Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).

NCT03964051 | Terminated Phase 4 DMC

• 1 other identifier: 2017-003627-30
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. However, novel treatments altering the clinical reactivity to the offending food thereby diminishing the risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum towards the offending food and the clinical sensitivity of the patient has been suggested. The clinical threshold for a food allergic reaction to occur is therefore hypothesized to increase by reducing the level of specific IgE to the relevant food allergen. Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of this study is to investigate if the combination of initial IgE specific immunoadsorption combined with subsequent treatment with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe food allergy.

Conditions

Food Allergy

Keywords

Omalizumab; Xolair; Anaphylaxis

Outcome Measures

Primary Outcomes (1)

• Change in food challenge threshold (as measured in amount of food protein in milligrams tolerated by oral challenge)

  As described open food challenges will be performed according to international guidelines (1) at specified time points and thresholds for a clinical objective reaction as measured in milligrams food protein before (Tr0) and after (TrP) the initial immunoadsorption and then during (TrX) and after cessation (TrW) of treatment with Omalizumab. Challenge thresholds at Tr0, TrP, TrX and TrW will be reported for each patient and compared. Since the study is non-randomized and uncontrolled the individual patient will serve as his/her own control. A 2-step change in threshold will be considered significant.

  18 weeks

Secondary Outcomes (1)

• Change in SPT size (mm) and levels of s-IgE, t-IgE and BaHR

  18 weeks

Study Arms (1)

Omalizumab 300 mg for s.c.injection

EXPERIMENTAL

Omalizumab 300 mg steril solution in prefilled syringes are administrated every 2. week for 12 weeks

Drug: Omalizumab Injection

Interventions

Omalizumab Injection DRUG

Omalizumab 300 mg for subcutaneous injection

Also known as: Xolair 300 mg

Omalizumab 300 mg for s.c.injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 - 70 years with verified allergy to a food allergen, where validated methods for determination of specific IgE to the food and to the major allergens (Component Resolved Diagnostics) are available. The foods include, but will not be confined to milk, egg, peanut, hazelnut, sesame, wheat, cod and shrimp. Patients with/without elevated levels of total IgE (\> 1000 kIU/l) will be included. Minimum level of specific IgE to the major allergen component in the food in question will be 10 kIU/l. No control group will be included.

You may not qualify if:

• Ischemic heart disease or other significant co-morbidity (e.g. uncontrolled asthma) that might compromise the patient's safety or study outcomes.
• Infection on the day of study
• Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused three days prior to the tests
• Ongoing treatment with β-blockers that cannot be paused one day prior to the tests
• Ongoing treatment with oral glucocorticoids (\>10 mg daily)
• Alcohol abuse, abuse of opioids or other drugs
• Occurrence of unexpected side effects
• Patients who are not supposed to be able to meet the requirements in the protocol
• Patients who are physically or mentally unable to consent
• Patients who have reduced liver function or kidney function

Sponsors & Collaborators

• Carsten Bindslev-Jensen: lead
• Miltenyi Biomedicine GmbH: collaborator

Study Sites (1)

Odense Research Center for Anaphylaxis, Allergy Center

Odense C, Funen, 5000, Denmark

Location

Related Publications (1)

• Bindslev-Jensen C, Ballmer-Weber BK, Bengtsson U, Blanco C, Ebner C, Hourihane J, Knulst AC, Moneret-Vautrin DA, Nekam K, Niggemann B, Osterballe M, Ortolani C, Ring J, Schnopp C, Werfel T; European Academy of Allergology and Clinical Immunology. Standardization of food challenges in patients with immediate reactions to foods--position paper from the European Academy of Allergology and Clinical Immunology. Allergy. 2004 Jul;59(7):690-7. doi: 10.1111/j.1398-9995.2004.00466.x. No abstract available.

  PMID: 15180754 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity; Anaphylaxis

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Carsten Bindslev-Jensen, ProfDrMedPhd

  Odense Research Center for Anaphylaxis

  STUDY DIRECTOR

• Charlotte G. Moertz, ProfMDPhd

  Odense Research Center for Anaphylaxis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, M.D, Dr.Med., Ph.d.,

Model Details: 10 patients with severe food allergy will receive subcutaneous injections of Omalizumab 300 mg every 2 week for 12 weeks.

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 28, 2019
• Study Start: July 1, 2019
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

DK (1)