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Atopic DermatitisPhase 2NCT05509023

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

A Phase 2 study testing ADX-914 in people with Atopic Dermatitis, run by Q32 Bio Inc. at 24 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
ADX-914
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
24 sitesUnited States
Study dates
30 Sep 2022to Dec 2024
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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)

Who cannot join

  • Body weight ≤ 50.0 kg for men and ≤ 45.0 kg for women and > 120 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Cahaba Dermatology Skin Health Center

    Birmingham, Alabama, 35244

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • First OC Dermatology

    Fountain Valley, California, 92708

  • North Texas Center for Clinical Research

    Frisco, Texas, 75034

  • RM Medical Research Inc.

    Homestead, Florida, 33175

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Visage Clinical Research

    Largo, Maryland, 20774

  • California Allergy and Asthma Medical Group- Los Angeles

    Los Angeles, California, 90025

  • Medical Research Center of Miami

    Miami, Florida, 33134

  • Well Pharma Medical Research Corporation

    Miami, Florida, 33173

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150

  • Sneeze wheeze and Itch Associates LLC

    Normal, Illinois, 61761

  • Apex Clinical Research Center

    Painesville, Ohio, 33612

  • Integrative Skin Science and Research

    Sacramento, California, 95815

  • JBR Clinical Research

    Salt Lake City, Utah, 84107

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Advanced Medical Research, PC

    Sandy Springs, Georgia, 30328

  • Dermatology Institute and Skin Care Center

    Santa Monica, California, 90404

  • Dermatology of Seattle & Bellevue

    Seattle, Washington, 98004

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202

  • GCP Research

    St. Petersburg, Florida, 33705

  • Torrance Clinical Research Institute Inc.

    Torrance, California, 90505

  • Revival Research Corporation- Clinedge

    Troy, Michigan, 48084

  • Integrated Research of Inland, Inc.

    Upland, California, 91786

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
ADX-914, Placebo
Keywords
Atopic Dermatitis, Eczema Dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADX-914Drug

    Subcutaneous administration of ADX-914

  • PlaceboDrug

    Subcutaneous administration of Placebo

Study groups in NCT05509023
Study groupRoleWhat they receive
ADX-914ExperimentalNot described
Receives: Drug: ADX-914
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest

    Measured: 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

    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).

    Measured: 14 Weeks

Secondary outcomes (5)

  1. Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score

    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)

    Measured: 24 Weeks

  2. Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score

    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)

    Measured: 24 Weeks

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

    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)

    Measured: 24 Weeks

  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

    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

    Measured: 24 Weeks

  5. Incidence of adverse events

    As evaluated by vital signs, physical examinations, laboratory evaluations, and 12-lead electrocardiograms

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start30 Sep 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05509023
Sponsor's protocol ID
ADX-914-202
Status last verified
Oct 2024
First submitted
12 Aug 2022
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADX-914 in people with Atopic Dermatitis, run by Q32 Bio Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest (time frame: 14 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05509023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.

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