NCT05717920

Brief Summary

A Phase 2, multicenter, adaptive 2-part clinical trial designed to evaluate the safety and efficacy of ADX-629 alone and in combination with standard-of-care in adults with atopic dermatitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

January 25, 2023

Last Update Submit

October 31, 2024

Conditions

Atopic Dermatitis

Keywords

eczemaatopicadaptiveAldeyraADX-629Reactive aldehyde species (RASP)

Outcome Measures

Primary Outcomes (1)

  • Adverse Event (AE) Query

    Incidence and severity of AEs

    From Day 1 to Day 90

Secondary Outcomes (1)

  • Investigator Global Assessment (IGA) Score

    From Day 1 to Day 90

Study Arms (1)

ADX-629

EXPERIMENTAL
Drug: ADX-629 (Open-label)

Interventions

ADX-629 (Open-label)DRUG

ADX-629 (250 mg) administered twice daily for 90 days

ADX-629

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years of age
  • History of atopic dermatitis, according to American Academy of Dermatology criteria, that has been present for at least 6 months
  • Mild, moderate, or severe atopic dermatitis, defined as an IGA score of ≥2 at Baseline
  • Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable

You may not qualify if:

  • Presence of clinically significant kidney disease or an estimated gloverular filtration rate (eGFR) of less than or equal to 45 milliliters/min/1.73 m2 during screening
  • History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bexley Dermatology Research

Bexley, Ohio, 43209, United States

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

ADX-629

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
Part 1 is an open-label trial.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 8, 2023

Study Start

February 15, 2023

Primary Completion

November 21, 2023

Study Completion

November 21, 2023

Last Updated

November 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)