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Phase 4 N=70 Treatment

Vascular Inflammation in Psoriasis - Apremilast

Psoriasis · Cardiovascular Diseases

Enrolled (actual)
70
Serious AEs
8.6%
Results posted
Nov 2022
Primary outcome: Primary: Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Baseline and Week 16. — -0.017 ratio — p=0.612

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Apremilast (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Aug 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Baseline and Week 16.
-0.017 0.612
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Ferritin
-13.416 0.083
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: C Reactive Protein (CRP)
-414.175 0.617
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Intercellular Adhesion Molecule (ICAM)-1
-169.902 0.524
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Serum Amyloid-A (SAA)
46.047 0.972
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Vascular Cell Adhesion Molecule (VCAM)-1
-11.201 0.315
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Interferon (IFN)-Gamma
-1.944 0.443
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Interleukin (IL)-1b
-0.472 0.027 sig
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-10
-0.054 0.390
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-17A
-0.947 0.116
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-6
2.727 0.331
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-8
24.014 0.225
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL-9
-0.090 0.141
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Monocyte Chemoattractant Protein (MCP)-1
3.056 0.882
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Tumor Necrosis Factor (TNF)-Alpha
17.914 0.326
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: IL2RA
-3.308 0.094
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: GlycA
10.690 0.087
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Cholesterol Efflux Capacity
-0.010 0.771
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Triglyceride
-3.542 0.491
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Total Cholesterol
0.254 0.924
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: High-density Lipoprotein (HDL) - Cholesterol (C)
0.136 0.868
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Number (P)
0.058 0.922
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: HDL-Particle Size (Z)
-0.071 0.192
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Small (S)-HDL-P
0.507 0.453
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Medium (M)-HDL-P
-0.203 0.714
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Large and Medium (LM)-HDL-P
-0.442 0.434
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Large (L)-HDL-P
-0.231 0.329
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Low-density Lipoprotein (LDL)-C
0.119 0.963
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-P
-21.712 0.400
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: LDL-Z
0.086 0.223
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-LDL-P
-31.780 0.241
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-LDL-P
21.763 0.348
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Large (VL)-LDL-P
-18.678 0.424
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Very Low-density Lipoprotein (VLDL)-P
1.227 0.667
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Z
-1.607 0.135
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: VLDL-Triglycerides (TG)
-4.393 0.331
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-VLDL-P
1.371 0.538
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: M-VLDL-P
0.625 0.791
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: LM-VLDL-P
-0.214 0.925
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-VLDL-P
-0.900 0.161
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Intermediate-density Lipoprotein (IDL)-P
-11.763 0.546
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein A1 (ApoA1)
0.939 0.667
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Apolipoprotein B (ApoB)
0.308 0.840
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: TRLTG
-5.142 0.367
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein Cholesterol) TRLC
-0.352 0.773
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: (Triglyceride-Rich Lipoprotein) TRLP
0.283 0.968
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: VS-TRLP
0.445 0.953
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: S-TRLP
0.534 0.911
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: M-TRLP
0.115 0.944
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: L-TRLP
-0.811 0.226
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: VL-TRLP
-0.000 0.988
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Insulin
159.448 0.189
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
0.551 0.488
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Glucose
2.615 0.523
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Diabetes Risk Index (DRI)
-2.978 0.060
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Lipoprotein Insulin Resistance Index (LP-IR)
-0.763 0.777
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Leptin
-84.193 0.946
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Adiponectin
-1.430 0.351
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Fetuin A
-50.732 0.041 sig
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Citrate
0.429 0.884
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Valine
-14.301 0.018 sig
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Leucine
-9.185 0.046 sig
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Isoleucine
-6.018 0.018 sig
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Alanine
-20.059 0.283
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: BCAA
-29.505 0.010 sig
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Ketone Bodies
-30.319 0.371
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Beta Hydroxybutyrate
-13.859 0.555
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetoacetic Acid
0.711 0.533
PRIMARY
Changes in Cardiometabolic Markers Between Baseline and Week 16: Acetone
-17.171 0.137
SECONDARY
Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Visceral Adipose Tissue
-10.681; -12.519; 2.189 0.001 sig
SECONDARY
Changes in Body Composition as Measured by FDG-PET/CT Between Week 52 and and Earlier Time Points (Baseline and Week 16): Subcutaneous Adipose Tissue
