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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-629 250 mg administered orally twice daily (BID) for approximately 12 weeks. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-629 | Drug | ADX-629 administered orally twice daily (BID) for approximately 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score | The number of subjects with a ≥ 50% reduction change from baseline for PASI score at Week 12 (end of treatment) was assessed on a 0 to 72 scale (0 = none, 72 = maximum severity). 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 Week 1 - Week 12. Baseline was the day prior to randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TCR Medical Corporation | San Diego | California | 92123 | United States |
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Ten subjects were enrolled in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | ADX-629 | ADX-629 250mg was administered orally twice daily (BID) for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | ADX-629 | ADX-629 250mg was administered orally BID for 12 weeks. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population | Posted | Mean | Standard Deviation | score on a scale | The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization. |
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Approximately 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADX-629 | ADX-629 250mg was administered orally BID for 12 weeks. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2021 | Jan 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2022 | Jan 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000716647 | ADX-629 |
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| Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score | The number of subjects with a ≥ 75% reduction change from baseline for PASI score at Week 12 (end of treatment) was assessed on a 0 to 72 scale (0 = none, 72 = maximum severity). 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 Week 1 - Week 12. Baseline was Day 1 prior to randomization. |
| Change From Baseline in the Investigator's Global Assessment (IGA) | The change from baseline for IGA score is based on a five-point scale ranging from 0 to 4 (0 = clear, 4 = severe). 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Total Body Surface Area Affected | Mean | Standard Deviation | Percentage (%) |
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| Participants |
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| Secondary | Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score | The number of subjects with a ≥ 50% reduction change from baseline for PASI score at Week 12 (end of treatment) was assessed on a 0 to 72 scale (0 = none, 72 = maximum severity). MMRM analysis was performed using change from baseline as the dependent variable, baseline as a covariate, and visit as a factor. | Safety population | Posted | Count of Participants | Participants | The efficacy assessment period was Week 1 - Week 12. Baseline was the day prior to randomization. |
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| Secondary | Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score | The number of subjects with a ≥ 75% reduction change from baseline for PASI score at Week 12 (end of treatment) was assessed on a 0 to 72 scale (0 = none, 72 = maximum severity). MMRM analysis was performed using change from baseline as the dependent variable, baseline as a covariate, and visit as a factor. | Safety population | Posted | Count of Participants | Participants | The efficacy assessment period was Week 1 - Week 12. Baseline was Day 1 prior to randomization. |
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| Secondary | Change From Baseline in the Investigator's Global Assessment (IGA) | The change from baseline for IGA score is based on a five-point scale ranging from 0 to 4 (0 = clear, 4 = severe). MMRM analysis was performed using change from baseline as the dependent variable, baseline as a covariate, and visit as a factor. | Safety population | Posted | Least Squares Mean | Standard Error | score on a scale | The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization. |
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| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Measurements |
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