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

NCT05509023 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ADX-914-202
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Eczema Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score

  24 Weeks

• Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score

  24 Weeks

• Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90%

  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

  24 Weeks

• Incidence of adverse events

  24 Weeks

Study Arms (2)

ADX-914

EXPERIMENTAL

Drug: ADX-914

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ADX-914 DRUG

Subcutaneous administration of ADX-914

ADX-914

Placebo DRUG

Subcutaneous administration of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Q32 Bio Inc.: lead

Study Sites (24)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, 35244, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

California Allergy and Asthma Medical Group- Los Angeles

Los Angeles, California, 90025, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Dermatology Institute and Skin Care Center

Santa Monica, California, 90404, United States

Location

Torrance Clinical Research Institute Inc.

Torrance, California, 90505, United States

Location

Integrated Research of Inland, Inc.

Upland, California, 91786, United States

Location

RM Medical Research Inc.

Homestead, Florida, 33175, United States

Location

Medical Research Center of Miami

Miami, Florida, 33134, United States

Location

Well Pharma Medical Research Corporation

Miami, Florida, 33173, United States

Location

GCP Research

St. Petersburg, Florida, 33705, United States

Location

Advanced Medical Research, PC

Sandy Springs, Georgia, 30328, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Sneeze wheeze and Itch Associates LLC

Normal, Illinois, 61761, United States

Location

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

Location

Visage Clinical Research

Largo, Maryland, 20774, United States

Location

Revival Research Corporation- Clinedge

Troy, Michigan, 48084, United States

Location

Apex Clinical Research Center

Painesville, Ohio, 33612, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

North Texas Center for Clinical Research

Frisco, Texas, 75034, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Dermatology of Seattle & Bellevue

Seattle, Washington, 98004, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 19, 2022
• Study Start: September 30, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)