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
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 Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
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 AUR101 (RORgamma inhibitor) in patients with moderate-to-severe psoriasis.
Approximately 90 patients with chronic moderate-to-severe plaque psoriasis will be randomized to the 2 dose groups of AUR101 and one group of Placebo. The patients will receive the treatment for 12 weeks.
详细描述
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.
Every patient will receive 12 weeks of treatment. 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
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 or anti-TNF agents) for the treatment of psoriasis.
- •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 within 6 months prior to study day 1
- •Current treatment or history of treatment for psoriasis with other biological agents within 3 months prior to study day
- •Current treatment or history of treatment for psoriasis with non-biological systemic medications or phototherapy within 4 weeks prior to study day
- •Treatment with medicated topical agents within 2 weeks prior to study day
- •History or presence of any medical or psychiatric disease, or clinically significant laboratory at screening,
- •Evidence of organ dysfunction
- •Any major recent surgery history within 3 months prior to screening
- •Alcohol abuse or drug abuse
- •History of malignancy
- •Positive for HIV, Hepatitis B or Hepatitis C at screening.
- •Patient with known past history of systemic tuberculosis or currently suspected or known to have tuberculosis
- •Patient expected to be started on anti-tubercular therapy either for treatment or prophylaxis of tuberculosis.
- •Suspected tuberculosis infection as evident from a positive QuantiFERON TBGold test (QFT) at screening. Patients with a positive QFT test may participate in the study if further work up as per the opinion of the investigator .
- •History of hypersensitivity or idiosyncratic reaction to any investigational RORgamma inhibitors or any of the excipients of study drug
- •Past gastrointestinal surgery or recent (within 3 months) / current history of gastrointestinal disease.
- •Positive pregnancy test for women of child bearing potential (WOCBP) at the screening or randomization visit
- •Male patients with partners of childbearing potential not willing to use reliable contraception methods.
- •Pregnant or lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods
- •Has received another new chemical entity/investigational drug within 28 days or 5 half-lives of investigational drug prior to study day
- •Use of herbal remedies, mega dose vitamins and minerals during the 2 weeks prior to the first administration of investigational product.
- •Patients who have received live or attenuated vaccine in the 4 weeks prior to study day 1.
研究组 & 干预措施
Arm-1 400 mg BID
400 mg AUR101 twice daily
干预措施: AUR101 (Drug)
Arm-2 600 mg BID
600 mg AUR101 twice daily
干预措施: AUR101 (Drug)
Arm-3 - Matching Placebo BID
Matching Placebo twice daily
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
时间窗: week 12
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. Regulators commonly accept PASI 75 for measuring primary response of psoriasis in patients with Psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline
次要结局
- Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))(Week 4 and Week 8 from study drug initiation for these secondary outcomes measures)
- Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1(Week 4, Week 8 and Week 12)
- Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 50 (i.e. 50% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))(Week 4, Week 8 and Week 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI)(Week 4,8 and 12)
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.(week 4,8 and 12)
- Change From Baseline in Investigator Global Assessment (IGA) Scale(week 4,8 and 12)
- Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved(week 4,8 and 12)