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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT05509023

Run by

Q32 Bio Inc.

People needed

102

Starts

2022-09-30

Expected to finish

2024-12-01

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Who, in the opinion of the Investigator, have a history of inadequate response to at least one of the following:
• at least 4-week course of medium-potency topical steroids or other approved topical immunomodulators (calcineurin, PDE-4 and JAK inhibitors)
• systemic steroids or phototherapy
• 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)

You may not qualify if…

• Body weight ≤ 50.0 kg for men and ≤ 45.0 kg for women and > 120 kg at Screening
• Rescue therapy, topical or systemic, need anticipated within 4 weeks of randomization
• Recent (within 2 months of informed consent) or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection
• A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)
• 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
• Systemic, topical or device-based therapy of AD
• Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring
• Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on atopic dermatitis
• 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
• Pregnant or lactating women, or women planning to become pregnant or initiate breastfeeding.
• 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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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