Food AllergyPhase 1/2NCT04856865

ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

A Phase 1/2 study testing Low dose ADP101 and High dose ADP101 in people with Food Allergy, run by Alladapt Immunotherapeutics, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults. Read more about this study

Who is it for?: Ages 4 to 55 years
Conditions the study is for: Food Allergy
What is being tested?: Low dose ADP101 and High dose ADP101
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 73 participants
Where: 15 sitesUnited States
Study dates: 20 Apr 2021to 13 Dec 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 4 to 55 (inclusive)
Clinical history of allergy to at least 1 of the foods contained in ADP101
Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple food sources in ADP101

Who cannot join

Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101
History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening
History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
Severe asthma
Mild or moderate asthma, if uncontrolled or difficult to control
History of mast cell disorder, including mastocytosis, urticaria pigmentosa or angioedema

Show all 22Show fewer

History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic regimen e.g. uncontrolled diabetes
History of cardiovascular disease, including hypertension requiring > 2 antihypertensive medications
History of interstitial lung disease
History of celiac disease
Active autoimmune disease that has required systemic treatment within 3 months
Known malignancy that is progressing or has required active treatment within the past 3 years
Known history of HIV, known active hepatitis B infection or known active hepatitis C virus infection
Prior/concurrent therapies as follows:
beta-blockers, ACE inhibitors, ARBs or calcium channel blockers
regular steroid medication use
therapeutic antibody treatment currently or within the previous 6 months
any food immunotherapy currently or within the previous 12 weeks
In the build up phase of non-food immunotherapy
Residing at the same address as another subject (e.g. siblings) participating in this or any other OIT study
Develops dose-limiting symptoms to placebo during the Screening DBPCFC
Any other condition that might preclude safe participation in the study

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study Site
Ann Arbor, Michigan, 48108
Study Site
Atlanta, Georgia, 30329
Study Site
Chapel Hill, North Carolina, 27599
Study Site
Charleston, South Carolina, 29420
Study Site
Cincinnati, Ohio, 45229
Study Site
Denver, Colorado, 80230
Study Site
Happy Valley, Oregon, 97086
Study Site
Marietta, Georgia, 30060
Study Site
Mission Viejo, California, 92691
Study Site
Normal, Illinois, 61761
Study Site
Philadelphia, Pennsylvania, 19104
Study Site
Rolling Hills Estates, California, 90274
Study Site
San Diego, California, 92123
Study Site
Seattle, Washington, 98115
Study Site
Tampa, Florida, 33620

Other trials in United States

About this study

Official title: A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Harmony Study)

The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ADP101 for oral immunotherapy in food allergic children and adults.

Conditions: Food Allergy
Being tested: Low dose ADP101, High dose ADP101, Pooled Placebo
Keywords: ADP101, Allergy, Oral immunotherapy, OIT, Allergies, Food allergies, Multi-food allergic, Multi-allergen oral immunotherapy, Tree nut allergy, Milk allergy, Wheat allergy, Egg allergy, Fin fish allergy, Shrimp allergy, Peanut allergy, Sesame seed allergy, Soy allergy, Shellfish allergy, Fish allergy, Seafood allergy
Medical subject headings: Food Hypersensitivity, Hypersensitivity, Nut Hypersensitivity, Milk Hypersensitivity, Wheat Hypersensitivity, Egg Hypersensitivity, Peanut Hypersensitivity, Shellfish Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low dose ADP101Biological
Also called 1500mg target dose ADP101
Active powder formulation
High dose ADP101Biological
Also called 4500mg target dose ADP101
Active powder formulation.
Pooled PlaceboBiological
Also called Placebo
Placebo powder

Study groups in NCT04856865
Study group	Role	What they receive
Low dose ADP101	Experimental	Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. Receives: Biological: Low dose ADP101
High dose ADP101	Experimental	Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. Receives: Biological: High dose ADP101
Pooled Placebo	Experimental	Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active. Receives: Biological: Pooled Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

600mg Desensitization in at Least One Qualifying Food
The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.
Measured: 40 Weeks

