l’efficacité et la sécurité d’emploi du ligélizumab (QGE031) dans la diminution de la sensibilité à l’arachide chez des patients allergiques à l’arachide, Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo de 52 semanas de duración para evaluar la eficacia clínica y la seguridad de ligelizumab (QGE031) en la disminución de la sensibilidad a los cacahuetes en pacientes con alergia al cacahuete., Studio multicentrico, randomizzato, in doppio cieco controllato verso placebo, di 52 settimane per valutare l’efficacia clinica e la sicurezza di ligelizumab (QGE031) nel ridurre la sensibilità alle arachidi in pazienti con allergia alle arachidi |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Signed informed consent form (ICF) and assent form (where applicable) obtained from the participant/legal representative before study participation. If a minor participant reaches the age of legal majority (as defined by local law), they must be re-consented at the next study visit
- Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy (e.g., Study CQGE031G12301). Please refer to the Section 4.1 for the timing of transition.
- Participants who are willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge)
- Participants who agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout this study
- Participants who are able to safely continue into the study as judged by the investigator
Exclusion criteria 6
- Development of a severe or life threatening episode of an allergic reaction that required intubation and/or ICU admission during the core studies
- Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core study
- Development of uncontrolled asthma during the core study that could compromise the safety of the participants judged by the investigator
- Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator
- Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion they should not participate in this extension study
- Platelets <75,000/ul at EoT of the core study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall incidence and exposure-adjusted occurrence rates of treatment-emergent AEs and SAEs
Secondary endpoints 3
- Proportion of participants tolerating a single dose of ≥ 600 mg of peanut protein without dose limiting symptoms during an open label OFC at scheduled timepoints
- Overall incidence and exposure-adjusted occurrence rates of treatment-emergent AEs and SAEs
- Summaries of total scores in the FAQLQ, FAIM and SF-36v2 by age and responder (participants and/or caregiver) at scheduled timepoints
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10319937 · Product
- Active substance
- Ligelizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 9600 mg milligram(s)
- Max treatment duration
- 156 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
placebo to QGE031 120 mg/ mL solution for injection in pre-filled syringe
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 7
PRD10293222 · Product
- Active substance
- Defatted Powder of Arachis Hypogaea L., Semen (Peanuts)
- Pharmaceutical form
- GRANULES FOR ORAL SUSPENSION
- Route of administration
- ORAL USE
- Max daily dose
- 5044 mg milligram(s)
- Max total dose
- 45396 mg milligram(s)
- Max treatment duration
- 9 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10293241 · Product
- Active substance
- Defatted Powder of Arachis Hypogaea L., Semen (Peanuts)
- Pharmaceutical form
- GRANULES FOR ORAL SUSPENSION
- Route of administration
- ORAL USE
- Max daily dose
- 5044 mg milligram(s)
- Max total dose
- 45396 mg milligram(s)
- Max treatment duration
- 9 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
-
V04CL · Product
- Pharmaceutical form
- PHF00024MIG
- Route of administration
- INTRAEPIDERMAL USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06568MIG · Substance
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 0.9 mg milligram(s)
- Max total dose
- 1083.60 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06568MIG · Substance
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 0.9 mg milligram(s)
- Max total dose
- 1083.60 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10422MIG · Substance
- Active substance
- Salbutamol
- Pharmaceutical form
- NEBULISER SOLUTION
- Route of administration
- INHALATION USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 24080 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10422MIG · Substance
- Active substance
- Salbutamol
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 24080 mg milligram(s)
- Max treatment duration
- 172 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 18
| Organisation | City, country | Duties |
|---|---|---|
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Creapharm Clinical Supplies ORG-100020131
|
Reims, France | Other |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Phardis S.r.l. ORG-100019559
|
Calvenzano, Italy | Other |
