NCT05509023

Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Proof-of-Concept Study Evaluating the Safety and Efficacy of ADX-914 in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Q32 Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in subjects with moderate to severe Atopic Dermatitis.

Detailed description

This is a two-part phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in adult subjects with persistent moderate to severe Atopic Dermatitis (AD). ADX-914 or matching placebo for administered subcutaneously in the clinic setting every 2 weeks for 12 weeks, and follow-up for 12 weeks. ADX-914 or matching placebo will be in the clinic setting post-randomization. In Part A, up to 3 cohorts of subjects will be randomized 2:1 drug vs placebo. In Part B subjects will be randomized 1:1 to drug vs placebo at a doses selected in Part A.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ADX-914	Subcutaneous administration of ADX-914
DRUG	Placebo	Subcutaneous administration of Placebo

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-08-19
• Last updated: 2024-10-03

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study