Phase 3
Completed N=250
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
Source: ClinicalTrials.gov NCT01690299 ↗Enrolled (actual)
250
Serious AEs
4.1%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline — 11.9; 39.8 Percentage of participants — p=< 0.0001
Summary
This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline |
11.9; 39.8 | < 0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16 |
11.9; 48.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 |
3.6; 21.7; 28.9 | 0.0005 sig |
| SECONDARY Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 |
-16.3; -47.7; -56.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 |
33.3; 62.7; 83.1 | 0.0002 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 |
-3.9; -8.4; -7.8 | <0.0001 sig |
| SECONDARY Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 |
2.6; 3.5; 4.8 | 0.7112 |
| SECONDARY Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 |
6.0; 24.1; 22.9 | 0.0011 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase |
45; 59; 44; 17; 27; 21 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period |
45; 71; 54; 23; 36; 15 | — |
| SECONDARY Psoriasis Flare/Rebound |
1; 4; 0; 1; 2; 7 | — |
| SECONDARY Psoriasis Flare/Rebound |
1; 4; 0; 1; 2; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females, ≥ 18 years of age
- Diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior to Screening, and a candidate for phototherapy and/or systemic (including etanercept) therapy
- Had an inadequate response, intolerance, or contraindication to at least 1 conventional systemic agent for the treatment of psoriasis.
- No prior exposure to biologics for treatment of psoriatic arthritis or psoriasis
Exclusion Criteria
- Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; 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.
- Pregnant or breast feeding.
- Have failed more than 3 systemic agents for treatment of psoriasis.
- History of allergy to any component of the investigational product (IP), including human immunoglobulin (Ig) proteins or allergy to etanercept.
- Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
- Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, Clostridium difficile).
- Have a history of, or ongoing, chronic or recurrent infectious disease
- Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before first administration of IP, or through Week 20 during the study.
- Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.
- History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
- Malignancy or history of malignancy, except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.
- Psoriasis flare or rebound within 4 weeks prior to Screening.
- Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis within 4 weeks prior to randomization
- Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
- Any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Prior treatment with apremilast or etanercept.
Data sourced from ClinicalTrials.gov (NCT01690299). 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.