A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Efficacy and Safety of ME3183 Administered Orally in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 27
- 主要终点
- Percentage of Participants Achieving Greater Than or Equal to (>=) 75% Reduction From Baseline in Psoriasis Area Severity Index (PASI) Score (PASI-75) at Week 16
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, ages 18 to 75 years
- •Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.
排除标准
- •Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
- •Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening.
- •Hepatitis B surface antigen positive at Screening.
- •History of HIV or Positive for the HIV antibodies at Screening.
- •History of allergy to any component of the study treatment.
- •Active tuberculosis (TB) or a history of incompletely treated TB.
- •Active infection (bacteria, viral, fungal, etc.) requiring treatment with systemic antibiotics within 4 weeks of Screening.
- •Malignancy or history of malignancy except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence.
- •Pregnant or breast feeding
- •Received ustekinumab, secukinumab, brodalumab, ixekizumab, guselkumab, risankizumab, tildrakizumab, or briakinumab within 24 weeks of first administration of study treatment.
- •Received TNF-α inhibitor(s)/blocker(s) within 8 weeks of first administration of study treatment.
- •Received rituximab within 24 weeks of first administration of study treatment.
- •Received phototherapy or any systemic medications/treatments within 4 weeks of the first administration of study treatment.
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
ME3183 Dose 1, BID
Specified dose of ME3183 capsule for 16 weeks
干预措施: ME3183 (Drug)
ME3183 Dose 2, QD
Specified dose of ME3183 capsule for 16 weeks
干预措施: ME3183 (Drug)
ME3183 Dose 3, BID
Specified dose of ME3183 capsule for 16 weeks
干预措施: ME3183 (Drug)
ME3183 Dose 4, QD
Specified dose of ME3183 capsule for 16 weeks
干预措施: ME3183 (Drug)
Placebo
Placebo capsule of ME3183 for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Greater Than or Equal to (>=) 75% Reduction From Baseline in Psoriasis Area Severity Index (PASI) Score (PASI-75) at Week 16
时间窗: Week 16
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over the 16-week Treatment Period and the 4-week Follow-up Period(Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20))
- Number of Participants With Clinically Significant Abnormalities in Physical Examination(Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20))
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20))
- Trough Serum Concentration (Ctrough) of ME3183(Pre-dose at Week 1, 4, 8 and 16)
- Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period(Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20))
- Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Number of Participants With Serious TEAEs Over the 16-week Treatment Period and the 4-week Follow-up Period(Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20))
- Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Time to PASI-50(Baseline to Week 16)
- Time to PASI-75(Baseline to Week 16)
- Percentage of Participants Achieving a Static Physicians Global Assessment (sPGA) Score of "0" ("Clear") or "1" ("Almost Clear") Combined With 2-point Reduction on the 5-point sPGA Scale at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests(Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20))
- Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16(Baseline, Week 1, 2, 4, 8, 12 and 16)
- Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16(Baseline, 1, 2, 4, 8, 12 and 16)