Clinical trial • Phase IV • Other

OMALIZUMAB for Food allergy (LTP sensitization) | Food allergy (profilin sensitization)

Phase IV trial of OMALIZUMAB for Food allergy (LTP sensitization) | Food allergy (profilin sensitization). 37 participants.

Overview

Trial Therapeutic Area: Other
Trial Disease: Food allergy (LTP sensitization) | Food allergy (profilin sensitization)
Trial Stage: Phase IV
Drug Modality: Monoclonal antibody
Paediatric Trial: Yes

Phase IV trial across 1 site in Spain.

Recruits 37 paediatric patients.

Pregnancy Exclusion: Pregnancy and lactation.
Vulnerable Population: Vulnerable population selected. Study includes minors (age 14-17) within the inclusion age range. Informed consent required for study participation and Biobank sample storage. Assent and parental consent documents are present among submitted documents (e.g. "HIPAsentiemiento V1 IDOMA2025" for assent; "13 HIPCIPadres RL V1 IDOMA2025" for parental/guardian consent), and multiple subject information and informed consent form documents are provided.

{"criterion_text":"- Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.\n- lant food allergy due to sensitisation to LTP, patients allergic to profilin confirmed by suggestive clinical history, positive skin tests and specific IgE to Pru p 3 (peach LTP) and Pho d 2 (Phoenix dactylifera profilin).\n- Positive oral challenge test (OCT) to peach and at least one other food in patients allergic to LTP and positive oral challenge test to melon and at least one other food in patients allergic to profilin.\n- Selection of a group of LTP-allergic individuals with therapeutic failure after treatment with ITSL-Pru p 3."}

{"criterion_text":"- Pregnancy and lactation.\n- Immunological diseases; treatment with immunomodulatory and/or blocking drugs.\n- Mental illness, which makes it impossible to follow and adhere to treatment (e.g. major depression, psychosis, etc.).\n- Severe atopic dermatitis according to SCORAD 5: FEV1<70% (this test will be carried out as a priority in patients with a previous diagnosis of asthma).\n- Inflammation in the oral cavity with severe symptoms, as well as with oral surgery in the previous 7 days.\n- Immunotherapy with pollens in the previous 2 years.\n- Subjects unable to comply with the schedule of visits during the study, as well as for the consumption of the food under investigation, e.g. due to work-related difficulties."}

{"endpoint_text":"- Clinical efficacy defined as an increase in the amounts of peach in patients allergic to LTP and melon in patients allergic to apple tolerated in PPO after 16 weeks of treatment with omalizumab.","definition_or_measurement_approach":"Clinical efficacy measured as increase in amounts of specified foods tolerated on controlled oral provocation (PPO) after 16 weeks of omalizumab treatment."}

{"endpoint_text":"- Clinical efficacy defined as an increase in the amounts of at least 1 other food related to sensitisation to LTP (quantitative).","definition_or_measurement_approach":"Quantitative increase in tolerated amounts of at least one additional LTP-related food, measured by controlled oral provocation (PPO)."}
{"endpoint_text":"- Clinical efficacy defined as an increase in the amounts of at least 1 more food related to sensitisation to profilin (quantitative).","definition_or_measurement_approach":"Quantitative increase in tolerated amounts of at least one additional profilin-related food, measured by controlled oral provocation (PPO)."}
{"endpoint_text":"- Analysis of quality of life before and after treatment with omalizumab.","definition_or_measurement_approach":"Quality of life assessed pre- and post-treatment (specific instrument not specified in available data)."}

Planned Sample Size: 37
Recruitment Window Months: 13
Consent Approach: Informed consent required; participants must sign informed consent for the study and for Biobank sample storage. Subject information and informed consent form documents submitted (examples: "HIP-CIV1 IDOMA2025", "10 HIP CIV3 IDOMA2025"). Assent and parental consent documents are included for minors (e.g. "HIPAsentiemiento V1 IDOMA2025" and "13 HIPCIPadres RL V1 IDOMA2025"). Documents available in Spanish and English (protocol/title translations and protocol English version present).

Full Name: Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
Organisation Type: Laboratory/Research/Testing facility
Country Of Registered Address: Spain

Investigational Product Name: Omlyclo 75 mg solution for injection in pre-filled syringe
Active Substance: OMALIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: INJECTION
Route: INJECTION
Authorisation Status: Marketing authorisation EU/1/24/1817/001

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