ADX-914 for Atopic Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Atopic DermatitisADX-914 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 24 Weeks

14 Weeks
Part A and B: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 vs placebo
Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest
24 Weeks
Incidence of adverse events
Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score
Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score
Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90%
Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with at least 2 grades of reduction from Baseline

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

ADX-914
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

110 Total Participants · 2 Treatment Groups

Primary Treatment: ADX-914 · Has Placebo Group · Phase 2

ADX-914
Drug
Experimental Group · 1 Intervention: ADX-914 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADX-914
2020
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Q32 Bio Inc.Lead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have EASI Score ≥12.