NCT05440643|Active Not RecruitingPhase 1FDA Drug

Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy

A Phase I/II Trial in 3 Parts Assessing the Safety, Tolerability, and Efficacy of a Once-daily Peanut Sublingual Immunotherapy (SLIT) Tablet in Adults, Adolescents, and Children With Peanut Allergy

ALK-Abelló A/S ClinicalTrials.gov

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1 other identifier

PT-01

Study Type

interventional

Target

192

Locations

2 countries

Sites

Timeline

RegisteredJul 2022

StartedSep 2022

CompletionApr 2026

Brief Summary

This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

192

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Sep 2022

Typical duration for phase_1

Geographic Reach

2 countries

42 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.6 years study duration

First Submitted

Initial submission to the registry

June 17, 2022

Completed

14 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed

22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed

Last Updated

March 18, 2026

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

June 17, 2022

Last Update Submit

March 17, 2026

Conditions

Peanut Allergy

Keywords

Peanut allergyChildrenAdolescentAdult

Outcome Measures

Primary Outcomes (2)

Part 1 and 2: Dose tolerability response rate
The dose tolerability response rate is defined as the percentage of subjects who experience at most moderate local application site reactions after the last peanut SLIT-tablet intake of the dose step. Local application site reactions are treatment-related adverse events occurring in close proximity to the application site of the SLIT-tablet with a temporal relationship to tablet administration.
2 weeks per dose
Part 3: TD-600 response rate
The TD (tolerated dose)-600 response rate is defined as the percentage of subjects able to consume 600 mg (1044 mg cumulative) peanut protein without dose-limiting symptoms at the exit double-blind placebo-controlled food challenge (DBPCFC) after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.
After 24 weeks of maintenance treatment, up to 48 weeks.

Secondary Outcomes (7)

Part 1, 2 and 3: Treatment-emergent adverse events
Part 1 and 2: 2 weeks per dose; Part 3: from first IMP intake to 7 days after last IMP intake, up to 48 weeks.
Part 3: TD-300 response rate
After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: TD-1000 response rate
After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: TD-2000 response rate
After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: Maximum tolerated dose of peanut protein during DBPCFC
At screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks.
+2 more secondary outcomes