CClinicalTrials.gg
Sign In
CompletedNCT04908514Updated Mar 11, 2025Results posted

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

A Phase 2 interventional study of ADX-629 in Plaque Psoriasis, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Aldeyra Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Plaque Psoriasis

Browse trials for

03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 10 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Aldeyra Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 22 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    ADX-629 250 mg administered orally twice daily (BID) for approximately 12 weeks.

    Drug: ADX-629

Interventions

  • DrugADX-629

    ADX-629 administered orally twice daily (BID) for approximately 12 weeks.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in the Psoriasis Area and Severity Index (PASI)

    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.

    Time frame: The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.

Secondary outcomes

  1. Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score

    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.

    Time frame: The efficacy assessment period was Week 1 - Week 12. Baseline was the day prior to randomization.

  2. Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score

    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.

    Time frame: The efficacy assessment period was Week 1 - Week 12. Baseline was Day 1 prior to randomization.

  3. Change From Baseline in the Investigator's Global Assessment (IGA)

    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.

    Time frame: The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.

07

Results

Posted Mar 11, 2025

Participant flow

Participant flow — Overall Study
MilestoneADX-629
Started10
Completed7
Not completed3
Withdrew: Lost to follow-up2
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryChange From Baseline in the Psoriasis Area and Severity Index (PASI)

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.

Time frame:
The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.
Reported as:
Mean · score on a scale
Change From Baseline in the Psoriasis Area and Severity Index (PASI)
score on a scaleADX-629
Week 4-4.3 ± 5.2
Week 8-7.6 ± 6.9
Week 12-8.0 ± 7.5
SecondaryNumber of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score

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.

Time frame:
The efficacy assessment period was Week 1 - Week 12. Baseline was the day prior to randomization.
Reported as:
Count of participants · Participants
Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score
ParticipantsADX-629
Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score3
SecondaryNumber of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score

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.

Time frame:
The efficacy assessment period was Week 1 - Week 12. Baseline was Day 1 prior to randomization.
Reported as:
Count of participants · Participants
Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score
ParticipantsADX-629
Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score2
SecondaryChange From Baseline in the Investigator's Global Assessment (IGA)

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.

Time frame:
The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Investigator's Global Assessment (IGA)
score on a scaleADX-629
Week 4-0.50 ± 0.02
Week 8-0.68 ± 0.02
Week 12-0.85 ± 0.35

Adverse events

Collected over Approximately 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ADX-6290/10 (0%)0/10 (0%)3/10 (30%)
Most frequent other events
Most frequent other events
EventADX-629
PsoriasisSkin and subcutaneous tissue disorders1/10
DiarrhoeaGastrointestinal disorders1/10
Ligament SprainInjury, poisoning and procedural complications1/10

Baseline characteristics

Intent-to-treat population

Age, Continuous
Age, Continuous(years)ADX-629
Mean42.2 ± 15.0
Sex: Female, Male
Sex: Female, Male(Participants)ADX-629
Female2
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ADX-629
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White8
More than one race1
Unknown or Not Reported0
Total Body Surface Area Affected
Total Body Surface Area Affected(Percentage (%))ADX-629
Mean19.9 ± 15.6
08

Study locations

1 site
  • TCR Medical Corporation
    San Diego, California 92123, United States
09

References and documents

Study documents

  • Study protocol · Jun 9, 2021
  • Statistical analysis plan · Feb 8, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04908514
Lead sponsor
Aldeyra Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jun 1, 2021
Start date
May 7, 2021
Primary completion
Jan 21, 2022
Completion
Jan 21, 2022
Results posted
Mar 11, 2025
Last update
Mar 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Psoriasis→

Other studies from this sponsor

Aldeyra Therapeutics, Inc.

Start the discussion