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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
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510238-10-00
Acronym
ADX-914-202
Enrollment
18
Registered
2024-04-29
Start date
2024-05-13
Completion date
2024-12-10
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Atopic Dermatitis

Brief summary

Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest, Part B only: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 (Part B dose selected) vs placebo

Detailed description

Mean percentage change from baseline in EASI score at Weeks 4, 8, 12, 16, and 24, Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score at Weeks 4, 8, 12, 14, 16, and 24, Proportion of subjects achieving EASI 50, 75 and 90 at Weeks 4, 8, 12, 14, 16, and 24, 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 at Weeks 4, 8, 12, 14, 16, and 24, Part A and B: Safety of ADX-914 in the AD population as evaluated by adverse events (AEs), laboratory evaluations, physical examinations, vital signs, and 12-lead electrocardiogram (ECG)

Interventions

DRUGPlacebo

Sponsors

Q32 Bio Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest, Part B only: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 (Part B dose selected) vs placebo

Secondary

MeasureTime frame
Mean percentage change from baseline in EASI score at Weeks 4, 8, 12, 16, and 24, Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score at Weeks 4, 8, 12, 14, 16, and 24, Proportion of subjects achieving EASI 50, 75 and 90 at Weeks 4, 8, 12, 14, 16, and 24, 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 at Weeks 4, 8, 12, 14, 16, and 24, Part A and B: Safety of ADX-914 in the AD population as evaluated by adverse events (AEs), laboratory evaluations, physical examinations, vital signs, and 12-lead electrocardiogram (ECG)

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026