Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Subjects With Plaque Psoriasis (NCT NCT04908514)

Last Updated: 2025-03-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

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

Results posted on

2025-03-11

Participant Flow

Ten subjects were enrolled in the trial.

Participant milestones

Participant milestones
Measure	ADX-629 ADX-629 250mg was administered orally twice daily (BID) for 12 weeks.
Overall Study STARTED	10
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	ADX-629 ADX-629 250mg was administered orally twice daily (BID) for 12 weeks.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADX-629 n=10 Participants ADX-629 250mg was administered orally BID for 12 weeks.
Age, Continuous	42.2 years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Total Body Surface Area Affected	19.9 Percentage (%) STANDARD_DEVIATION 15.6 • n=5 Participants

PRIMARY outcome

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

Population: Safety population

Outcome measures

Outcome measures
Measure	ADX-629 n=8 Participants ADX-629 250mg was administered orally BID for 12 weeks.
Change From Baseline in the Psoriasis Area and Severity Index (PASI) Week 4	-4.3 score on a scale Standard Deviation 5.2
Change From Baseline in the Psoriasis Area and Severity Index (PASI) Week 8	-7.6 score on a scale Standard Deviation 6.9
Change From Baseline in the Psoriasis Area and Severity Index (PASI) Week 12	-8.0 score on a scale Standard Deviation 7.5

SECONDARY outcome

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

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	ADX-629 n=7 Participants ADX-629 250mg was administered orally BID for 12 weeks.
Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score	3 Participants

SECONDARY outcome

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

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	ADX-629 n=7 Participants ADX-629 250mg was administered orally BID for 12 weeks.
Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score	2 Participants

SECONDARY outcome

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

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	ADX-629 n=7 Participants ADX-629 250mg was administered orally BID for 12 weeks.
Change From Baseline in the Investigator's Global Assessment (IGA) Week 4	-0.50 score on a scale Standard Error 0.02
Change From Baseline in the Investigator's Global Assessment (IGA) Week 8	-0.68 score on a scale Standard Error 0.02
Change From Baseline in the Investigator's Global Assessment (IGA) Week 12	-0.85 score on a scale Standard Error 0.35

Adverse Events

ADX-629

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ADX-629 n=10 participants at risk ADX-629 250mg was administered orally BID for 12 weeks.
Skin and subcutaneous tissue disorders Psoriasis	10.0% 1/10 • Number of events 1 • Approximately 12 weeks
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Number of events 1 • Approximately 12 weeks
Injury, poisoning and procedural complications Ligament Sprain	10.0% 1/10 • Number of events 1 • Approximately 12 weeks

Additional Information

Director of Clinical Trials

Aldeyra Therapeutics, Inc.

Phone: 781-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place