Phase 4
N=221
A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.
Parapsoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02425826 ↗Enrolled (actual)
221
Serious AEs
3.0%
Results posted
Jun 2017
Primary outcome: Primary: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 — -10.17; -48.07 percentage change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Apremilast (Drug); Placebo (Drug); Placebo-Apremilast (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 |
-10.17; -48.07 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 |
-2.4; -4.8 | 0.0008 sig |
| SECONDARY Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline |
9.6; 30.4 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline |
20.5; 33.8 | 0.0365 sig |
| SECONDARY Mean Change From Baseline in Pruritus Visual Analog Scale (VAS) |
-9.6; -13.9; -10.2; -19.2 | 0.0016 sig |
| SECONDARY Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician's Global Assessment (ScPGA) Scale at Week 16. |
38.2; 50.0 | 0.0463 sig |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16 |
38.81; 57.25; 75.00; 78.50; 65.68; 66.93 | <0.0001 sig |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52 |
57.68; 54.13; 77.29; 75.45; 72.74; 71.76 | — |
| SECONDARY Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16 |
-3.87; -40.72 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16. |
24.7; 53.4 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16 |
8.2; 21.6 | 0.0136 sig |
| SECONDARY Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52 |
-42.23; -55.45 | — |
| SECONDARY Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician's Global Assessment (ScPGA) Response From Week 16 to Week 52. |
50.0; 80.4 | — |
| SECONDARY Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase |
35; 92; 21; 71; 1; 3 | — |
| SECONDARY Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase |
142; 98; 5; 10; 1; 14 | — |
Summary
This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.
Eligibility Criteria
Inclusion Criteria
- Males or females, ≥ 18 years of age at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the informed consent.
- Have moderate plaque psoriasis at screening and baseline as defined by
- BSA (Body Surface Area)5% to 10% and
- sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale
- Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories.
- No prior exposure to systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis, or any other indication that could impact the assessment of psoriasis.
- Females of childbearing potential (FCBP)must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex 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.
- Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex 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
Exclusion Criteria
- Other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis.
- Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent.
- Malignancy or history of malignancy, except for:
- treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
- treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
- Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to randomization.
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer
Data sourced from ClinicalTrials.gov (NCT02425826). 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.