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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509023
• Other study ID #: ADX-914-202
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Q32 Bio Inc.
• Contact: Kristin Orr
• Phone: 9193950132
• Email: korr[@]q32bio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ADX-914
Subcutaneous administration of ADX-914
• Placebo
Subcutaneous administration of Placebo

Locations

Country	Name	City	State
United States	Great Lakes Research Group	Bay City	Michigan
United States	Cahaba Dermatology Skin Health Center	Birmingham	Alabama
United States	Optima Research	Boardman	Ohio
United States	Treasure Valley Medical Research	Boise	Idaho
United States	First OC Dermatology	Fountain Valley	California
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	Schweiger Dermatology Group	Hackensack	New Jersey
United States	RM Medical Research Inc.	Homestead	Florida
United States	Clinical Trial Network	Houston	Texas
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Visage Clinical Research	Largo	Maryland
United States	California Allergy and Asthma Medical Group- Los Angeles	Los Angeles	California
United States	Contemporary Dermatology	Marstons Mills	Massachusetts
United States	Medical Research Center of Miami	Miami	Florida
United States	Well Pharma Medical Research Corporation	Miami	Florida
United States	Southern Indiana Clinical Trials	New Albany	Indiana
United States	Sneeze wheeze and Itch Associates LLC	Normal	Illinois
United States	Central Sooner Research	Oklahoma City	Oklahoma
United States	Clinical Neurosciences Solutions Inc.	Orlando	Florida
United States	Apex Clinical Research Center	Painesville	Ohio
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	DermAssociates, PC.	Rockville	Maryland
United States	Integrative Skin Science and Research	Sacramento	California
United States	GCP Research	Saint Petersburg	Florida
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Progressive Clinical Research	San Antonio	Texas
United States	Advanced Medical Research, PC	Sandy Springs	Georgia
United States	Dermatology Institute and Skin Care Center	Santa Monica	California
United States	Dermatology of Seattle & Bellevue	Seattle	Washington
United States	Advanced Research Institute- South Ogden	South Ogden	Utah
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	Alliance Clinical Research (Tampa)	Tampa	Florida
United States	Avita Clinical Trials	Tampa	Florida
United States	Torrance Clinical Research Institute Inc.	Torrance	California
United States	Revival Research Corporation- Clinedge	Troy	Michigan
United States	Integrated Research of Inland, Inc.	Upland	California
United States	Grekin Skin Institute	Warren	Michigan
United States	TruDerm	Wellington	Florida
United States	Randall Dermatology	West Lafayette	Indiana
United States	Metabolic Research Institute Inc	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Q32 Bio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest		14 Weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of adverse events	As evaluated by vital signs, physical examinations, laboratory evaluations, and 12-lead electrocardiograms	24 Weeks