| Icon Clinical Research (U.K.) Limited ORG-100008610
|
Marlow, United Kingdom | Code 10 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Other |
| Somalogic Operating Co. Inc. ORG-100042788
|
Boulder, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Interactive response technologies (IRT) |
| Iqvia Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Emsere B.V. ORG-100046660
|
Leiden, Netherlands | Other |
| Myonex Limited ORG-100015937
|
Leicester, United Kingdom | Other |
| Kayentis ORG-100037894
|
Meylan, France | Other |
| Opis S.r.l. ORG-100011127
|
Desio, Italy | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
| Charles River Laboratories France C.R.L.F. ORG-100011847
|
Saint-Germain-Nuelles, France | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
Locations
5 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 5 |
| Germany | Ended | 25 | 5 |
| Italy | Ended | 2 | 2 |
| Netherlands | Ended | 6 | 1 |
| Spain | Ended | 10 | 6 |
| Rest of world
South Africa, United Kingdom, Japan, Canada, United States, Australia
|
— | 495 | — |
Investigational sites
Centre Hospitalier Universitaire D Angers
3010:Allergology, 4 Rue Larrey, 49933, Angers Cedex 9
Les Hopitaux Universitaires De Strasbourg
3011:Asthma and allergology-Pneumology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Lille
3013:Pediatric, Avenue Eugene Avinee, 59000, Lille
Centre Hospitalier Universitaire De Toulouse
3012:Pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
CHRU De Nancy
3014:Pediatric - Allergology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Technische Universitat Dresden
3200: Kinderklinik, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Medaimun GmbH
3204: Medaimun GmbH, Kennedyallee 97a, Sachsenhausen, Frankfurt Am Main
Charite Universitaetsmedizin Berlin KöR
3203: Klinik für Dermatologie, Venerologie und Allergologie, Chariteplatz 1, Mitte, Berlin
Charite Universitaetsmedizin Berlin KöR
3201: Klinik fur Paediatrie m. S. Pneumologie, lmmunologie und lntensivmedizin, Augustenburger Platz 1, Wedding, Berlin
Goethe University Frankfurt
3202: Universitaetsklinikum Frankfurt Klinik fuer Kinder- und Jugendmedizin, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Bambino Gesu Childrens Hospital
3021:UOC Allergologia, Piazza Sant'onofrio 4, 00165, Rome
Azienda Ospedale-Universita Padova
3020:UOSD Allergie Alimentari Adulto e Pediatriche, Via Nicolo' Giustiniani 2, 35128, Padova
University Medical Center Utrecht
3030: Reumatologie/Klin. Immunologie en Dermatologie, Heidelberglaan 100, 3584 CX, Utrecht
Hospital Infantil Universitario Nino Jesus
3101:Servicio alergología, Avenida Menendez Pelayo 65, 28009, Madrid
Hospital Clinic De Barcelona
3104:Servicio alergología, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario Gregorio Maranon
3105:Servicio alergología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
3103:Servicio alergología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Fundacio Sant Joan De Deu
3102:Servicio alergología, Calle Santa Rosa 39-57 3a Planta, 08950, Esplugues De Llobregat
Hospital Clinico San Carlos
3100:Servicio alergología, Calle Del Profesor Martin Lagos S/n, 28040, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-09-26 | 2023-09-26 | 2024-08-05 | ||
| Germany | 2023-09-11 | 2023-09-11 | 2024-08-05 | ||
| Italy | 2024-01-29 | 2024-01-29 | 2024-08-05 | ||
| Netherlands | 2023-10-18 | 2023-10-18 | 2024-08-05 | ||
| Spain | 2023-10-05 | 2023-10-05 | 2024-08-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 5 · Art. 38 CTR
Temporary halt TH-39368
- Halt date
- 2024-08-05
- Member states concerned
- France
- Publication date
- 2024-08-07
- Reason
- Sponsor decision
- Explanation
- Business decision
- Follow-up measures
- Early termination of the study is planned. Patients will complete the end of treatment visit within approximately 4-6 weeks prior to transitioning to the 16-week safety follow-up period. End of Study will be declared when the last patient completes the 16-week wash-out period.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-39346
- Halt date
- 2024-08-05
- Member states concerned
- Netherlands
- Publication date
- 2024-08-07
- Reason
- Sponsor decision
- Explanation
- Business decision
- Follow-up measures
- Early termination of the study is planned. Patients will complete the end of treatment visit within approximately 4-6 weeks prior to transitioning to the 16-week safety follow-up period. End of Study will be declared when the last patient completes the 16-week wash-out period.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-39366
- Halt date
- 2024-08-05
- Member states concerned
- Germany
- Publication date
- 2024-08-07
- Reason
- Sponsor decision
- Explanation
- Business decision
- Follow-up measures
- Early termination of the study is planned. Patients will complete the end of treatment visit within approximately 4-6 weeks prior to transitioning to the 16-week safety follow-up period. End of Study will be declared when the last patient completes the 16-week wash-out period.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-39364
- Halt date
- 2024-08-05
- Member states concerned
- Italy
- Publication date
- 2024-08-07
- Reason
- Sponsor decision
- Explanation
- Business decision
- Follow-up measures
- Early termination of the study is planned. Patients will complete the end of treatment visit within approximately 4-6 weeks prior to transitioning to the 16-week safety follow-up period. End of Study will be declared when the last patient completes the 16-week wash-out period.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-39361
- Halt date
- 2024-08-05
- Member states concerned
- Spain
- Publication date
- 2024-08-07
- Reason
- Sponsor decision
- Explanation
- Business decision
- Follow-up measures
- Early termination of the study is planned. Patients will complete the end of treatment visit within approximately 4-6 weeks prior to transitioning to the 16-week safety follow-up period. End of Study will be declared when the last patient completes the 16-week wash-out period.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| CQGE031G12303B summary of results SUM-96607
|
2025-09-04T19:01:21 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| CQGE031G1230B_Adult Patient Summary-English-US | 2025-09-03T14:59:43 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Pediatric Patient Summary-English-US | 2025-09-03T14:59:37 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Adult Patient Summary_Dutch | 2025-11-14T11:28:09 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Adult Patient Summary-French-Canada | 2025-11-14T11:28:27 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Adult Patient Summary-Italian | 2025-11-14T11:28:49 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Adult Patient Summary-Japanese | 2025-11-14T11:29:05 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Adult Patient Summary-Spanish-Spain | 2025-11-14T11:29:21 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Pediatric Patient Summary-Dutch | 2025-11-14T11:30:17 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Pediatric Patient Summary-French-Canada | 2025-11-14T11:30:30 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Pediatric Patient Summary-French-France | 2025-11-14T11:30:43 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Adult Patient Summary-French-France | 2025-11-14T11:29:36 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Pediatric Patient Summary-German-Germany | 2025-11-14T11:30:58 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Adult Patient Summary-German-Germany | 2025-11-14T11:29:54 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Pediatric Patient Summary-Italian | 2025-11-14T11:31:08 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Pediatric Patient Summary-Japanese | 2025-11-14T11:31:21 | Submitted | Laypersons Summary of Results |
| CQGE031G12303B_Pediatric Patient Summary-Spanish-Spain | 2025-11-14T11:31:31 | Submitted | Laypersons Summary of Results |
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | CQGE031G12303B_PatientSummary_Dutch | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PatientSummary_English-US_29Aug2025 | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PatientSummary_French-Canada | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PatientSummary_French-France | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PatientSummary_German-Germany | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PatientSummary_Italian | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PatientSummary_Japanese | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PatientSummary_Spanish-Spain | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PediatricPatientSummary_Dutch | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PediatricPatientSummary_English-US_29Aug2025 | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PediatricPatientSummary_French-Canada | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PediatricPatientSummary_French-France | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PediatricPatientSummary_German-Germany | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PediatricPatientSummary_Italian | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PediatricPatientSummary_Japanese | 1 |
| Laypersons summary of results (for publication) | CQGE031G12303B_PediatricPatientSummary_Spanish-Spain | 1 |
| Summary of results (for publication) | CQGE031G12303B summary of results | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-28 | France | Acceptable 2023-08-21
|
2023-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-01 | France | Acceptable 2024-02-16
|
2024-02-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-24 | France | Acceptable 2024-06-07
|
2024-06-11 |