-19.857; -19.585; 0.638 0.001 sig
SECONDARY
Changes in Physician Reported Outcomes: Psoriasis Area and Severity Index (PASI)
-10.778; -9.903 <0.001 sig
SECONDARY
Changes in Physician Reported Outcomes: Physician Global Assessment (PGA)
-1.200; -1.067 <0.001 sig
SECONDARY
Changes in Patient Reported Outcomes: Dermatology Life Quality Index (DLQI)
-6.050; -5.692 <0.001 sig
SECONDARY
Changes in Patient Reported Outcomes: Pruritis by Visual Analog Scales (VAS)
-27.527; -19.110 <0.001 sig
SECONDARY
Change in Vascular Inflammation of the Five Aortic Segments as Measured by FDG-PET/CT Between Week 52, 16, and Baseline.
-0.067; -0.099; 0.028; -0.062; -0.080; 0.010
SECONDARY
Change in Total Vascular Inflammation of the Aorta as Measured by FDG-PET/CT Between Week 52 and Earlier Time Points.
-0.069; -0.016 0.092
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ferritin
-22.645; -1.736 0.020 sig
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): CRP
36.050; -246.058 0.973
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ICAM-1
41.059; 292.802 0.951
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): SAA
1586.025; 2799.836 0.614
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VCAM-1
10.253; 24.967 0.322
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IFN-gamma
0.281; 4.717 0.960
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-1b
0.285; 0.624 0.501
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-10
0.631; 0.689 0.259
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-17A
-1.383; 0.141 0.140
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-6
22.680; 18.344 0.302
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-8
369.437; 330.646 0.297
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL-9
-0.025; 0.080 0.812
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): MCP-1
101.704; 78.605 0.283
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TNF-alpha
100.589; 72.650 0.170
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IL2RA
-1.557; 0.782 0.526
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): GlycA
4.324; -8.703 0.584
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Cholesterol Efflux Capacity
-0.159; -0.111 0.005 sig
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Triglyceride
4.684; 12.526 0.533
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Total Cholesterol
4.316; 7.474 0.338
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-C
1.842; 1.711 0.102
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-P
0.953; 1.092 0.226
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HDL-Z
0.053; 0.089 0.384
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-HDL-P
0.434; 0.118 0.636
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-HDL-P
0.203; 0.500 0.800
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-HDL-P
0.595; 1.061 0.440
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-HDL-P
0.332; 0.503 0.278
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-C
1.158; 4.737 0.795
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-P
5.605; 78.105 0.880
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LDL-Z
0.037; -0.118 0.746
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-LDL-P
-9.184; 53.605 0.814
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-LDL-P
25.105; -1.658 0.494
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-LDL-P
9.605; 71.605 0.777
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-P
4.934; 0.645 0.241
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-Z
-0.039; 3.113 0.977
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VLDL-TG
3.553; 10.458 0.591
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-VLDL-P
2.913; -1.842 0.260
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-VLDL-P
1.753; 1.008 0.545
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LM-VLDL-P
1.676; 2.432 0.542
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-VLDL-P
0.095; 1.724 0.918
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): IDL-P
-12.316; 18.211 0.510
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoA1
5.792; 5.272 0.046 sig
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): ApoB
2.225; 3.360 0.392
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLTG
4.520; 14.465 0.584
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLC
1.547; 2.598 0.421
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): TRLP
5.539; 8.555 0.611
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VS-TRLP
0.619; 7.361 0.957
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): S-TRLP
2.714; -2.990 0.698
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): M-TRLP
1.976; 2.204 0.362
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): L-TRLP
0.233; 1.981 0.813
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): VL-TRLP
-0.003; -0.002 0.752
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Insulin
421.436; 330.523 0.251
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): HOMA-IR
1.814; 0.753 0.215
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Glucose
8.032; 2.604 0.307
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): DRI
-2.834; 1.765 0.139
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): LP-IR
-1.158; 2.684 0.721
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leptin
-498.841; 304.320 0.804
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Adiponectin
-2.106; 1.268 0.293
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Fetuin A
-53.518; 36.686 0.101
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Citrate
-5.547; -4.766 0.137
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Valine
-12.589; 6.269 0.115
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Leucine
-8.223; 1.313 0.122
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Isoleucine
-3.541; 5.203 0.321
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Alanine
23.209; 39.496 0.352
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): BCAA
-24.353; 12.785 0.094
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Ketone Bodies
-79.323; -48.175 0.024 sig
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Beta Hydroxybutyrate
-48.450; -38.228 0.042 sig
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetoacetic Acid
1.616; 0.993 0.446
SECONDARY
Changes in Cardiometabolic Markers Between Week 52 and Earlier Time Points (Baseline and Week 16): Acetone
-32.489; -10.939 0.014 sig

