NCT04908514CompletedPhase 2
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Aldeyra Therapeutics, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change From Baseline in the Psoriasis Area and Severity Index (PASI)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ADX-629 250 mg administered orally twice daily (BID) for approximately 12 weeks.
Experimental
Intervention: ADX-629 (Drug)
Outcomes
Primary Outcomes
Change From Baseline in the Psoriasis Area and Severity Index (PASI)
Time Frame: 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 Outcomes
- 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.)
Investigators
Study Sites (1)
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