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

Phase 2

Active, not recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: ADX-914

• Registration Number: NCT05509023
• Lead Sponsor: Q32 Bio Inc.

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.

Study Timeline

• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Study Start: 2022-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ADX-914	ADX-914	-

Primary Outcome Measures

Name	Time	Method
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	14 Weeks	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).

Secondary Outcome Measures

Name	Time	Method
Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score	24 Weeks	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)
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	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
Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score	24 Weeks	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)
Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90%	24 Weeks	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)
Incidence of adverse events	24 Weeks	As evaluated by vital signs, physical examinations, laboratory evaluations, and 12-lead electrocardiograms

Trial Locations

Locations (24)

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

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; 🇺🇸 Saint 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