MedPath

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

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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ADX-629 250 mg administered orally twice daily (BID) for approximately 12 weeks.ADX-629-
Primary Outcome Measures
NameTimeMethod
Adverse Event AssessmentSafety Assessment Period (Day 1 - 85)

Adverse Event Collection

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

TCR Medical Corporation

🇺🇸

San Diego, California, United States

© Copyright 2025. All Rights Reserved by MedPath