Open-label Extension Study of ADP101

Alladapt Immunotherapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Food Allergy

Treatments: Biological: ADP101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05243719

ADP101-MA-02

Details and patient eligibility

About

This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).

Full 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).

Enrollment: 45 patients

Sex: All

Ages: 4 to 57 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Treatment Options 1, 2, 3, 4, 5

Experimental group

Description:

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.

Treatment:

Biological: ADP101