Peanut AllergyNCT05163574
Induction of Sustained Unresponsiveness to Peanuts Using High- and Low-dose Peanut Oral Immunotherapy
A study testing High dose OIT and Low dose OIT in people with Peanut Allergy, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This study is a continuation of a clinical trial NCT044155930 comparing the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) and will involve patients who have accomplished their per-protocol participation in that trial. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- High dose OIT and Low dose OIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 5 Feb 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients who have accomplished their per-protocol participation in trial NCT044155930.
- signed Informed Consent by parent/legal guardian and patient aged>16 years old
- patient's/caregiver's cooperation with researcher
Who cannot join
- severe asthma
- uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5 percentile), FEV1/forced vital capacity (FEV)<75% (under 5 percentile), hospitalization due to asthma exacerbation within last 12 months
- current oral/sublingual/subcutaneous immunotherapy with another allergen
- eosinophilic esophagitis
- allergic reaction of 4th or higher grade according to the World Allergy Organisation Systemic Allergic Reaction Grading System during immunotherapy
- a history of severe recurrent anaphylaxis episodes
Show all 17Show fewer
- chronic diseases requiring continous treatment, including heart disease, epilepsy, metabolic disease, diabetes
- medication:
- oral, daily steroid therapy exceeding 1 month within the last 12 months
- at least two courses of oral steroid therapy (at least 7 days) within the last 12 months
- oral steroid therapy longer than 7 days within the last 3 months
- biological treatment
- the need to constantly take antihistamines
- therapy with b-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors
- pregnancy
- no consent to participate in the study
- lack of patient cooperation
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
Warsaw
Wioletta Zagórska, PhD, MD, wiola.zagorska@gmail.com
Magdalena Chojnowska-Wójtowicz, MD
About this study
Official title: Induction of Sustained Unresponsiveness to Peanuts Using High- and Low-dose Peanut Oral Immunotherapy - Evaluation of Efficacy and Safety
This study is a continuation of a clinical trial NCT044155930 comparing the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) and will involve patients who have accomplished their per-protocol participation in that trial.
The aim of current study is to assess a sustained unresponsiveness (SU) to allergen protein after at least 8 months of previously assigned high- or low-dose peanut OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).
Read the detailed description
Oral immunotherapy is considered the most effective food allergy treatment. There are two main goals of food immunotherapy: achievement of desensitisation and sustained unresponsiveness. Desensitization is a temporary state of clinical non-reactivity which requires regular intake of allergen, whereas sustained unresponsiveness is defined as lack of clinical reaction to a food allergen after discontinuing OIT for a specific period of time.
The study is a continuation of a clinical trial NCT044155930, which was designed to compare the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) in children with a confirmed diagnosis of peanut allergy. The participants of current study will be recruited from patients who have accomplished their per-protocol participation in previous trial.
Patients will receive the same maintenance dose of peanut allergen, which was used in previous trial (150 or 300 mg, respectively), for at least 8 months (32 weeks +/-2 weeks). Then, OIT will be discontinued for 4 weeks with strict peanut avoidance. After this period, an open oral food challenge (OOFC) will be performed to assess the achievement of sustained unresponsiveness.
- Conditions
- Peanut Allergy
- Being tested
- High dose OIT, Low dose OIT
- Keywords
- peanut, food allergy, sustained unresponsiveness, children
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose OITDietary supplement
Patients will receive daily a high dose of peanut flour (300 mg peanut protein) mixed with well-tolerated fruit mousse.
Low dose OITDietary supplement
Patients will receive daily a low dose of peanut flour (150 mg peanut protein) mixed with well-tolerated fruit mousse.
| Study group | Role | What they receive |
|---|---|---|
| High dose | Experimental | 20 patients Receives: Dietary Supplement: High dose OIT |
| Low dose | Active comparator | 20 patients Receives: Dietary Supplement: Low dose OIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained unresponsiveness to a peanut protein after discontinuing oral immunotherapy for 4 weeks.
