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

NCT ID: NCT05509023

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ADX-914

Group Type: EXPERIMENTAL

ADX-914

Intervention Type: DRUG

Subcutaneous administration of ADX-914

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous administration of Placebo

Interventions

ADX-914

Subcutaneous administration of ADX-914

Intervention Type: DRUG

Placebo

Subcutaneous administration of Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Q32 Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

ADX-914-202

Identifier Type: -

Identifier Source: org_study_id