A Double-blind, Placebo-controlled, Randomized Study on the Safety and Efficacy of Apremilast in Patients With Moderate to Severe Plaque Psoriasis Involving Palms and/or Soles
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1
研究概览
简要总结
This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects with moderate to severe plaque psoriasis involving palms and/or soles.
Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared against placebo (dummy drug with no active ingredient).
This study will enroll approximately 100 adult subjects with moderate to severe plaque psoriasis involving palms and/or soles in approximately 20 centers in US and Canada. To be eligible, subjects must have moderate to severe plaque psoriasis involving palms or soles, with lesions covering at least 10% of the surface of palms and soles at the baseline visit. Study treatments will be assigned randomly (like flipping a coin) at a 1:1 ratio, meaning that there will be a 1 in 2 chance of either receiving Apremilast or placebo during the first 16 weeks. Subjects will not know which of the two treatments they receive. The study doctor, the study staff will not know which treatment they receive either. All subjects will receive Apremilast from Week 16 to Week 32.
Subjects will be asked to complete questionnaires about their hand and feet pain, their quality of life, their general health and the impact of psoriasis on their work.
Medical photographs of palms and soles will be taken for subjects at selected study sites only.
At Baseline and Week 16 visits, for willing subjects at certain study sites, skin biopsies can be taken. The biopsies will be analyzed for the presence of antibodies, antigens or certain cellular messengers that can be quantified. It is also possible to study the skin cellular structure and organization.
A total of 3 biopsies will be taken: At Baseline visit, one biopsy from psoriasis on palms or soles and one biopsy from normal skin of palms or soles will be collected. At Week 16 visit, only one biopsy from psoriasis on palms or soles will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, is aged 18 years or older at the screening visit.
- •Patient has a history of plaque psoriasis involving the palm(s) and/or sole(s) for at least 6 month(s).
- •Patient has moderate to severe psoriasis with a PPPGA of at least 3 and with at least 10% of the total surface of palms and soles (PPPSA) affected by psoriatic plaques at baseline.
排除标准
- •Female patient is pregnant or breastfeeding
- •Patient has the presence of pustules on palms or soles at screening or baseline
- •Patient who has used any topical treatment for psoriasis (except non-medicated emollients) in the last 14 days before Day 0 with the exception of hydrocortisone and desonide for the face, groin (including genitals) and inframammary areas as well as shampoos containing tar, salicylic acid or zinc pyrithione if they are applied with gloves.
- •Patient who has used ultraviolet B (UVB) phototherapy or excessive sun exposure less than 28 days before Day
- •Patient has used any non-biological systemic therapy for the treatment of psoriasis (including psoralens ultraviolet A (PUVA)) therapy, methotrexate, acitretin and cyclosporin), systemic steroids or systemic immunosuppressants less than 28 days before Day
- •Use of any investigational agents within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- •Prior treatment with apremilast
- •Patient is currently participating in a clinical trial with an experimental agent or device.
- •Patient is using or has used any biological therapy for the treatment of psoriasis. Exceptions to this criterion are: patients who used no more than one biologic in the past and stopped for reasons other than lack of efficacy are eligible.
- •Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed. Patients who have used oral or injectable corticosteroids less than 28 days before Day 0 are excluded.
- •Patient is known to have immune deficiency or is immunocompromised or currently uses or plans to use anti-retroviral therapy at any time during the study.
- •Active tuberculosis or history of inadequately treated tuberculosis
- •Other than psoriasis, patient has 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.
- •Other than psoriasis, patient has any other dermatological condition that could, in the opinion of the investigator, interfere with the study assessments.
- •Any condition, including the presence of laboratory abnormalities (including estimated creatinine clearance of less than 30 mL per minute), which would place the patient at unacceptable risk if he/she were to participate in the study.
- •Malignancy or history of malignancy, except for:
- •treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- •treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.
- •Known hypersensitivity to apremilast or any excipients in formulation.
- •Patient has the following hereditary disease: galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Use of strong cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin)
- •Active substance abuse or a history of substance abuse within 6 months prior to Screening.
- •Prior history of suicide attempt at any time in the patient's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- •Presence of uncontrolled depression.
研究组 & 干预措施
Apremilast
Patients will receive Apremilast until week 32.
干预措施: Apremilast (Drug)
Placebo followed by Apremilast
Patients will receive Placebo until week 16 and then receive Apremilast until week 32
干预措施: Apremilast (Drug)
Placebo followed by Apremilast
Patients will receive Placebo until week 16 and then receive Apremilast until week 32
干预措施: Placebo (Drug)
结局指标
主要结局
Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1
时间窗: 16 weeks
Number of patients who achieve a PPPGA of 0 or 1 at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo The PPPGA is a zero to five, 6-point scale that evaluates the severity of palmoplantar psoriasis (score 0 \[Clear\]; score 1 \[Almost clear\]; score 2 \[Mild\]; score 3 \[Moderate\]; score 4 \[Severe\]; score 5 \[Very severe\]).
次要结局
- Palmoplantar Psoriasis Surface Area (PPPSA)(16 weeks)
- Palmoplantar Psoriasis Area Severity Index (PPPASI)(32 weeks)
- Palmoplantar Psoriasis Physician Global Assessment (PPPGA)(16 weeks)
- Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1(32 weeks)