A Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Subjects With Plaque Psoriasis

February 24, 2025 updated by: Aldeyra Therapeutics, Inc.

A Multi-Center, Open-Label, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects With Plaque Psoriasis

A Multi-Center, Open-Label, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Plaque Psoriasis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • TCR Medical Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject is a male or non-pregnant female 18 years of age or older.
  • Subject has provided written informed consent.
  • Females must be post-menopausal, surgically sterile, or use a highly effective method of birth control during the trial and for 30 days after the last administration of test article. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
  • Male subjects who are not surgically sterile (e.g., vasectomy performed at least 6 months prior to trial entry) and are sexually active with a female partner who is of childbearing potential must agree to use an effective form of birth control for the duration of the trial and for 90 days after completion of treatment.
  • Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of plaque psoriasis or exposes the subject to an unacceptable risk by trial participation.

Exclusion Criteria:

  • Subject is pregnant, lactating, or is planning to become pregnant during the trial.
  • Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis or which exposes the subject to an unacceptable risk by trial participation.
  • Subject is currently enrolled in an investigational drug, biologic, or device trial.
  • Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Baseline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ADX-629 250 mg administered orally twice daily (BID) for approximately 12 weeks.
Drug: ADX-629
ADX-629 administered orally twice daily (BID) for approximately 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Psoriasis Area and Severity Index (PASI)
Time Frame: The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.
The change from baseline for PASI score was assessed on a 0 to 72 scale (0 = none, 72 = maximum severity). Mixed model for repeated measures (MMRM) analysis was performed using change from baseline as the dependent variable, baseline as a covariate, and visit as a factor.
The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score
Time Frame: The efficacy assessment period was Week 1 - Week 12. Baseline was the day prior to randomization.
The number of subjects with a ≥ 50% reduction change from baseline for PASI score at Week 12 (end of treatment) was assessed on a 0 to 72 scale (0 = none, 72 = maximum severity). MMRM analysis was performed using change from baseline as the dependent variable, baseline as a covariate, and visit as a factor.
The efficacy assessment period was Week 1 - Week 12. Baseline was the day prior to randomization.
Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score
Time Frame: The efficacy assessment period was Week 1 - Week 12. Baseline was Day 1 prior to randomization.
The number of subjects with a ≥ 75% reduction change from baseline for PASI score at Week 12 (end of treatment) was assessed on a 0 to 72 scale (0 = none, 72 = maximum severity). MMRM analysis was performed using change from baseline as the dependent variable, baseline as a covariate, and visit as a factor.
The efficacy assessment period was Week 1 - Week 12. Baseline was Day 1 prior to randomization.
Change From Baseline in the Investigator's Global Assessment (IGA)
Time Frame: The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.
The change from baseline for IGA score is based on a five-point scale ranging from 0 to 4 (0 = clear, 4 = severe). MMRM analysis was performed using change from baseline as the dependent variable, baseline as a covariate, and visit as a factor.
The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aldeyra Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADX-629-PS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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