Secondary outcomes (3)

1000mg Desensitization Threshold in Pediatric ITT Population
Proportion of participants in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.
Measured: 40 weeks
600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
Proportion of participants with >=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 600mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC.
Measured: 40 weeks
1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
Proportion of participants with >=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC.
Measured: 40 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 202113 Dec 2022

First posted23 Apr 2021
Study start20 Apr 2021
Primary completion22 Nov 2022
Study completion13 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Food AllergyStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04856865
Sponsor's protocol ID: ADP101-MA-01
Status last verified: May 2024
First submitted: 20 Apr 2021
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
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Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
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All Food Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Harmony Study)
ClinicalTrials.gov ID: NCT04856865
Acronym / sponsor ID: ADP101-MA-01
Conditions: Food Allergy
Keywords: ADP101, Allergy, Oral immunotherapy, OIT, Allergies, Food allergies, Multi-food allergic, Multi-allergen oral immunotherapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Alladapt Immunotherapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 20 Apr 2021 (actual)
Primary completion: 22 Nov 2022 (actual)
Study completion: 13 Dec 2022 (actual)
First posted: 23 Apr 2021 (actual)
Results: Posted 16 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ADP101 for oral immunotherapy in food allergic children and adults.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low dose ADP101	Experimental	Biological: Low dose ADP101Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
High dose ADP101	Experimental	Biological: High dose ADP101Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
Pooled Placebo	Experimental	Biological: Pooled PlaceboParticipants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.

Who may qualify

Ages: 4 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Age 4 to 55 (inclusive)
Clinical history of allergy to at least 1 of the foods contained in ADP101
Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple food sources in ADP101

Key exclusion criteria (22 listed)

Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101
History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening
History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
Severe asthma
Mild or moderate asthma, if uncontrolled or difficult to control

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
Low dose ADP101Also: 1500mg target dose ADP101Active powder formulation	Biological	Low dose ADP101
High dose ADP101Also: 4500mg target dose ADP101Active powder formulation.	Biological	High dose ADP101
Pooled PlaceboAlso: PlaceboPlacebo powder	Biological	Pooled Placebo

Primary outcome

600mg Desensitization in at Least One Qualifying Food
Time frame: 40 Weeks
The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.

3 secondary outcomes

1000mg Desensitization Threshold in Pediatric ITT Population
Time frame: 40 weeks
600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
Time frame: 40 weeks
1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
Time frame: 40 Weeks

Results and safety

Results posted to the registry on 16 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose ADP101	25	19
High Dose ADP101	24	16
Pooled Placebo	24	21

Primary outcome: 600mg Desensitization in at Least One Qualifying Food

Time frame: 40 Weeks. Count of participants. Unit: Participants

Measure	Low Dose ADP101 n = 21	High Dose ADP101 n = 20	Pooled Placebo n = 20
Value	8	11	4

Population analysed: The primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose ADP101, Pediatric Safety Population	0 of 21 (0%)	20 of 21 (95.2%)	0 of 21
High Dose ADP101, Pediatric Safety Population	1 of 20 (5%)	19 of 20 (95%)	0 of 20
Pooled PBO, Pediatric Safety Population	0 of 20 (0%)	19 of 20 (95%)	0 of 20
Low Dose ADP101, All-participants Safety Population	0 of 25 (0%)	24 of 25 (96%)	0 of 25
High Dose ADP101, All-participants Safety Population	1 of 24 (4.2%)	23 of 24 (95.8%)	0 of 24
Pooled PBO, All-participants Safety Population	0 of 24 (0%)	23 of 24 (95.8%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Food Allergy

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
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Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
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Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
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Recruiting
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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.

Mei-Lun Wang, MD study director

VP of Clinical Development, Alladapt Immunotherapeutics, Inc.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Low dose ADP101 and High dose ADP101 in people with Food Allergy, run by Alladapt Immunotherapeutics, Inc. at 15 sites in United States.

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 22 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

600mg Desensitization in at Least One Qualifying Food (time frame: 40 Weeks). 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 NCT04856865.

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 16 May 2024.