Phase
Condition
Atopic Dermatitis
Dermatitis, Atopic
Rosacea
Treatment
ADX-914
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years, inclusive, at time of informed consent, with chronic AD (duration ofdisease ≥3 years) diagnosed by the Eichenfield revised criteria of Hanifin andRajka.
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 atleast one of the following:
at least 4-week course of medium-potency topical steroids or other approvedtopical immunomodulators (calcineurin, PDE-4 and JAK inhibitors)
systemic steroids or phototherapy
oral chemical synthetic immunomodulators (MTX, mycophenolate mofetil,azathioprine, cyclosporine, systemic approved biologics [dupliumab, ustekinumabor tralokinumab]), or approved systemic targeted synthetic JAK inhibitors (upadacitinib, abrocitinib)
Exclusion
Exclusion Criteria:
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 ofrandomization
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 randomizationor 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 corticosteroidsor otherwise interfere with study participation or require active frequentmonitoring
Other concomitant skin conditions that would interfere with evaluations of theeffect of study medication on atopic dermatitis
Other active autoimmune diseases other than those above that would make it difficultto appropriately assess AD disease activity or pose a risk to the subject'sparticipation in the trial
Pregnant or lactating women, or women planning to become pregnant or initiatebreastfeeding.
History of sensitivity to any of the study treatments, or components thereof, or ahistory 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 theinvestigational agent (whichever is greater) prior to the informed consent.
Study Design
Study Description
Connect with a study center
Cahaba Dermatology Skin Health Center
Birmingham, Alabama 35244
United StatesSite Not Available
First OC Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
California Allergy and Asthma Medical Group- Los Angeles
Los Angeles, California 90025
United StatesSite Not Available
Integrative Skin Science and Research
Sacramento, California 95815
United StatesSite Not Available
Dermatology Institute and Skin Care Center
Santa Monica, California 90404
United StatesSite Not Available
Torrance Clinical Research Institute Inc.
Torrance, California 90505
United StatesSite Not Available
Integrated Research of Inland, Inc.
Upland, California 91786
United StatesSite Not Available
RM Medical Research Inc.
Homestead, Florida 33175
United StatesSite Not Available
Medical Research Center of Miami
Miami, Florida 33134
United StatesSite Not Available
Well Pharma Medical Research Corporation
Miami, Florida 33173
United StatesSite Not Available
Clinical Neurosciences Solutions Inc.
Orlando, Florida 32801
United StatesSite Not Available
GCP Research
Saint Petersburg, Florida 33705
United StatesSite Not Available
Alliance Clinical Research (Tampa)
Tampa, Florida 33615
United StatesSite Not Available
Avita Clinical Trials
Tampa, Florida 33613
United StatesSite Not Available
TruDerm
Wellington, Florida 33449
United StatesSite Not Available
Metabolic Research Institute Inc
West Palm Beach, Florida 33401
United StatesSite Not Available
Advanced Medical Research, PC
Sandy Springs, Georgia 30328
United StatesSite Not Available
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesSite Not Available
Sneeze wheeze and Itch Associates LLC
Normal, Illinois 61761
United StatesSite Not Available
Southern Indiana Clinical Trials
New Albany, Indiana 47150
United StatesSite Not Available
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168
United StatesSite Not Available
Randall Dermatology
West Lafayette, Indiana 47906
United StatesSite Not Available
Visage Clinical Research
Largo, Maryland 20774
United StatesSite Not Available
DermAssociates, PC.
Rockville, Maryland 20850
United StatesSite Not Available
Contemporary Dermatology
Marstons Mills, Massachusetts 02648
United StatesSite Not Available
Great Lakes Research Group
Bay City, Michigan 48706
United StatesSite Not Available
Revival Research Corporation- Clinedge
Troy, Michigan 48084
United StatesSite Not Available
Grekin Skin Institute
Warren, Michigan 48088
United StatesSite Not Available
Schweiger Dermatology Group
Hackensack, New Jersey 07601
United StatesSite Not Available
Optima Research
Boardman, Ohio 44512
United StatesSite Not Available
Apex Clinical Research Center
Painesville, Ohio 33612
United StatesSite Not Available
Central Sooner Research
Oklahoma City, Oklahoma 73170
United StatesSite Not Available
Clinical Partners, LLC
Johnston, Rhode Island 02919
United StatesSite Not Available
North Texas Center for Clinical Research
Frisco, Texas 75034
United StatesSite Not Available
Clinical Trial Network
Houston, Texas 77074
United StatesSite Not Available
Progressive Clinical Research
San Antonio, Texas 78213
United StatesSite Not Available
JBR Clinical Research
Salt Lake City, Utah 84107
United StatesSite Not Available
Advanced Research Institute- South Ogden
South Ogden, Utah 84405
United StatesSite Not Available
Dermatology of Seattle & Bellevue
Seattle, Washington 98004
United StatesSite Not Available
Dermatology Specialists of Spokane
Spokane, Washington 99202
United StatesSite Not Available
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