Phase 2
Completed N=254
Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
Psoriasis · Rheumatoid Arthritis · Psoriasis Arthropatica
Source: ClinicalTrials.gov NCT01988103 ↗
Enrolled (actual)
254
Serious AEs
3.4%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16 — 7.1; 23.5; 28.2 percentage of participants — p=0.0032
Summary
This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16 |
7.1; 23.5; 28.2 | 0.0032 sig |
| SECONDARY Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Point Reduction From Baseline to Week 16 |
8.8; 23.9; 29.6 | 0.0165 sig |
| SECONDARY Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) at Week 16 |
7.5; -21.6; -30.5 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score |
-3.7; -33.1; -43.1 | 0.0002 sig |
| SECONDARY Percentage of Participants Who Achieved a 50% Improvement From Baseline (Response) Reduction in the PASI-50 at Week 16 |
21.4; 41.2; 50.6 | 0.0057 sig |
| SECONDARY Change From Baseline in Pruritus Visual Analogue Scale 100-mm (VAS) at Week 16 |
7.1; -7.5; -17.7 | 0.0003 sig |
| SECONDARY Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 |
1.3; -0.5; -2.2 | 0.0204 sig |
| SECONDARY Change From Baseline in Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16 |
-1.59; -0.71; 0.27 | 0.5149 |
| SECONDARY Number of Participants Who Achieved an American College of Rheumatology Criteria (ACR) 20% Improvement (ACR 20) |
— | — |
| SECONDARY Percent Change From Baseline Psoriatic Arthritis Pain Visual Analogue Scale (VAS) |
— | — |
| SECONDARY Percent Change From Baseline in Physical Function Assessment Using the Health Assessment Questionnaire Disability Index (HAQ-DI) |
— | — |
| SECONDARY Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase |
35; 49; 44; 8; 18; 25 | — |
| SECONDARY Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period |
94; 89; 34; 37; 12; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female Japanese participants greater than or equal to 20 years of age.
- Diagnosis of chronic, stable plaque psoriasis for at least 6 months prior to screening as defined by: Psoriasis Area Severity Index (PASI) score ≥ 12 and BSA ≥ 10%.
- Psoriasis which is considered inappropriate for topical therapy (based on severity of disease and extent of affected area) or has not been adequately controlled or treated by topical therapy in spite of at least 4 weeks of prior therapy with at least one topical medication for psoriasis or per label.
- In otherwise good health based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis.
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 participant at unacceptable risk or confound the ability to interpret the data in the study.
Prior medical history of suicide attempt or major psychiatric illness requiring hospitalization within the last 3 years
- Pregnant or breastfeeding.
- History of or ongoing chronic or recurrent infectious disease.
- Active tuberculosis (TB) or a history of incompletely treated TB.
- Clinically significant abnormality on 12-lead ECG or on chest radiograph at screening.
- History of human immunodeficiency virus (HIV) infection or have congenital or acquired immunodeficiencies (eg, Common Variable Immunodeficiency).
- Hepatitis B surface antigen or hepatitis B core antibody positive at screening; positive for antibodies to hepatitis C at screening.
- Malignancy or history of malignancy, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas or treated (ie, cured) cervical intraepithelial neoplasia or carcinoma in situ (CIN) of the cervix with no evidence of recurrence within previous 5 years.
- Psoriasis flare within 4 weeks of screening.
- Topical therapy within 2 weeks prior to randomization or systemic therapy for psoriasis or psoriatic arthritis within 4 weeks prior to randomization.
- Use of etretinate within 2 years prior to randomization for females of child bearing potential (FCBP) or within 6 months for males, and within 4 weeks prior to randomization for non-FCBP.
- Use of phototherapy: Ultraviolet light B (UVB), Psoralens and long-wave ultraviolet radiation (PUVA) within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet light sources.
- Use of adalimumab, etanercept, certolizumab pegol, abatacept, tocilizumab, golimumab or infliximab within 12 weeks prior to randomization; use of ustekinumab, alefacept or briakinumab within 24 weeks prior to randomization.
- Any investigational drug within 4 weeks prior to randomization.
Data sourced from ClinicalTrials.gov (NCT01988103). 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.