Phase 4
N=70
Vascular Inflammation in Psoriasis - Apremilast
Psoriasis · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03082729 ↗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
| Outcome | Result | p-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
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.