Phase 3
N=595
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03721172 ↗Enrolled (actual)
595
Serious AEs
1.5%
Results posted
May 2021
Primary outcome: Primary: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase — 4.1; 21.6 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Apremilast (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase |
4.1; 21.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With a ≥ 75 Percent (%) Improvement From Baseline in Affected Body Surface Area (BSA) at Week 16 |
7.4; 33.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of Affected BSA at Week 16 |
-0.07; -3.45 | <0.0001 sig |
| SECONDARY Change From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 16 |
-0.54; -3.47 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved BSA ≤ 3% for Participants With Baseline Affected BSA > 3% at Week 16 |
22.9; 61.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With ≥ 4-point Reduction From Baseline in Whole Body Itch Numeric Rating Scale (NRS) Score at Week 16 Who Had Baseline Whole Body Itch NRS ≥ 4 |
18.6; 43.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Scalp Physician Global Assessment (ScPGA) Response at Week 16 Among Participants With Baseline scPGA Score ≥ 2 at Week 16 |
16.6; 44.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 |
-2.4; -5.2 | <0.0001 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
139; 195; 351; 2; 8; 24 | — |
Summary
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.
Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
Eligibility Criteria
Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the study:
- Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
- Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
- Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
- Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
- Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
- Subject must meet laboratory criteria.
- Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.
Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subjects has 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.
- Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
- Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
- Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
- Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.
- Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- Subject had prior treatment with apremilast.
Data sourced from ClinicalTrials.gov (NCT03721172). 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.