Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ADX-914
|
Drug: ADX-914
Subcutaneous administration of ADX-914
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Subcutaneous administration of Placebo
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
- 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)
- 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
- Incidence of adverse events [24 Weeks]
As evaluated by vital signs, physical examinations, laboratory evaluations, and 12-lead electrocardiograms
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
Moderate to severe disease activity at baseline and screening defined as:
-
BSA affected ≥10%
-
EASI Score ≥12
-
Investigators Global Score (IGA) ≥3
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Who, in the opinion of the Investigator, have a history of inadequate response to at least one of the following:
-
at least 4-week course of medium-potency topical steroids or other approved topical immunomodulators (calcineurin, PDE-4 and JAK inhibitors)
-
systemic steroids or phototherapy
-
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:
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Body weight ≤ 50.0 kg for men and ≤ 45.0 kg for women and > 100 kg at Screening
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Rescue therapy, topical or systemic, need anticipated within 4 weeks of randomization
-
Recent (within 2 months of informed consent) or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection
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A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)
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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
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Systemic, topical or device-based therapy of AD
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Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring
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Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on atopic dermatitis
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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
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Pregnant or lactating women, or women planning to become pregnant or initiate breastfeeding.
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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.
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Q32 Bio Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADX-914-202