Plaque Psoriasis
Conditions
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
Interventions
DRUGADX-629
ADX-629 administered orally twice daily (BID) for approximately 12 weeks.
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Psoriasis Area and Severity Index (PASI) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
Countries
United States
Participant flow
Pre-assignment details
Ten subjects were enrolled in the trial.
Participants by arm
| Arm | Count |
|---|---|
| ADX-629 ADX-629 250mg was administered orally BID for 12 weeks. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | ADX-629 |
|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 15 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
| Total Body Surface Area Affected | 19.9 Percentage (%) STANDARD_DEVIATION 15.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADX-629 | Change From Baseline in the Psoriasis Area and Severity Index (PASI) | Week 4 | -4.3 score on a scale | Standard Deviation 5.2 |
| ADX-629 | Change From Baseline in the Psoriasis Area and Severity Index (PASI) | Week 8 | -7.6 score on a scale | Standard Deviation 6.9 |
| ADX-629 | Change From Baseline in the Psoriasis Area and Severity Index (PASI) | Week 12 | -8.0 score on a scale | Standard Deviation 7.5 |
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.
Time frame: The efficacy assessment period was baseline, Week 4, Week 8, and Week 12. Baseline was the day prior to randomization.
Population: Safety population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ADX-629 | Change From Baseline in the Investigator's Global Assessment (IGA) | Week 4 | -0.50 score on a scale | Standard Error 0.02 |
| ADX-629 | Change From Baseline in the Investigator's Global Assessment (IGA) | Week 8 | -0.68 score on a scale | Standard Error 0.02 |
| ADX-629 | Change From Baseline in the Investigator's Global Assessment (IGA) | Week 12 | -0.85 score on a scale | Standard Error 0.35 |
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.
Time frame: The efficacy assessment period was Week 1 - Week 12. Baseline was the day prior to randomization.
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADX-629 | Number of Subjects With a ≥ 50% Reduction Change From Baseline for PASI Score | 3 Participants |
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.
Time frame: The efficacy assessment period was Week 1 - Week 12. Baseline was Day 1 prior to randomization.
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADX-629 | Number of Subjects With a ≥ 75% Reduction Change From Baseline for PASI Score | 2 Participants |