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

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ClinicalTrials.gov Identifier: NCT05509023
Recruitment Status : Recruiting
First Posted : August 19, 2022
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Q32 Bio Inc.

Study Description
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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
Atopic Dermatitis Drug: ADX-914 Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 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 : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest [ Time Frame: 14 Weeks ]
  2. 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 [ Time Frame: 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 :
  1. Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score [ Time Frame: 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)

  2. Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score [ Time Frame: 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)

  3. Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90% [ Time Frame: 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)

  4. 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 [ Time Frame: 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

  5. Incidence of adverse events [ Time Frame: 24 Weeks ]
    As evaluated by vital signs, physical examinations, laboratory evaluations, and 12-lead electrocardiograms


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05509023


Contacts
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Contact: Kristin Orr 9193950132 korr@q32bio.com

Locations
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Sponsors and Collaborators
Q32 Bio Inc.
More Information
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Responsible Party: Q32 Bio Inc.
ClinicalTrials.gov Identifier: NCT05509023    
Other Study ID Numbers: ADX-914-202
First Posted: August 19, 2022    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Q32 Bio Inc.:
Atopic Dermatitis
Eczema Dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases