Clinical trial NCT05243719: Open-label Extension Study of ADP101
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Food Allergy
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
Dairy allergy
Desensitization
Food hypersensitivity
Immune system disease
Hypersensitivity, immediate
Hypersensitivity
Lead sponsor: Alladapt Immunotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 57
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: Key Inclusion Criteria:

• Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol

Key Exclusion Criteria:

* 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
  * 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

Primary outcomes:
measure: Long-term safety and tolerability of ADP101
timeFrame: Through study completion, approximately 4-6 years
Secondary outcomes:
measure: Food Allergy Desensitization
timeFrame: Week 40
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Study Site
state: California
city: Rolling Hills Estates
country: United States
facility: Study Site
state: California
city: San Diego
country: United States
facility: Study Site
state: California
city: Colorado Springs
country: United States
facility: Study Site
state: Colorado
city: Denver
country: United States
facility: Study Site
state: Colorado
city: Tampa
country: United States
facility: Study Site
state: Florida
city: Atlanta
country: United States
facility: Study Site
state: Georgia
city: Marietta
country: United States
facility: Study Site
state: Georgia
city: Normal
country: United States
facility: Study Site
state: Illinois
city: Ann Arbor
country: United States
facility: Study Site
state: Michigan
city: Chapel Hill
country: United States
facility: Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Study Site
state: Ohio
city: Charleston
country: United States
facility: Study Site
state: South Carolina
city: Seattle
country: United States
facility: Study Site
state: Washington
Study officials:
affiliation: VP of Clinical Development, Alladapt Immunotherapeutics, Inc.
name: Mei-Lun Wang, MD
role: STUDY_DIRECTOR
References: