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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: ADX-629

• Registration Number: NCT04908514
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-01
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-21
• Status Verified: 2023-01
• Disposition First Submitted: 2023-01-09
• Results First Submitted: 2025-02-03
• Results First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Results First Posted: 2025-03-11
• Disposition First Posted: 2025-03-11
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADX-629 250 mg administered orally twice daily (BID) for approximately 12 weeks.	ADX-629	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Psoriasis Area and Severity Index (PASI)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score	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.
Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score	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.
Change From Baseline in the Investigator's Global Assessment (IGA)	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.

Trial Locations

Locations (1)

TCR Medical Corporation; 🇺🇸 San Diego, California, United States