A Study to Evaluate the Safety and Effectiveness of ADX-914 in Subjects with Moderate to Severe Atopic Dermatitis
- Conditions
- Moderate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code: 10003639Term: Atopic dermatitis Class: 10040785Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-510238-10-00
- Lead Sponsor
- Q32 Bio Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 102
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: a. BSA affected =10% b. EASI Score =12 c. 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: a. at least 4 week course of medium-potency topical steroids or other approved topical immunomodulators (calcineurin, PDE-4 and JAK inhibitors) b. systemic steroids or phototherapy c. oral chemical synthetic immunomodulators (methotrexate [MTX], mycophenolate mofetil, azathioprine, cyclosporine, systemic approved biologics [dupilumab, ustekinumab or tralokinumab]), or approved systemic targeted synthetic JAK inhibitors (upadacitinib, abrocitinib)
1. Body weight = 50.0 kg for men and = 45.0 kg for women and > 120 kg at Screening, 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., 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 or immunotherapy required for any other condition, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Part A only: To identify the recommended ADX-914 dose for Part B<br>Part B only: To evaluate the efficacy of ADX-914 vs placebo;Secondary Objective: Part B only: To evaluate the efficacy of ADX-914 (Part B dose selected) vs placebo, Part A and B: To evaluate the safety and tolerability of ADX-914 compared with placebo in subjects with atopic dermatitis (AD) during the treatment period and follow-up;Primary end point(s): Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest, Part B only: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 (Part B dose selected) vs placebo
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Mean percentage change from baseline in EASI score at Weeks 4, 8, 12, 16, and 24;Secondary end point(s):Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score at Weeks 4, 8, 12, 14, 16, and 24;Secondary end point(s):Proportion of subjects achieving EASI 50, 75 and 90 at Weeks 4, 8, 12, 14, 16, and 24;Secondary end point(s):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 at Weeks 4, 8, 12, 14, 16, and 24;Secondary end point(s):Part A and B: Safety of ADX-914 in the AD population as evaluated by adverse events (AEs), laboratory evaluations, physical examinations, vital signs, and 12-lead electrocardiogram (ECG)