CTRI/2020/01/022728已完成2 期
A Phase II, Multicenter, Double-blind, Double-dummy, Placebo controlled, Randomized, Study to Evaluate the Efficacy and Safety of two doses of AUR101 in patients with Moderate-to-Severe Psoriasis
Aurigene Discovery Technologies Limited Subsidiary of Dr Reddys Laboratories Limited9 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年1月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 9
- 主要终点
- Proportion of patients achieving PASI 75 response (i.e. 75% reduction from
研究概览
简要总结
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of two doses of AUR101 in patients
with moderate-to-severe psoriasis.
Approximately 90 patients with chronic moderate-to-severe plaque psoriasis (defined as Psoriasis Area and Severity Index (PASI) ≥12 and Body Surface
Area (BSA) involved ≥10%) will be randomized to the 2 dose groups of AUR101 and placebo in the ratio of 1:1:1.
The patients in each arm will receive AUR101 of 400 mg twice daily or AUR101 600 mg twice daily or matching placebo twice daily for 12 weeks in a double blind, double dummy fashion. All the patients will be followed up for 14 ± 2 days of their last dose for safety assessment.
A subset of approximately 25 patients, who consent, will be asked to come for plasma PK assessment in week 4 of dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months before screening
- •Psoriasis of at least moderate severity, defined as PASI≥12 and involved BSA≥10 % at screening and Day 1
- •Adult males or females, ≥ 18 to ≤ 65 years of age,
- •Ability to communicate well with the investigator and to comply with the requirements of the entire study
- •Willingness to give written informed consent (prior to any study related procedures being performed) and ability to adhere to the study restrictions and assessments schedule.
排除标准
- •History of erythrodermic, guttate, or pustular psoriasis within last 12 months
- •Efficacy failure on any biologic (e.g. interleukin (IL)-17 antibodies like brodalumab or ixekizumab or anti-TNF agents like etanercept, infliximab or adalimumab) for the treatment of psoriasis Note: Efficacy failure is defined as: A) Failure to achieve static Physician/ Investigator Global Assessment (PGA/IGA) of 0 to 2 (i.e. clear to mild) despite a continuous treatment with biologic at the approved (as in package insert) dose for at least 8 weeks And / Or B) After having an efficacious response, PGA/IGA increased to 3 or higher while receiving the approved (as in package insert) dose as maintenance
- •Static 5-point IGA mod 2011 scale of 0 to 2 at screening or Day
- •BMI ≥ 35 kg/m2
- •Current treatment or history of treatment for psoriasis with IL-17 or IL-12/23 antagonist biological agents (e.g. secukinumab, briakinumab, tildrakizumab, ustekinumab etc.) within 6 months prior to study day 1
- •Current treatment or history of treatment for psoriasis with other biological agents (e.g. adalimumab, etanercept, infliximab, alefacept etc.) within 3 months prior to study day 1
- •Current treatment or history of treatment for psoriasis with non-biological systemic medications (including systemic steroids, methotrexate, cyclosporine etc.) or phototherapy within 4 weeks prior to study day
- •Treatment with medicated topical agents (having active pharmaceutical ingredient that can impact the interfere with effect of the study drug; See Section 8.11 of protocol) within 2 weeks prior to study day
- •History or presence of any medical or psychiatric disease, or clinically significant laboratory.
结局指标
主要结局
Proportion of patients achieving PASI 75 response (i.e. 75% reduction from
时间窗: At the end of week 12.
baseline PASI score)
时间窗: At the end of week 12.
次要结局
- Proportion of patients achieving PASI 75 response (i.e. 75% reduction from(baseline PASI score))
- Proportion of patients achieving PASI 50 response (i.e. 50% reduction from(baseline PASI score))
- Proportion of patients achieving IGA 0 or 1(At week 4, 8 and 12)
- Percent change from baseline in PASI score(At week 4, 8 and 12)
- Change from baseline in IGA scale(At week 4, 8 and 12)
- Change from baseline to week 4, 8 and 12 in percent Body Surface Area (BSA) involved(At week 4, 8 and 12)
- Change from baseline to week 4, 8 and 12 in Dermatology Life Quality Index((DLQI))
研究者
研究点 (9)
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