NCT03930186已完成3 期
A Phase 3b, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 152
- 试验地点
- 29
- 主要终点
- Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16
研究概览
简要总结
The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.
详细描述
Participants will be enrolled at 28 sites in Japan. The study consists of 4 phases: a screening phase (4 weeks), an open-label combination therapy phase (16 weeks), an open-label combination therapy phase with optional topical reduction (16 weeks), and a post-treatment observational follow-up phase (4 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF) with plaque psoriasis.
- •Subject has understood and voluntarily signed an informed consent document prior to any study related assessments/procedures being conducted.
- •Subject is able to adhere to the study visit schedule and other protocol requirements.
- •Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior to Baseline.
- •Subject has psoriasis with sPGA = 2 or 3 at screening and baseline.
- •Subject is currently treated for psoriasis with topical therapies only for at least 4 weeks prior to Baseline.
- •Subject has inadequate response to current topical therapy as per Investigator's discretion.
- •Subject is naïve to all biologic therapies for psoriasis vulgaris.
- •Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories.
- •(NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- •Subjects that are females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- •Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •Subject has any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, pustular, inverse, erythrodermic, or guttate), other than plaque psoriasis.
- •Subject has psoriatic arthritis that requires systemic therapy.
- •Subject has history of drug-induced psoriasis.
- •Subject has had prior treatment with biologic therapies for psoriasis.
- •Subject has used phototherapy or conventional systemic therapy for psoriasis within 8 weeks prior to baseline and during the study (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine).
- •Subject has worsening of psoriasis indicated by an increase in sPGA of ≥ 1 from Screening to Baseline.
- •Subject cannot avoid excessive sun exposure or use of tanning booths for at least 8 weeks prior to Baseline and during the study.
- •Subject is currently enrolled in any other clinical trial involving an investigational product.
- •Subject has other than psoriasis, 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.
- •Subject has malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas.
- •Subject has received a live vaccine within 3 months of baseline or plans to do so during study.
- •Subject is pregnant or breastfeeding (lactating) women.
- •Subject has bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening and no new or recurrent infections prior to the Baseline Visit.
- •Subject is hepatitis B surface antigen positive or hepatitis B core antibody positive at screening.
- •Subject is positive for antibodies to hepatitis C at screening.
- •Subject 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 prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and enrollment, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
- •Subject has active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent.
- •Subject has prior treatment with apremilast or participation in a clinical study involving apremilast.
研究组 & 干预措施
Apremilast
Experimental
After a 5-day titration, participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16 participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
干预措施: Apremilast (Drug)
Apremilast
Experimental
After a 5-day titration, participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16 participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
干预措施: Topical Therapy (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16
时间窗: Week 16
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe. The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets.
次要结局
- Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32(Baseline and weeks 2, 16, and 32)
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32(Baseline and weeks 16 and 32)
- Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75)(Weeks 16 and 32)
- Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32(Week 32)
- Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32(Weeks 16 and 32)
- Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32(Baseline and weeks 16 and 32)
- Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline(Weeks 16 and 32)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32(Baseline and weeks 16 and 32)
- Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50)(Weeks 16 and 32)
- Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32(Weeks 16 and 32)
- Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32(Baseline and weeks 2, 16, and 32)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores(Baseline and weeks 16 and 32)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From first dose of study drug until at least 28 days after last dose; up to 36 weeks.)
研究者
研究点 (29)
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