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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05509023
Other study ID # ADX-914-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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