Trial Outcomes & Findings for Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast (NCT NCT03442088)
NCT ID: NCT03442088
Last Updated: 2023-01-20
Results Overview
For each subject, we will identify a target biomarker of abnormally elevated monocytes, among 1.) intermediate, or 2.) doublets, or 3.) platelet doubles. Each subject will thus have one identified monocyte biomarker for which relative percent change will be its basis for analysis in the primary outcome measure. We will specifically assess change from baseline to 16 weeks by computing relative percent reduction for each subject being treated. Note for example that a change of 1.5% to 1.2% is (1 - (1.2/1.5))\*100% = 20% reduction. The median and other summary statistics of these percent change values will be computed. Wilcoxon's signed rank test will be used to evaluate the null hypothesis of the median percent change being 0.
COMPLETED
PHASE2
28 participants
Baseline, Week 16
2023-01-20
Participant Flow
Participant milestones
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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Overall Study
STARTED
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28
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Lack of Efficacy
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2
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Overall Study
Lost to Follow-up
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2
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Baseline Characteristics
Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast
Baseline characteristics by cohort
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
n=28 Participants
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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Age, Continuous
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44.7 years
STANDARD_DEVIATION 12.6 • n=99 Participants
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Sex: Female, Male
Female
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10 Participants
n=99 Participants
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Sex: Female, Male
Male
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18 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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28 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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5 Participants
n=99 Participants
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Race (NIH/OMB)
White
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22 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 16Population: 1 subject missed interim visits, so data was not analyzed for this one participant.
For each subject, we will identify a target biomarker of abnormally elevated monocytes, among 1.) intermediate, or 2.) doublets, or 3.) platelet doubles. Each subject will thus have one identified monocyte biomarker for which relative percent change will be its basis for analysis in the primary outcome measure. We will specifically assess change from baseline to 16 weeks by computing relative percent reduction for each subject being treated. Note for example that a change of 1.5% to 1.2% is (1 - (1.2/1.5))\*100% = 20% reduction. The median and other summary statistics of these percent change values will be computed. Wilcoxon's signed rank test will be used to evaluate the null hypothesis of the median percent change being 0.
Outcome measures
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
n=22 Participants
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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The Primary Outcome Measure Will be to Evaluate Change in Aberrant Inflammatory Profiles of Activated Blood Monocytes (Aberrant-monocyte Endotype Patients (AM-endotype).
Baseline
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0.5665 Percent change
Standard Deviation 0.5135
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The Primary Outcome Measure Will be to Evaluate Change in Aberrant Inflammatory Profiles of Activated Blood Monocytes (Aberrant-monocyte Endotype Patients (AM-endotype).
Week 16
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0.1715 Percent change
Standard Deviation 0.2635
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SECONDARY outcome
Timeframe: Baseline, Week 16Population: Analysis was only done on participants had complete data sets including sequencing.
To assess change in serum myeloperoxidase in the identified patient AM-endotype computing relative percent reduction for each subject being treated and serum marker. The median and other summary statistics of these percent change values will be computed
Outcome measures
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
n=17 Participants
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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Change in Serum Myeloperoxidase
Baseline
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24198 Pg/mL
Standard Deviation 3835
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Change in Serum Myeloperoxidase
Week 16
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24294 Pg/mL
Standard Deviation 4722
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SECONDARY outcome
Timeframe: Baseline, Week 16Population: Analysis was only done on participants had complete data sets including sequencing.
To assess change in in the identified patient AM-endotype computing relative percent reduction for each subject being treated and serum marker. The median and other summary statistics of these percent change values will be computed
Outcome measures
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
n=17 Participants
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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Change in TNF Alpha
Baseline
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14.95 Pg/mL
Standard Deviation 4.017
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Change in TNF Alpha
Week 16
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14.26 Pg/mL
Standard Deviation 3.383
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SECONDARY outcome
Timeframe: Baseline, Week 16Population: Analysis was only done on participants had complete data sets including sequencing.
