Status:

COMPLETED

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

Lead Sponsor:

Aldeyra Therapeutics, Inc.

Conditions:

Plaque Psoriasis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 7 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 21 2022

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04908514

Start Date

May 7 2021

End Date

January 21 2022

Last Update

March 11 2025

Active Locations (1)

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1

TCR Medical Corporation

San Diego, California, United States, 92123