The share of participants who tolerate a single dose of 150 mg or 300 mg of peanut protein (depending on the maintenance dose) at oral food challenge.
Measured: Up to 9 months after starting maintenance phase
The highest tolerated dose of peanut protein after discontinuing oral immunotherapy for 4 weeks.
Sustained unresponsiveness assessed as the highest tolerated dose of peanut protein at oral food challenge.
Measured: Up to 9 months after starting maintenance phase
Secondary outcomes (4)
Adverse events
Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups.
Measured: Up to 9 months after starting maintenance phase
Occurence of eosinophilic esophagitis.
Number and severity of eosinophilic esophagitis symptoms following OIT treatment assessed and compared between both groups.
Measured: Up to 9 months after starting maintenance phase
Laboratory data
Change in serum levels of specific immunoglobulin E (sIgE) to peanut components and peanut-specific immunoglobulin G4 (sIgE4) levels at different time points: at the start and at the end of oral immunotherapy, and after 4 weeks of allergen avoidance, assessed for each individual and compared between groups.
Measured: Up to 9 months after starting maintenance phase
Skin prick test (SPT)
Change in peanut skin prick test wheal in different time points: at the start, and at the end of oral immunotherapy, and after 4 weeks of allergen avoidance, assessed for each individual and compared between groups.
Measured: Up to 9 months after starting maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start5 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Grzela, MD, PhD, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163574
- Sponsor's protocol ID
- Sustained unresponsiveness
- Status last verified
- Jul 2023
- First submitted
- 6 Dec 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burks AW, Sampson HA, Plaut M, Lack G, Akdis CA. Treatment for food allergy. J Allergy Clin Immunol. 2018 Jan;141(1):1-9. doi: 10.1016/j.jaci.2017.11.004.
PubMed 29307409Nagakura KI, Yanagida N, Sato S, Nishino M, Asaumi T, Ogura K, Ebisawa M. Low-dose oral immunotherapy for children with anaphylactic peanut allergy in Japan. Pediatr Allergy Immunol. 2018 Aug;29(5):512-518. doi: 10.1111/pai.12898. Epub 2018 May 10.
PubMed 29603410PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18.
PubMed 30449234Patrawala M, Shih J, Lee G, Vickery B. Peanut Oral Immunotherapy: a Current Perspective. Curr Allergy Asthma Rep. 2020 Apr 20;20(5):14. doi: 10.1007/s11882-020-00908-6.
PubMed 32314071Rodriguez Del Rio P, Escudero C, Sanchez-Garcia S, Ibanez MD, Vickery BP. Evaluating primary end points in peanut immunotherapy clinical trials. J Allergy Clin Immunol. 2019 Feb;143(2):494-506. doi: 10.1016/j.jaci.2018.09.035. Epub 2018 Oct 24.
PubMed 30367908
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Sustained Unresponsiveness to Peanuts Using High- and Low-dose Peanut Oral Immunotherapy - Evaluation of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05163574
- Acronym / sponsor ID
- Sustained unresponsiveness
- Conditions
- Peanut Allergy
- Keywords
- peanut, food allergy, sustained unresponsiveness, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a continuation of a clinical trial NCT044155930 comparing the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) and will involve patients who have accomplished their per-protocol participation in that trial.
The aim of current study is to assess a sustained unresponsiveness (SU) to allergen protein after at least 8 months of previously assigned high- or low-dose peanut OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).
Detailed description
Oral immunotherapy is considered the most effective food allergy treatment. There are two main goals of food immunotherapy: achievement of desensitisation and sustained unresponsiveness. Desensitization is a temporary state of clinical non-reactivity which requires regular intake of allergen, whereas sustained unresponsiveness is defined as lack of clinical reaction to a food allergen after discontinuing OIT for a specific period of time.
The study is a continuation of a clinical trial NCT044155930, which was designed to compare the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) in children with a confirmed diagnosis of peanut allergy. The participants of current study will be recruited from patients who have accomplished their per-protocol participation in previous trial.
