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临床试验/NCT03591887
NCT03591887已完成2 期

A Phase II, Randomized, Parallel Group, Placebo-controlled, Double-blinded, Dose-finding Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis

Affibody36 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2018年3月7日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
108
试验地点
36
主要终点
Proportion of subjects with a ≥90% improvement in Psoriasis Area and Severity Index (PASI90) at week 12
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized, double-blinded dose-finding study evaluates four dose levels of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis.

The study consists of 52-week Core study and two optional 52-week periods, Extension and Prolongation of Extension.

The Core study consists of three periods: Induction (placebo-controlled, Week 0-12), Optimization (Week 12-24), and Individualization (Week 24-52).

详细描述

The Core study evaluates four doses of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis. The treatment periods in the Core study are:

  • Induction (Week 0-12) - four dose levels and placebo (Q2W)
  • Optimization (Week 12-24) - starting with a possible dose adjustment (all subjects on Q2W) depending on PASI score. Subjects on placebo switch to active drug (Q4W).
  • Individualization (Week 24-52) - starting with a switch to Q4W for all subjects. From week 32 dosing interval alters depending on PASI score.

The study is unblinded after completion of the Core study. During the optional Extension and Prolongation of Extension periods, dose levels and intervals alter depending on PASI score.

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

  • •Diagnosed with plaque psoriasis of at least 6 months prior to Screening, without clinically significant flares during the 12 weeks before randomization, with or without psoriatic arthritis
  • •Having precedent failure, intolerance and/or contraindication to at least two standard therapies for moderate to-severe plaque psoriasis (systemic therapy and/or phototherapy), and previousinsufficient disease control of topical therapy (e.g. corticosteroids, vitamin D derivatives, cignolin/dithranol).
  • •Moderate-to-severe plaque psoriasis at Screening and at Baseline as defined by:
  • •i. Psoriasis involving ≥10% BSA ii. PASI score of ≥ 12 iii. sPGA score of ≥ 3
  • •Use of highly effective method of contraception or female of non-childbearing potential

排除标准

  • •Current forms of psoriasis other than chronic plaque-type
  • •Current drug induced psoriasis
  • •History of hypersensitivity or allergy to the IMP or its excipients
  • •History of recurrent or medically important infections requiring intervention and/or systemic treatment in the last 12 months, including infections with e.g. candida and Staphylococcus aureus
  • •History of or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years (with the exception of basal cell or squamous cell carcinoma of the skin that had been fully excised with no evidence of recurrence)
  • •Autoimmune disease of relevance
  • •Inflammatory Bowel Disease requiring treatment within the past 12 months
  • •Clinically significant heart condition which is not well controlled by current therapy, as assessed by the Investigator
  • •Significantly immunocompromised subject
  • •Blood pressure out of range
  • •Laboratory values out of range, including ALT, AST, eGFR
  • •Positive to HIV, hepatitis B, hepatitis C or tuberculosis
  • •Recent previous psoriasis treatments, within defined wash-out periods
  • •Prior exposure to systemic psoriasis treatments with anti-IL-17 biological therapies
  • •Live vaccination within defined time restrictions
  • •Inability or unwillingness to limit ultraviolet (UV) light exposure during the course of the study
  • •Pregnancy, breast feeding
  • •Drug and/or alcohol abuse or dependence

结局指标

主要结局

Proportion of subjects with a ≥90% improvement in Psoriasis Area and Severity Index (PASI90) at week 12

时间窗: 12 weeks

The PASI combines the extent of body surface involvement in the body regions head, trunk, arms, and legs. The percent area of the skin involved is estimated per region (0-100%). The severity is estimated by clinical signs of erythema, induration and scaling, from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). PASI90 is a ≥90% reduction from Baseline in PASI score