To assess change in IL-17 in the identified patient AM-endotype computing relative percent reduction for each subject being treated and serum marker. The median and other summary statistics of these percent change values will be computed
Outcome measures
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
n=17 Participants
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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Change in IL-17
Baseline
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1.513 Pg/mL
Standard Deviation 5.76
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Change in IL-17
Week 16
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-0.8315 Pg/mL
Standard Deviation 5.824
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SECONDARY outcome
Timeframe: Baseline, Week 16Population: Analysis was only done on participants had complete data sets including sequencing.
To assess change in Tissue Factor in the identified patient AM-endotype computing relative percent reduction for each subject being treated and serum marker. The median and other summary statistics of these percent change values will be computed
Outcome measures
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
n=17 Participants
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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Change in Tissue Factor
Week 16
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75.52 Pg/mL
Standard Deviation 28.03
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Change in Tissue Factor
Baseline
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72.28 Pg/mL
Standard Deviation 23.72
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OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksTo assess change in quantitation of additional monocyte and neutrophil markers, including CD18/CD11b and NETotic neutrophils by computing relative percent reduction in circulating CD18/CD11b and NETotic neutrophils for each subject being treated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksTo assess change in expression levels of monocyte transcriptome biomarkers using quantitative PCR to measure changes from baseline to 16 weeks in identified monocyte genes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksCalculate the percent change in Dermatology Life Quality Index (DLQI) from baseline to 16 weeks in patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksCalculate the percent change Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) from baseline to 16 weeks in patients treated with apremilast 30 mg BID
Outcome measures
Outcome data not reported
Adverse Events
Apremilast for Treatment of Psoriasis With the AM-endotype
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Apremilast for Treatment of Psoriasis With the AM-endotype
n=28 participants at risk
Psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Apremilast: Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dose titration from Day 1 (10mg) to Day 5 (30mg). Following titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
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|---|---|
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Gastrointestinal disorders
Nausea
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3.6%
1/28 • Number of events 5 • While patients were on treatment, 16 weeks.
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Gastrointestinal disorders
Diarrhea
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3.6%
1/28 • Number of events 6 • While patients were on treatment, 16 weeks.
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Infections and infestations
Sinus/viral infection
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3.6%
1/28 • Number of events 3 • While patients were on treatment, 16 weeks.
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Surgical and medical procedures
Arthroscopic procedure
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3.6%
1/28 • Number of events 1 • While patients were on treatment, 16 weeks.
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Skin and subcutaneous tissue disorders
Contact dermatitis to watch
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3.6%
1/28 • Number of events 1 • While patients were on treatment, 16 weeks.
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Skin and subcutaneous tissue disorders
Psoriasis flare
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3.6%
1/28 • Number of events 3 • While patients were on treatment, 16 weeks.
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Metabolism and nutrition disorders
Hyponatremia
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3.6%
1/28 • Number of events 1 • While patients were on treatment, 16 weeks.
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Respiratory, thoracic and mediastinal disorders
Cough
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3.6%
1/28 • Number of events 2 • While patients were on treatment, 16 weeks.
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Infections and infestations
COVID
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3.6%
1/28 • Number of events 1 • While patients were on treatment, 16 weeks.
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General disorders
Headache
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3.6%
1/28 • Number of events 2 • While patients were on treatment, 16 weeks.
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Musculoskeletal and connective tissue disorders
Muscle spasm
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3.6%
1/28 • Number of events 1 • While patients were on treatment, 16 weeks.
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Musculoskeletal and connective tissue disorders
Sprained ankle
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3.6%
1/28 • Number of events 1 • While patients were on treatment, 16 weeks.
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Skin and subcutaneous tissue disorders
Itchiness
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3.6%
1/28 • Number of events 1 • While patients were on treatment, 16 weeks.
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Additional Information
Dr. Neil Korman, Director Clinical Trials Unit
University Hospitals Cleveland Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place