Patients will receive the same maintenance dose of peanut allergen, which was used in previous trial (150 or 300 mg, respectively), for at least 8 months (32 weeks +/-2 weeks). Then, OIT will be discontinued for 4 weeks with strict peanut avoidance. After this period, an open oral food challenge (OOFC) will be performed to assess the achievement of sustained unresponsiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose | Experimental | Dietary Supplement: High dose OIT20 patients |
| Low dose | Active comparator | Dietary Supplement: Low dose OIT20 patients |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients who have accomplished their per-protocol participation in trial NCT044155930.
- signed Informed Consent by parent/legal guardian and patient aged>16 years old
- patient's/caregiver's cooperation with researcher
Key exclusion criteria (17 listed)
- severe asthma
- uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5 percentile), FEV1/forced vital capacity (FEV)<75% (under 5 percentile), hospitalization due to asthma exacerbation within last 12 months
- current oral/sublingual/subcutaneous immunotherapy with another allergen
- eosinophilic esophagitis
- allergic reaction of 4th or higher grade according to the World Allergy Organisation Systemic Allergic Reaction Grading System during immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose OITPatients will receive daily a high dose of peanut flour (300 mg peanut protein) mixed with well-tolerated fruit mousse. | Dietary supplement | High dose |
| Low dose OITPatients will receive daily a low dose of peanut flour (150 mg peanut protein) mixed with well-tolerated fruit mousse. | Dietary supplement | Low dose |
Primary outcome
Sustained unresponsiveness to a peanut protein after discontinuing oral immunotherapy for 4 weeks.
Time frame: Up to 9 months after starting maintenance phase
The share of participants who tolerate a single dose of 150 mg or 300 mg of peanut protein (depending on the maintenance dose) at oral food challenge.
The highest tolerated dose of peanut protein after discontinuing oral immunotherapy for 4 weeks.
Time frame: Up to 9 months after starting maintenance phase
Sustained unresponsiveness assessed as the highest tolerated dose of peanut protein at oral food challenge.
4 secondary outcomes
Adverse events
Time frame: Up to 9 months after starting maintenance phase
Occurence of eosinophilic esophagitis.
Time frame: Up to 9 months after starting maintenance phase
Laboratory data
Time frame: Up to 9 months after starting maintenance phase
Skin prick test (SPT)
Time frame: Up to 9 months after starting maintenance phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 29307409Burks AW, Sampson HA, Plaut M, Lack G, Akdis CA. Treatment for food allergy. J Allergy Clin Immunol. 2018 Jan;141(1):1-9. doi: 10.1016/j.jaci.2017.11.004.
- Background: PubMed 29603410Nagakura KI, Yanagida N, Sato S, Nishino M, Asaumi T, Ogura K, Ebisawa M. Low-dose oral immunotherapy for children with anaphylactic peanut allergy in Japan. Pediatr Allergy Immunol. 2018 Aug;29(5):512-518. doi: 10.1111/pai.12898. Epub 2018 May 10.
- Background: PubMed 30449234PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18.
- Background: PubMed 32314071Patrawala M, Shih J, Lee G, Vickery B. Peanut Oral Immunotherapy: a Current Perspective. Curr Allergy Asthma Rep. 2020 Apr 20;20(5):14. doi: 10.1007/s11882-020-00908-6.
- Background: PubMed 30367908Rodriguez Del Rio P, Escudero C, Sanchez-Garcia S, Ibanez MD, Vickery BP. Evaluating primary end points in peanut immunotherapy clinical trials. J Allergy Clin Immunol. 2019 Feb;143(2):494-506. doi: 10.1016/j.jaci.2018.09.035. Epub 2018 Oct 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Grzela, MD, PhD study chair
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose OIT and Low dose OIT in people with Peanut Allergy, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Chojnowska-Wójtowicz, MD (22-317-9431, magdalena.chojnowska@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained unresponsiveness to a peanut protein after discontinuing oral immunotherapy for 4 weeks. (time frame: Up to 9 months after starting maintenance phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05163574, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.