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
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 Design
| Study Type: | Interventional (Clinical Trial) |
| Estimated Enrollment: | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date: | September 30, 2022 |
| Estimated Primary Completion Date: | February 28, 2024 |
| Estimated Study Completion Date: | May 30, 2024 |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- 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
- Body weight ≤ 50.0 kg for men and ≤ 45.0 kg for women and > 100 kg at Screening
- 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
- A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)
- 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
- Systemic, topical or device-based therapy of AD
- Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring
- Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on atopic dermatitis
- 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
- Pregnant or lactating women, or women planning to become pregnant or initiate breastfeeding.
- 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.