Clinical trial NCT04908514: A Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Subjects With Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change From Baseline in the Psoriasis Area and Severity Index (PASI)
timeFrame: The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.
Secondary outcomes:
measure: Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score
timeFrame: The efficacy assessment period was Week 1 - Week 12. Baseline was the day prior to randomization.
measure: Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score
timeFrame: The efficacy assessment period was Week 1 - Week 12. Baseline was Day 1 prior to randomization.
measure: Change From Baseline in the Investigator's Global Assessment (IGA)
timeFrame: The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
Study officials:
References: