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

Last updated: October 1, 2024
Sponsor: Q32 Bio Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Atopic Dermatitis

Dermatitis, Atopic

Rosacea

Treatment

ADX-914

Placebo

Clinical Study ID

NCT05509023
ADX-914-202
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. Moderate to severe disease activity at baseline and screening defined as:

  3. BSA affected ≥10%

  4. EASI Score ≥12

  5. Investigators Global Score (IGA) ≥3

  6. Who, in the opinion of the Investigator, have a history of inadequate response to atleast one of the following:

  7. at least 4-week course of medium-potency topical steroids or other approvedtopical immunomodulators (calcineurin, PDE-4 and JAK inhibitors)

  8. systemic steroids or phototherapy

  9. 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:

  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 ofrandomization

  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 randomizationor 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 corticosteroidsor otherwise interfere with study participation or require active frequentmonitoring

  8. Other concomitant skin conditions that would interfere with evaluations of theeffect of study medication on atopic dermatitis

  9. 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

  10. Pregnant or lactating women, or women planning to become pregnant or initiatebreastfeeding.

  11. 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.

  12. 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

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: ADX-914
Phase: 2
Study Start date:
September 30, 2022
Estimated Completion Date:
December 31, 2024

Study Description

This is a two-part phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in adult subjects with persistent moderate to severe Atopic Dermatitis (AD). ADX-914 or matching placebo for administered subcutaneously in the clinic setting every 2 weeks for 12 weeks, and follow-up for 12 weeks. ADX-914 or matching placebo will be in the clinic setting post-randomization. In Part A, up to 3 cohorts of subjects will be randomized 2:1 drug vs placebo. In Part B subjects will be randomized 1:1 to drug vs placebo at a doses selected in Part A.

Connect with a study center

  • Cahaba Dermatology Skin Health Center

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • California Allergy and Asthma Medical Group- Los Angeles

    Los Angeles, California 90025
    United States

    Site Not Available

  • Integrative Skin Science and Research

    Sacramento, California 95815
    United States

    Site Not Available

  • Dermatology Institute and Skin Care Center

    Santa Monica, California 90404
    United States

    Site Not Available

  • Torrance Clinical Research Institute Inc.

    Torrance, California 90505
    United States

    Site Not Available

  • Integrated Research of Inland, Inc.

    Upland, California 91786
    United States

    Site Not Available

  • RM Medical Research Inc.

    Homestead, Florida 33175
    United States

    Site Not Available

  • Medical Research Center of Miami

    Miami, Florida 33134
    United States

    Site Not Available

  • Well Pharma Medical Research Corporation

    Miami, Florida 33173
    United States

    Site Not Available

  • Clinical Neurosciences Solutions Inc.

    Orlando, Florida 32801
    United States

    Site Not Available

  • GCP Research

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Alliance Clinical Research (Tampa)

    Tampa, Florida 33615
    United States

    Site Not Available

  • Avita Clinical Trials

    Tampa, Florida 33613
    United States

    Site Not Available

  • TruDerm

    Wellington, Florida 33449
    United States

    Site Not Available

  • Metabolic Research Institute Inc

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Advanced Medical Research, PC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Site Not Available

  • Sneeze wheeze and Itch Associates LLC

    Normal, Illinois 61761
    United States

    Site Not Available

  • Southern Indiana Clinical Trials

    New Albany, Indiana 47150
    United States

    Site Not Available

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Randall Dermatology

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Visage Clinical Research

    Largo, Maryland 20774
    United States

    Site Not Available

  • DermAssociates, PC.

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Contemporary Dermatology

    Marstons Mills, Massachusetts 02648
    United States

    Site Not Available

  • Great Lakes Research Group

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Revival Research Corporation- Clinedge

    Troy, Michigan 48084
    United States

    Site Not Available

  • Grekin Skin Institute

    Warren, Michigan 48088
    United States

    Site Not Available

  • Schweiger Dermatology Group

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Optima Research

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Apex Clinical Research Center

    Painesville, Ohio 33612
    United States

    Site Not Available

  • Central Sooner Research

    Oklahoma City, Oklahoma 73170
    United States

    Site Not Available

  • Clinical Partners, LLC

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • North Texas Center for Clinical Research

    Frisco, Texas 75034
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • JBR Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Advanced Research Institute- South Ogden

    South Ogden, Utah 84405
    United States

    Site Not Available

  • Dermatology of Seattle & Bellevue

    Seattle, Washington 98004
    United States

    Site Not Available

  • Dermatology Specialists of Spokane

    Spokane, Washington 99202
    United States

    Site Not Available

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