A Phase 4 interventional study of Omalizumab Injection in Food Allergy, sponsored by Carsten Bindslev-Jensen. Terminated at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Carsten Bindslev-Jensen · Phase 4, Interventional, and Treatment
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.
10 patients with a proven food allergy will be submitted to the combined effort of IgE specific (selective) immunoadsorption and subsequent treatment with Omalizumab.
An Oral Food Challenge (OFC) will be performed before, during and after the above mentioned treatments according to international guidelines with administration of increasing doses (3, 10, 30, 100, 300, 1000 and 3000 mg of protein) of the incriminated food at one hour intervals, until objective signs of an allergic reaction in the patient occur. The cumulated dose eaten before this reaction is defined as the threshold (Tr).
The patient's threshold value (mg protein) before therapy (Tr0) will be determined by OFC immediately before three cycles of immunoadsorption on three consecutive days are performed. This repeated procedure will expectedly reduce the serum level of IgE (total as well as specific) by a factor of at least 10. Immediately after the last day of immunoadsorption, a second OFC for determination of threshold (TrP) will be performed and compared to Tr0, in order to determine the efficacy of the immunoadsorption.
Immediately after finalization of the second OFC, treatment with Omalizumab 300 mg s.c. injection will be initiated and repeated every 2 weeks until 12 weeks of treatment has been reached. The administration, the dose and dose interval is the recommended dosage as to the SPC (Summary of Product Characteristics). Treatment with Omalizumab will expectedly reduce the level of serum IgE (total as well as specific) by a factor of 2-4. The day following the final administration of Omalizumab, a third OFC for determination of threshold (TrX) will be performed and followed by a fourth OFC for determination of threshold (TrW) four weeks later. These thresholds will be compared to Tr0 and TrP to determine the combined efficacy of immunoadsorption and therapy with Omalizumab during therapy and after cessation of therapy.
Skin Prick Tests (SPTs), serum levels of total (t-IgE) and specific IgE (s-IgE) as well as relevant component resolved diagnostics (all in kIU/L) and Basophil Histamine Release (BaHR) (ng/mL) for relevant food allergens will be determined immediately before and after immunoadsorption, before challenges and before administration of Omalizumab.
Provided that 80 % of the patients will respond to immunoadsorption and therapy with Omalizumab (i.e. a comparison between Tr0 and TrX) with at least a two-step increase in threshold, a number of 10 included patients will result in a statistical significance for difference between the two parameters of 0.0047, if the remaining two patients do not change their threshold values. If, additionally one patient decreases threshold (i.e. 7 positive, 2 unchanged and 1 negative), the value will still be statistically significant (p=0.0142) using the Wilcoxon signed-rank test. The specified number of patients have to complete the study to ensure the results.
GCP-monitoring is performed by the local GCP-unit at Odense University Hospital.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Carsten Bindslev-Jensen is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Omalizumab 300 mg steril solution in prefilled syringes are administrated every 2. week for 12 weeks
Drug: Omalizumab Injection
Omalizumab 300 mg for subcutaneous injection
Also known as: Xolair 300 mg
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.
Time frame: 18 weeks
Change in SPT size (mm) and levels of s-IgE, t-IgE and BaHR
At the specified time points (Tr0, TrP, TrX and TrW) SPT and measurement of specific IgE and component resolved diagnostics (for relevant allergens for the individual patient), total IgE and BaHR will be measured and compared. Since the study is non-randomized and uncontrolled the individual patient will serve as his/her own control. The immunological changes will be correlated to the corresponding thresholds (the primary outcome). An inverse correlation is expected (reduced immunological response expected to correlate with increased thresholds).
Time frame: 18 weeks
Ran from Jul 2019 to primary completion in Dec 2020, 17 months.
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This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omalizumab
Carsten Bindslev-Jensen