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

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Proof-of-Concept Study Evaluating the Safety and Efficacy of ADX-914 in Subjects With Moderate to Severe Atopic Dermatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: ADX-914

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kristin Orr; Phone Number: 9193950132; Email: korr@q32bio.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Recruiting
      • Cahaba Dermatology Skin Health Center
  • California
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • First Oc Dermatology
    • Los Angeles, California, United States, 90025
      • Recruiting
      • California Allergy and Asthma Medical Group- Los Angeles
    • Sacramento, California, United States, 95815
      • Not yet recruiting
      • Integrative Skin Science and Research
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Dermatology Institute and Skin Care Center
    • Torrance, California, United States, 90505
      • Not yet recruiting
      • Torrance Clinical Research Institute Inc.
    • Upland, California, United States, 91786
      • Not yet recruiting
      • Integrated Research of Inland, Inc.
  • Florida
    • Homestead, Florida, United States, 33175
      • Recruiting
      • RM Medical Research Inc.
    • Miami, Florida, United States, 33134
      • Recruiting
      • Medical Research Center of Miami
    • Miami, Florida, United States, 33173
      • Recruiting
      • Well Pharma Medical Research Corporation
    • Orlando, Florida, United States, 32801
      • Withdrawn
      • Clinical Neurosciences Solutions Inc.
    • Saint Petersburg, Florida, United States, 33705
      • Recruiting
      • GCP Research
    • Tampa, Florida, United States, 33613
      • Withdrawn
      • Avita Clinical Trials
    • Tampa, Florida, United States, 33615
      • Withdrawn
      • Alliance Clinical Research (Tampa)
    • Wellington, Florida, United States, 33449
      • Withdrawn
      • TruDerm
    • West Palm Beach, Florida, United States, 33401
      • Withdrawn
      • Metabolic Research Institute Inc
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Recruiting
      • Advanced Medical Research, PC
  • Idaho
    • Boise, Idaho, United States, 83706
      • Not yet recruiting
      • Treasure Valley Medical Research
  • Illinois
    • Normal, Illinois, United States, 61761
      • Recruiting
      • Sneeze Wheeze and Itch Associates Llc
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Not yet recruiting
      • Southern Indiana Clinical Trials
    • Plainfield, Indiana, United States, 46168
      • Withdrawn
      • The Indiana Clinical Trials Center, PC
    • West Lafayette, Indiana, United States, 47906
      • Withdrawn
      • Randall Dermatology
  • Maryland
    • Largo, Maryland, United States, 20774
      • Not yet recruiting
      • Visage Clinical Research
    • Rockville, Maryland, United States, 20850
      • Withdrawn
      • DermAssociates, PC.
  • Massachusetts
    • Marstons Mills, Massachusetts, United States, 02648
      • Withdrawn
      • Contemporary Dermatology
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Withdrawn
      • Great Lakes Research Group
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Revival Research Corporation- Clinedge
    • Warren, Michigan, United States, 48088
      • Withdrawn
      • Grekin Skin Institute
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Withdrawn
      • Schweiger Dermatology Group
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Withdrawn
      • Optima Research
    • Painesville, Ohio, United States, 33612
      • Not yet recruiting
      • Apex Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73170
      • Withdrawn
      • Central Sooner Research
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Recruiting
      • Clinical Partners, LLC
  • Texas
    • Frisco, Texas, United States, 75034
      • Recruiting
      • North Texas Center for Clinical Research
    • Houston, Texas, United States, 77074
      • Withdrawn
      • Clinical Trial Network
    • San Antonio, Texas, United States, 78213
      • Recruiting
      • Progressive Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Not yet recruiting
      • JBR Clinical Research
    • South Ogden, Utah, United States, 84405
      • Withdrawn
      • Advanced Research Institute- South Ogden
  • Washington
    • Seattle, Washington, United States, 98004
      • Recruiting
      • Dermatology of Seattle & Bellevue
    • Spokane, Washington, United States, 99202
      • Recruiting
      • Dermatology Specialists of Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Subcutaneous administration of Placebo
Experimental: ADX-914	Drug: ADX-914; Subcutaneous administration of ADX-914

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest		14 Weeks
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	Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (less severe) and maximum score is 72 (most severe).	14 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score	Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (least severe) and maximum score is 72 (most severe)	24 Weeks
Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score	Score is based on evaluation of 6 body regions (Head and neck, upper limbs, lower limbs, anterior trunk, back, and genitals). The minimum score is 0% (least severe) and the maximum score is 100% (most severe)	24 Weeks
Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90%	Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (least severe) and maximum score is 72 (most severe)	24 Weeks
Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with at least 2 grades of reduction from Baseline	Score is based on Investigator's impresion of the severity of Atopic Dermatitis with 0 being the least severe and 4 being the most severe	24 Weeks
Incidence of adverse events	As evaluated by vital signs, physical examinations, laboratory evaluations, and 12-lead electrocardiograms	24 Weeks

Collaborators and Investigators

• Sponsor: Q32 Bio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Eczema Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ADX-914-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No