Summary

The purpose of the VIP-A study is to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis.

Eligibility Criteria

Inclusion Criteria

  • Males and females 18 years of age and older.
  • Clinical diagnosis of psoriasis for at least 6 months as determined by medical history interview and confirmation of diagnosis through physical examination by Investigator.
  • Stable plaque psoriasis for at least 2 months before screening and at baseline (Week 0) as determined by medical history interview.
  • Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the baseline (Week 0) visit.
  • Psoriasis Area and Severity Index (PASI) score of ≥ 12 at the Baseline (Week 0) visit.
  • Participant is a candidate for systemic therapy and has active psoriasis despite prior treatment with topical agents.
  • Women are eligible to participate in the study if they meet one of the following criteria:
  • Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and baseline. Women of childbearing potential must undergo periodic pregnancy testing during the study and agree to use at least one of the following methods of contraception throughout the study duration and for at least 28 days after taking the last dose of investigational product:
  • Oral contraceptives
  • Transdermal contraceptives
  • Injectable or implantable methods
  • Intrauterine devices
  • Vaginal ring
  • Vasectomized partner
  • Barrier methods (Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.);
  • Women who are postmenopausal (for at least one year), sterile, or hysterectomized;
  • Women who have undergone tubal ligation will be required to undergo periodic pregnancy testing during the duration of the study
  • Sexual abstinence, defined as total abstinence from sexual intercourse, is considered an adequate form of contraception. (Agreement to comply with sexual abstinence must be recorded in the source document).
  • Participants using oral or parenteral forms of contraceptives must have been using these methods for at least 90 days prior to baseline visit.
  • Men (including those who have had a vasectomy), who engage in activity in which conception is possible, are eligible to participate if they:
  • Use barrier contraception (male latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.
  • Participant is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile and physical examination performed at screening.

Exclusion Criteria

  • Prior treatment with apremilast.
  • Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
  • Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
  • Cannot avoid topical prescription medications for psoriasis for at least 14 days prior to the baseline visit (week 0) and during the study, with the exception of hydrocortisone 2.5% for the face and intertriginous areas.
  • Cannot avoid ultraviolet B (UVB) phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 0) visit and during the study.
  • Cannot avoid psoralen-ultraviolet A (UVA) phototherapy for at least 30 days prior to the Baseline (Week 0) visit and during the study.
  • Use of systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study:
  • Systemic therapies must be discontinued at least 30 days prior to the Baseline (Week 0) visit except for biologics.
  • All biologics, except interleukin (IL)-12/IL-23 antagonists, must be discontinued for at lea
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03082729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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