Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)

Launched by Q32 BIO INC. · Aug 18, 2022

Keywords

ClinConnect Summary

The SIGNAL-AD clinical trial is studying a new treatment called ADX-914 for adults with moderate to severe atopic dermatitis, a skin condition that can cause intense itching and inflammation. This trial is in its second phase and is designed to evaluate how safe and effective ADX-914 is compared to a placebo (a treatment with no active medication) in helping manage the symptoms of atopic dermatitis. To participate, individuals must be at least 18 years old, have had chronic atopic dermatitis for at least three years, and show moderate to severe disease activity based on specific measures.

Participants in the trial will be randomly assigned to receive either ADX-914 or a placebo, and neither the participants nor the researchers will know which treatment each person is getting. This is to ensure that the results are unbiased. Eligible individuals will need to have had an inadequate response to other approved treatments for their condition. It's important for potential participants to know that there are certain health conditions and recent treatments that could make them ineligible for the study. Those interested should also be aware that the trial is currently active, but not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• 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.