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A Study to Evaluate the Safety and Effectiveness of ADX-914 in Subjects with Moderate to Severe Atopic Dermatitis
EU CTIS ID: 2023-510238-10-00
What this study is testing
Part A only: To identify the recommended ADX-914 dose for Part B Part B only: To evaluate the efficacy of ADX-914 vs placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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: 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.