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ADX-914 for Atopic Dermatitis

Phase 2
Recruiting
Research Sponsored by Q32 Bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years, inclusive, at time of informed consent, with chronic AD (duration of disease ≥3 years) diagnosed by the Eichenfield revised criteria of Hanifin and Rajka
Moderate to severe disease activity at baseline and screening defined as: BSA affected ≥10%, EASI Score ≥12, Investigators Global Score (IGA) ≥3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial tests a new drug to treat Atopic Dermatitis in people with moderate-severe symptoms.

Who is the study for?
Adults over 18 with chronic Atopic Dermatitis for at least 3 years, showing moderate to severe symptoms despite previous treatments. Excluded are those with recent serious infections, other skin conditions, participation in another trial within the last month or so, exposure to live vaccines recently or during the study, TB history, pregnant or breastfeeding women, known allergies to study treatments and those with certain autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing ADX-914 against a placebo in adults with moderate to severe Atopic Dermatitis. It's a phase IIa study where participants don't know if they're getting the real medicine or a dummy pill (double-blind), and neither do the doctors (placebo-controlled).See study design
What are the potential side effects?
While specific side effects of ADX-914 aren't listed here, common side effects for dermatitis treatments include skin irritation or burning sensation at application site, itching, redness and possible infection due to weakened skin barrier.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and have had chronic AD for 3+ years, diagnosed by a specific criteria.
Select...
My skin condition affects more than 10% of my body and is moderate to severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
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
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ADX-914Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADX-914
2020
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Q32 Bio Inc.Lead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled

Media Library

ADX-914 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05509023 — Phase 2
Atopic Dermatitis Research Study Groups: Placebo, ADX-914
Atopic Dermatitis Clinical Trial 2023: ADX-914 Highlights & Side Effects. Trial Name: NCT05509023 — Phase 2
ADX-914 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509023 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study currently enrolling participants?

"Clinicaltrials.gov records indicate that this medical study is still seeking participants, with the initial post published on September 30th 2022 and last updated November 10th 2022."

Answered by AI

Are there numerous centers in Canada currently conducting this clinical experiment?

"Participants interested in this trial can be enrolled at Clinical Neurosciences Solutions Inc. located in Orlando, Florida, Randall Dermatology in West Lafayette, Indiana, and Revival Research Corporation- Clinedge which is situated in Troy Michigan as well as 8 other clinical settings across the nation."

Answered by AI

How many test subjects are engaged in the ongoing experiment?

"Q32 Bio Inc. is sponsoring a clinical trial requiring 110 eligible patients across various sites, including Clinical Neurosciences Solutions in Orlando and Randall Dermatology in West Lafayette."

Answered by AI

What is the objective of this scientific trial?

"Per data provided by the study sponsor, Q32 Bio Inc., the primary outcome to be measured over a 14 Week period is Part A and B: The Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 vs placebo. In addition to this investigation, secondary outcomes such as Mean % Change from Baseline in Scoring Atopic dermatitis (SCORAD) Score with minimum 0% (least severe) & maximum 100% (most severe), Proportion of participants experiencing an Eczema Area & Severity Index reduction of 50%,"

Answered by AI

Has ADX-914 been granted authorization by the Food and Drug Administration?

"Taking into account the nature of this Phase 2 trial, ADX-914's safety is rated as a 2 on our team's scale. While there are some findings that suggest its security, no data has been collected to support its effectiveness."

Answered by AI

Who else is applying?

What site did they apply to?
Schweiger Dermatology Group
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)
2022. "Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05509023.
All > Seborrheic Dermatitis > Atopic Dermatitis
~27 spots leftby Dec 2024
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