Phase 2
Completed N=352
Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
Psoriasis · Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT00773734 ↗
Enrolled (actual)
352
Serious AEs
4.2%
Results posted
Nov 2014
Primary outcomePrimary: Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16 — 5.7; 11.2; 28.7; 40.9 percentage of participants — p=0.1846
Summary
The purpose of this study was to test if the drug apremilast was safe, if it helped improve psoriasis, and how well the participants tolerated it.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16 |
5.7; 11.2; 28.7; 40.9 | 0.1846 |
| SECONDARY Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24 |
18.0; 26.4; 39.8; 41.2; 44.4 | — |
| SECONDARY Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16 |
25.0; 38.2; 47.1; 60.2 | 0.0590 |
| SECONDARY Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24 |
38.2; 49.4; 65.9; 61.8; 75.0 | — |
| SECONDARY Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16 |
1.1; 4.5; 9.2; 11.4 | 0.1776 |
| SECONDARY Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24 |
4.5; 8.0; 14.8; 14.7; 16.7 | — |
| SECONDARY Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16 |
— | — |
| SECONDARY Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24 |
— | — |
| SECONDARY Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase |
— | — |
| SECONDARY Core Study: Percent Change From Baseline in PASI Score at Week 16 |
-20.3; -34.0; -45.4; -53.2 | 0.0156 sig |
| SECONDARY Core Study: Percent Change From Baseline in PASI Score at Week 24 |
-36.3; -46.5; -56.8; -61.7; -61.7 | — |
| SECONDARY Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16 |
— | — |
| SECONDARY Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24 |
— | — |
| SECONDARY Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase |
-8.0; -28.3; -38.0; -50.4 | 0.0020 sig |
| SECONDARY Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24 |
-28.1; -40.6; -54.0; -52.5; -54.2 | — |
| SECONDARY Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
-1.9; -3.2; -5.9; -4.4 | 0.1322 |
| SECONDARY Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24 |
-3.4; -6.2; -4.9; -6.4; -5.4 | — |
| SECONDARY Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16 |
-0.6; 2.8; 2.9; 3.0 | 0.0078 sig |
| SECONDARY Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16 |
0.7; 1.3; 2.1; 0.8 | 0.6097 |
| SECONDARY Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24 |
2.8; 3.9; 2.9; 2.8; 0.5 | — |
| SECONDARY Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24 |
1.1; 2.3; 1.0; 2.5; 2.7 | — |
| SECONDARY Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8) |
1200; 1257; 3477 | — |
| SECONDARY Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast |
238; 236; 670 | — |
| SECONDARY Core Study: Time to Maximum Plasma Concentration of Drug (Tmax) |
1.00; 1.50; 1.00 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52 |
14.9; 22.0; 36.2; 37.0; 33.3 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32 |
27.7; 38.0; 46.6; 33.3; 55.6 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40 |
21.3; 28.0; 34.5; 37.0; 44.4 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32 |
57.4; 72.0; 86.2; 74.1; 74.1 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40 |
48.9; 62.0; 82.8; 63.0; 66.7 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52 |
42.6; 48.0; 72.4; 55.6; 48.1 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32 |
10.6; 14.0; 19.0; 18.5; 25.9 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40 |
8.5; 14.0; 17.2; 18.5; 22.2 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52 |
4.3; 10.0; 13.8; 14.8; 11.1 | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32 |
— | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40 |
— | — |
| SECONDARY Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52 |
— | — |
| SECONDARY Extension Study: Time to Achieve PASI-75 During the Extension Study |
— | — |
| SECONDARY Extension Study: Time to Achieve PASI-50 During the Extension Study |
— | — |
| SECONDARY Extension Study: Time to Achieve PASI-90 During the Extension Study |
— | — |
| SECONDARY Extension Study: Time to Achieve PASI-100 During the Extension Study |
— | — |
| SECONDARY Extension Study: Percent Change in PASI Score at Week 32 |
-51.0; -63.1; -72.7; -64.0; -69.2 | — |
| SECONDARY Extension Study: Percent Change in PASI Score at Week 40 |
-55.9; -63.3; -71.1; -64.5; -71.7 | — |
| SECONDARY Extension Study: Percent Change in PASI Score at Week 52 |
-55.1; -58.9; -65.3; -62.7; -62.0 | — |
| SECONDARY Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32 |
— | — |
| SECONDARY Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40 |
— | — |
| SECONDARY Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52 |
— | — |
| SECONDARY Extension Study: Percent Change From Baseline in the Affected BSA at Week 32 |
-47.1; -65.1; -75.3; -62.6; -66.7 | — |
| SECONDARY Extension Study: Percent Change From Baseline in the Affected BSA at Week 40 |
-55.4; -65.4; -74.3; -66.2; -68.0 | — |
| SECONDARY Extension Study: Percent Change From Baseline in the Affected BSA at Week 52 |
-53.1; -58.3; -67.3; -67.4; -64.9 | — |
| SECONDARY Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32 |
-6.5; -7.5; -6.0; -8.1; 5.5 | — |
| SECONDARY Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40 |
-5.5; -6.6; -6.4; -7.1; -5.9 | — |
| SECONDARY Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52 |
-5.8; -6.1; -5.6; -6.8; -4.9 | — |
| SECONDARY Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32 |
5.2; 3.8; 2.9; 4.6; 2.8 | — |
| SECONDARY Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32 |
1.4; 2.6; 1.8; 3.1; 1.5 | — |
| SECONDARY Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40 |
5.4; 4.8; 1.7; 2.9; 3.8 | — |
| SECONDARY Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40 |
-0.2; 1.6; 1.7; 3.2; 1.8 | — |
| SECONDARY Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52 |
5.1; 4.1; 2.4; 4.7; 3.4 | — |
| SECONDARY Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52 |
1.2; 1.2; 2.0; 3.4; 0.3 | — |
| SECONDARY Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52 |
— | — |
| SECONDARY Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study. |
