Atopic Dermatitis (Q32 Bio Inc. Study)

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 ‚Č•18 years, inclusive, at time of informed consent, with chronic AD (duration of disease ‚Č•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 ‚Č•10%
    • EASI Score ‚Č•12
    • Investigators Global Score (IGA) ‚Č•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 ‚ȧ 50.0 kg for men and ‚ȧ 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¬ģTB 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.