An investigator initiated, open label, randomized, prospective, comparative, three arm clinical trial to evaluate the safety and effectiveness of Apremilast with three different titration methods in patients with chronic plaque psoriasis.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1.The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs
研究概览
简要总结
| Psoriasis is a chronic immune-mediated disease that affects up to 2% of the population worldwide, and is associated with several co-morbidities including metabolic syndrome, cardiovascular disease, and psychiatric disorders with an overall impairment of a patient’s quality of life. Psoriasis treatment primarily depends on disease severity, but also on co-morbidities, concomitant medications, previous therapies, adverse reactions etc. |
Mild-to-moderate psoriasis is usually treated with topical treatments such as topical corticosteroids etc. and phototherapy, while systemic agents (non-biologic and biologic) are used for moderate-to-severe skin disease. These therapies can be used either as monotherapy or in combinations. Conventional systemic therapy (methotrexate, cyclosporine, and acitretin) and phototherapy are usually used as first-line therapies for moderate-to-severe psoriasis. However, the long-term continuous use of conventional systemic treatments is not recommended because of their potential organ toxicity, which frequently leads to treatment discontinuation or is a reason for contraindication.
Apremilast is a systemic therapy indicated for the treatment of moderate to severe psoriasis in adults who are candidates for systemic medication or phototherapy and for active psoriatic arthritis that is not completely responsive to disease-modifying anti-rheumatic drugs (DMARDs). This phosphodiesterase 4 (PDE-4) inhibitor interrupts an early point of the inflammatory cascade: by blocking degradation of cyclic adenosine monophosphate (cAMP), intracellular levels of cAMP increase and antagonize the production of several pro-inflammatory cytokines, including tumor necrosis factor (TNF)–α and interleukin (IL)– 23 and IL-17.
Overall, in clinical trials, Apremilast was mostly well tolerated, and AEs were mostly mild to moderate in severity in all the study periods (short and long term). The most frequent AEs were diarrhea (17.8%), nausea (16.6%), and upper respiratory tract infections (8.4%). Tension headache, headache, nasopharyngitis, and upper respiratory infection were also reported frequently. These side effects are linked to cAMP levels which are decreased in psoriasis. Because of higher incidence of gastrointestinal adverse events dose titration of Apremilast is recommended at the start of therapy for a period of 1 week. However, despite the initial dose titration many patients develop diarrhea and nausea leading to discontinuation of therapy and poor compliance. To overcome this issue many dermatologists, use multiple different dose titration methods like slow titration over a period of 2 weeks, etc. at the start of therapy to increase the compliance of patient to the therapy.
Keeping this scenario in mind, we are conducting this study to evaluate the safety and effectiveness of different dose titration methods of Apremilast in management of patients with plaque psoriasis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Both male and female patients aged ≥ 18 years and ≤ 65 years.
- •2.Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
- •3.Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
- •4.Patients who the study staff deems reliable and mentally competent to carry out the study.
排除标准
- •1.Pregnant or nursing females.
- •2.Patients with known hypersensitivity to the study drugs.
- •3.Patients with immunosuppressive disease.
- •4.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
- •5.Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
- •6.History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •7.Currently enrolled in another clinical study or used any investigational drug or device within 28 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
- •8.Any patient whom the investigator judged to be inappropriate for this study.
结局指标
主要结局
1.The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs
时间窗: Week 16
2.Number of patients who prematurely discontinued Apremilast due to adverse event
时间窗: Week 16
次要结局
- 5.Change in erythema from baseline.(6.Change in dryness of from baseline.)
- 1.Change in dryness of from baseline.(2.Change in scaling from baseline.)
- 1.Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline.(2.Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline.)