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

NCT04908514 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-629-PS-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Plaque Psoriasis

Outcome Measures

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.

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

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (1)

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

EXPERIMENTAL

Drug: ADX-629

Interventions

ADX-629 DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

TCR Medical Corporation

San Diego, California, 92123, United States

Location

MeSH Terms

Interventions

ADX-629

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: May 7, 2021
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)