— | — |
| SECONDARY Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase) |
NA; NA; NA; NA; 5.3 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase |
57; 59; 67; 72; 11; 20 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period |
67; 97; 111; 23; 32; 46 | — |
| SECONDARY Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase |
6.5; 5.9; 6.0; 4.3 | — |
| SECONDARY Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase |
8.1; 10.0; 11.9; 6.3 | — |
| SECONDARY Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase |
— | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months |
60.0; 0.0; 40.0; 0.0; 50.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years |
20.0; 0.0; 30.0; 25.0; 50.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years |
60.0; 25.0; 10.0; 0.0; 30.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years |
40.0; 0.0; 0; 25.0; 30.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months |
100.0; 50.0; 70.0; 50.0; 100 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years |
60.0; 50.0; 50.0; 25.0; 90.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years |
60.0; 50.0; 30.0; 50.0; 60.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years |
40.0; 25.0; 20.0; 25.0; 40.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months |
0.0; 0.0; 10.0; 0.0; 30.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years |
0.0; 0; 10.0; 0.0; 30.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years |
20.0; 0.0; 10.0; 0.0; 20.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years |
0.0; 0.0; 0.0; 0.0; 20.0 | — |
| SECONDARY LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years |
— | — |
| SECONDARY LTE Study: Percent Change From Baseline in PASI Score at 18 Months |
-71.8; -60.5; -65.3; -50.0; -77.3 | — |
| SECONDARY LTE Study: Percent Change From Baseline in PASI Score at 2 Years |
-57.8; -64.5; -65.9; -46.0; -78.4 | — |
| SECONDARY LTE Study: Percent Change From Baseline in PASI Score at 3 Years |
-87.7; -69.0; -48.8; -48.0; -80.0 | — |
| SECONDARY LTE Study: Percent Change From Baseline in PASI Score at 4 Years |
-82.5; -52.0; -54.3; -80.0; -85.0 | — |
| SECONDARY Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4 |
— | — |
| SECONDARY LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months |
-71.1; -73.9; -74.2; -44.2; -76.7 | — |
| SECONDARY LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years |
-64.7; -66.2; -74.5; -24.7; -74.5 | — |
| SECONDARY LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years |
-86.1; -63.4; -58.4; -39.1; -78.5 | — |
| SECONDARY LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years |
-75.0; -50.6; -72.4; -75.0; -86.1 | — |
| SECONDARY LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months |
-78.6; -73.9; -73.3; -49.2; -86.4 | — |
| SECONDARY LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years |
-60.5; -66.2; -75.0; -41.5; -77.4 | — |
| SECONDARY LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years |
-85.7; -63.4; -60.9; -52.2; -81.0 | — |
| SECONDARY LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years |
-75.0; -50.6; -73.5; -75.0; -91.9 | — |
| SECONDARY LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months |
-6.5 | — |
| SECONDARY LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years |
-5.2; -13.5; -5.9; -1.8; -6.8 | — |
| SECONDARY LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years |
-11.7; -3.0; -4.2; -2.0; -6.0 | — |
| SECONDARY LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years |
-6.0; -9.0; -3.5; -7.0; -10.3 | — |
| SECONDARY LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months |
-2.8 | — |
| SECONDARY LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years |
5.0; 2.0; 5.2; 4.5; 0.2 | — |
| SECONDARY LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years |
6.0; -2.7; 3.6; 2.1; 2.4 | — |
| SECONDARY LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years |
-1.1; 4.1; -1.0; 17.6; 1.2 | — |
| SECONDARY LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months |
10.2 | — |
| SECONDARY LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years |
4.1; 3.7; 1.0; 2.4; 5.0 | — |
| SECONDARY LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years |
6.6; 1.0; -0.1; 4.4; 4.2 | — |
| SECONDARY LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years |
1.4; 2.0; -4.1; 10.2; 9.4 | — |
Eligibility Criteria
Inclusion Criteria
- Understand and voluntarily sign an informed consent form
- ≥18 years of age at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:
- PASI (Psoriasis Area and Severity Index) score ≥ 12
- Body Surface Area (BSA) ≥ 10%
- Candidate for photo/systemic therapy
- In good health as judged by the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis
- Meet all laboratory criteria as defined per protocol
- Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication
- Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication
Exclusion Criteria
- History of clinically significant disease (as determined by the investigator)
- Pregnant or breastfeeding
- History of active mycobacterial infection within 3 years
- History of Human Immunodeficiency Virus (HIV) infection
- Congenital and acquired immunodeficiencies
- Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
- Antibodies to Hepatitis C at screening
- Malignancy or history of malignancy except for treated [i.e., cured] basal-cell skin carcinomas
- Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Psoriasis flare within 4 weeks of screening
- Topical therapy within 2 weeks of randomization
- Systemic therapy for psoriasis within 4 weeks of randomization
- Use of phototherapy within 4 weeks of randomization [(i.e., Ultraviolet (UVB), Psoralens and long-wave ultraviolet radiation (PUVA)]
- Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization
- Alefacept within 24 weeks of randomization
- Investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)
- Prolonged sun exposure or use of tanning booths or other ultraviolet light sources
Data sourced from ClinicalTrials.gov (NCT00773734). 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. Informational only — not medical advice.