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Clinical Trials in the USA / NCT05509023
Active, not recruiting Phase 2

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

NCT05509023 · tracked via the Priya Life Science USA tracker
Sponsor
Q32 Bio Inc.
Phase
Phase 2
Started
2022-09-30
Last updated
2024-10-03

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

ADX-914 →Placebo

ADX-914: Subcutaneous administration of ADX-914

Placebo: Subcutaneous administration of Placebo

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Moderate to severe disease activity at baseline and screening defined as: 1. BSA affected ≥10% 2. EASI Score ≥12 3. Investigators Global Score (IGA) ≥3 3. Who, in the opinion of the Investigator, have a history of inadequate response to at least one of the following: 1. at least 4-week course of medium-potency topical steroids or other approved topical immunomodulators (calcineurin, PDE-4 and JAK inhibitors) 2. systemic steroids or phototherapy 3. oral chemical synthetic immunomodulators (MTX, mycophenolate mofetil, azathioprine, cyclosporine, systemic approved biologics \[dupliumab, ustekinumab or tralokinumab\]), or approved systemic targeted synthetic JAK inhibitors (upadacitinib, abrocitinib) Exclusion Criteria: 1. Body weight ≤ 50.0 kg for men and ≤ 45.0 kg for women and \> 120 kg at Screening 2. Rescue therapy, topical or systemic, need anticipated within 4 weeks of randomization 3. Recent (within 2 months of informed consent) or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection 4. A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB) 5. Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to receive a live vaccine during the study 6. Systemic, topical or device-based therapy of AD 7. Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring 8. Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on atopic dermatitis 9. Other active autoimmune diseases other than those above that would make it difficult to appropriately assess AD disease activity or pose a risk to the subject's participation in the trial 10. Pregnant or lactating women, or women planning to become pregnant or initiate breastfeeding. 11. History of sensitivity to any of the study treatments, or components thereof, or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates their participation. 12. Has been in another investigational trial within 30 days or 5 half-lives of the investigational agent (whichever is greater) prior to the informed consent.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Cahaba Dermatology Skin Health Center Birmingham Alabama
First OC Dermatology Fountain Valley California
California Allergy and Asthma Medical Group- Los Angeles Los Angeles California
Integrative Skin Science and Research Sacramento California
Dermatology Institute and Skin Care Center Santa Monica California
Torrance Clinical Research Institute Inc. Torrance California
Integrated Research of Inland, Inc. Upland California
RM Medical Research Inc. Homestead Florida
Medical Research Center of Miami Miami Florida
Well Pharma Medical Research Corporation Miami Florida
GCP Research St. Petersburg Florida
Advanced Medical Research, PC Sandy Springs Georgia
Treasure Valley Medical Research Boise Idaho
Sneeze wheeze and Itch Associates LLC Normal Illinois
Southern Indiana Clinical Trials New Albany Indiana
Visage Clinical Research Largo Maryland
Revival Research Corporation- Clinedge Troy Michigan
Apex Clinical Research Center Painesville Ohio
Clinical Partners, LLC Johnston Rhode Island
North Texas Center for Clinical Research Frisco Texas
Progressive Clinical Research San Antonio Texas
JBR Clinical Research Salt Lake City Utah
Dermatology of Seattle & Bellevue Seattle Washington
Dermatology Specialists of Spokane Spokane Washington

More Q32 Bio Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05509023 on ClinicalTrials.gov ↗ ← All trials in the USA