Food AllergyPhase 1/2NCT05243719
Open-label Extension Study of ADP101
A Phase 1/2 study testing ADP101 in people with Food Allergy, run by Alladapt Immunotherapeutics, Inc. at 14 sites in United States.
Trial summary
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01). Read more about this study
- Who is it for?
- Ages 4 to 57 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- ADP101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 14 sitesUnited States
- Study dates
- 14 Mar 2022to 27 Feb 2024
- Phase
- Phase 1/2
- 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 57 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol
Who cannot join
- History of or current EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
- Hypersensitivity to epinephrine or any of the excipients in ADP101
- Prior or 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
Show all 10Show fewer
- any food immunotherapy currently or within the previous 12 weeks, except ADP101
- investigational agents other than ADP101
- in the build up phase of non-food immunotherapy
- Any other condition that might preclude safe participation in the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 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
Colorado Springs, Colorado, 80907
Study Site
Denver, Colorado, 80230
Study Site
Marietta, Georgia, 30060
Study Site
Mission Viejo, California, 92691
Study Site
Normal, Illinois, 61761
Study Site
Rolling Hills Estates, California, 90274
Study Site
San Diego, California, 92123
Study Site
Seattle, Washington, 98115
Study Site
Tampa, Florida, 33620
About this study
Official title: An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study)
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
Read the detailed description
This study is enrolling participants by invitation only. This is a multicenter, open-label, long-term extension study of the safety and efficacy of ADP101 for oral immunotherapy in food allergic children and adults who completed the Harmony study (protocol ADP101-MA-01).
- Conditions
- Food Allergy
- Being tested
- ADP101
- 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.
ADP101Biological
Active dry powder formulation at various volumes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Options 1, 2, 3, 4, 5 | Experimental | Participants will fall into 1 of 5 treatment options dependent on the treatment received (ADP101 or placebo) during the parent study and their tolerance of the treatment regimen during the parent study. Receives: Biological: ADP101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety and tolerability of ADP101
Incidence of adverse events including serious adverse events during the study period.
Measured: Through study completion, approximately 4-6 years
Secondary outcomes (1)
Food Allergy Desensitization
The proportion of subjects who tolerate a highest dose of at least 600-mg level of protein from a relevant allergen or allergens without dose-limiting symptoms at the Week 40 double-blind placebo-controlled food challenge.
Measured: Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start14 Mar 2022
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alladapt Immunotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mei-Lun Wang, MD, Study director, VP of Clinical Development, Alladapt Immunotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243719
- Sponsor's protocol ID
- ADP101-MA-02
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study)
- ClinicalTrials.gov ID
- NCT05243719
- Acronym / sponsor ID
- ADP101-MA-02
- 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
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Alladapt Immunotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 17 Feb 2022 (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 is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
Detailed description
This study is enrolling participants by invitation only. This is a multicenter, open-label, long-term extension study of the safety and efficacy of ADP101 for oral immunotherapy in food allergic children and adults who completed the Harmony study (protocol ADP101-MA-01).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Options 1, 2, 3, 4, 5 | Experimental | Biological: ADP101Participants will fall into 1 of 5 treatment options dependent on the treatment received (ADP101 or placebo) during the parent study and their tolerance of the treatment regimen during the parent study. |
Who may qualify
- Ages
- 4 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol
Key exclusion criteria (10 listed)
- History of or current EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
- Hypersensitivity to epinephrine or any of the excipients in ADP101
- Prior or concurrent therapies as follows:
- Any other condition that might preclude safe participation in the study
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 |
|---|---|---|
| ADP101Active dry powder formulation at various volumes. | Biological | Treatment Options 1, 2, 3, 4, 5 |
Primary outcome
Long-term safety and tolerability of ADP101
Time frame: Through study completion, approximately 4-6 years
Incidence of adverse events including serious adverse events during the study period.
1 secondary outcome
Food Allergy Desensitization
Time frame: Week 40
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Food Allergy
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Slow Multiallergen Oral Immunotherapy in Young Children
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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.
14 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 ADP101 in people with Food Allergy, run by Alladapt Immunotherapeutics, Inc. at 14 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 1 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Long-term safety and tolerability of ADP101 (time frame: Through study completion, approximately 4-6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2024.