Open-label Extension Study of ADP101

Phase 1

Terminated

• Conditions: Food Allergy
• Interventions: Biological: ADP101

• Registration Number: NCT05243719
• Lead Sponsor: Alladapt Immunotherapeutics, Inc.

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).

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-17
• Study Start: 2022-03-14
• Primary Completion: 2024-02-27
• Study Completion: 2024-02-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Options 1, 2, 3, 4, 5	ADP101	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.

Primary Outcome Measures

Name	Time	Method
Long-term safety and tolerability of ADP101	Through study completion, approximately 4-6 years	Incidence of adverse events including serious adverse events during the study period.

Secondary Outcome Measures

Name	Time	Method
Food Allergy Desensitization	Week 40	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.

Trial Locations

Locations (1)

Study Site; 🇺🇸 Seattle, Washington, United States