次要结局

  • Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 24(24 weeks)
  • Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 52(52 weeks)
  • Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 12(12 weeks)
  • Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 12(12 weeks)
  • Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 24(24 weeks)
  • Proportion of subjects achieving an absolute PASI score ≤1 at week 24(24 weeks)
  • Proportion of subjects achieving an absolute PASI score ≤1 at week 12(12 weeks)
  • Number of treatment emergent Adverse Events(52 weeks)
  • Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 24(24 weeks)
  • Change from baseline in PASI score at week 24(Week 24)
  • Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 52(52 weeks)
  • Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 24(24 weeks)
  • Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 52(52 weeks)
  • Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 12(12 weeks)
  • Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 52(52 weeks)
  • Change from baseline in PASI score at week 12(Week 12)
  • Change from baseline in PASI score at week 52(Week 52)
  • Proportion of subjects achieving an absolute PASI score ≤1 at week 52(52 weeks)
  • Proportion of subjects achieving an absolute PASI score <3 at week 24(24 weeks)
  • Proportion of subjects achieving an absolute PASI score <3 at week 12(12 weeks)
  • Proportion of subjects achieving an absolute PASI score <3 at week 52(52 weeks)
  • Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 12(12 weeks)
  • Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 24(24 weeks)
  • Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 52(52 weeks)
  • Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 12(12 weeks)
  • Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 24(24 weeks)
  • Change from baseline in sPGA at week 24(24 weeks)
  • Change from baseline in sPGA at week 52(52 weeks)
  • Change from baseline in target nail Nail Psoriasis Severity Index (NAPSI) at week 12(Week 12)
  • Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 52(52 weeks)
  • Change from baseline in sPGA at week 12(12 weeks)
  • Change from baseline in target nail NAPSI at week 24(Week 24)
  • Proportion of subjects achieving Dermatology Life Quality Index (DLQI) of 0 or 1 at week 12(Week 12)
  • Proportion of subjects achieving DLQI of 0 or 1 at week 24(Week 24)
  • Proportion of subjects achieving DLQI of 0 or 1 at week 52(Week 52)
  • Change from baseline in target nail NAPSI at week 52(Week 52)
  • Proportion of subjects achieving DLQI of ≤ 5 at Week 12(Week 12)
  • Proportion of subjects achieving DLQI of ≤ 5 at Week 24(Week 24)
  • Proportion of subjects achieving DLQI of ≤ 5 at Week 52(Week 52)
  • Change from baseline in DLQI at week 12(Week 12)
  • DLQI at week 52 compared to baseline(Week 52)
  • Change from baseline in pain-Visual Analogue Scale (VAS) at week 12(Week 12)
  • Pain-VAS score at Week 24 compared to baseline(Week 24)
  • Change from baseline in itch-Visual Analogue Scale (VAS) at week 12(Week 12)
  • Pharmacokinetics: Area Under the Curve (AUC) of ABY-035 during the Extension period(Week 52 to Week 104)
  • DLQI at week 24 compared to baseline(Week 24)
  • Pain-VAS score at Week 52 compared to baseline(Week 52)
  • Itch-VAS at week 24 compared to baseline(Week 24)
  • Number of treatment emerging Adverse Events during the Prolongation of Extension period(Week 104 to Week 156)
  • Itch-VAS at week 52 compared to baseline(Week 52)
  • Levels of anti-ABY-035 antibodies in serum(52 weeks)
  • Number of treatment emerging Adverse Events during the Extension period(Week 52 to Week 104)
  • Pharmacokinetics: Area Under the Curve (AUC) of ABY-035 during the Prolongation of Extension period(Week 104 to Week 156)
  • Levels of anti-ABY-035 antibodies in serum during the Extension period(Week 52 to Week 104)
  • Pharmacokinetics: Area Under the Curve (AUC) of ABY-035(52 weeks)
  • Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at end of Prolongation of Extension period(Week 156)
  • Levels of anti-ABY-035 antibodies in serum during the Prolongation of Extension period(Week 104 to Week 156)
  • Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at end of Extension period(Week 104)
  • Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at end of Extension period(Week 104)
  • Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at end of Prolongation of Extension period(Week 156)
  • Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at end of Extension period(Week 104)
  • Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at end of Prolongation of Extension period(Week 156)
  • Proportion of subjects achieving a 100% improvement in PASI (PASI100) at end of Extension period(Week 104)
  • Proportion of subjects achieving a 100% improvement in PASI (PASI100) at end of Prolongation of Extension period(Week 156)
  • Proportion of subjects achieving an absolute PASI score <3 at end of Extension period(Week 104)
  • Proportion of subjects achieving an absolute PASI score <3 at end of Prolongation of Extension period(Week 156)
  • Change from baseline in PASI score at end of Extension period(Week 104)
  • Change from baseline in PASI score at end of Prolongation of Extension period(Week 156)
  • Proportion of subjects achieving an absolute PASI score ≤1 at end of Extension period(Week 104)
  • Proportion of subjects achieving sPGA of 0 or 1 at end of Prolongation of Extension period(Week 156)
  • Change from baseline in sPGA at end of Extension period(Week 104)
  • Pain-VAS score at end of Extension period compared to baseline(Week 104)
  • Proportion of subjects achieving an absolute PASI score ≤1 at end of Prolongation of Extension period(Week 156)
  • Proportion of subjects achieving sPGA of 0 or 1 at end of Extension period(Week 104)
  • Change from baseline in sPGA at end of Prolongation Extension period(Week 156)
  • Change from baseline in target nail NAPSI at end of Prolongation of Extension period(Week 156)
  • Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at end of Extension period(Week 104)
  • Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at end of Prolongation of Extension period(Week 156)
  • Change from baseline in target nail NAPSI at end of Extension period(Week 104)
  • Proportion of subjects achieving DLQI of 0 or 1 at end of Extension period(Week 104)
  • Proportion of subjects achieving DLQI of 0 or 1 at end of Prolongation of Extension period(Week 156)
  • Proportion of subjects achieving DLQI of ≤ 5 at end of Extension period(Week 104)
  • Proportion of subjects achieving DLQI of ≤ 5 at end of Prolongation of Extension period(Week 156)
  • DLQI at end of Extension period compared to baseline(Week 104)
  • Pain-VAS at end of Prolongation of Extension period compared to baseline(Week 156)
  • DLQI at end of Prolongation of Extension period compared to baseline(Week 156)
  • Itch-VAS at end of Extension period compared to baseline(Week 104)
  • Itch-VAS at end of Prolongation of Extension period compared to baseline(Week 156)

研究者

发起方
Affibody
申办方类型
Industry
责任方
Sponsor

研究点 (36)

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