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临床试验/NCT05131477
NCT05131477已完成2 期

A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis

Kymab Limited101 个研究点 分布在 7 个国家目标入组 390 人开始时间: 2021年12月13日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
Kymab Limited
入组人数
390
试验地点
101
主要终点
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)
研究概览研究设计入排标准研究组 & 干预措施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 is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.

The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.

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

  • •Adults (18 to < 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.
  • •Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
  • •Investigator's Global Assessment (IGA) Scale of 3 or 4 at Baseline.
  • •AD involvement of 10% or more of body surface area (BSA) at Baseline.
  • •Baseline worst/maximum pruritus Numeric Rating Scale (NRS) of ≥
  • •Documented history, within 6 months prior to Baseline, of either inadequate response or inadvisability of topical treatments.
  • •Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline.
  • •Able to complete patient questionnaires.
  • •Able and willing to comply with requested study visits/telephone visits and procedures.
  • •Able and willing to provide written informed consent.
  • •For patients who decide to join the biopsy sub-study be able and willing to provide skin biopsies.

排除标准

  • •Treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.
  • •Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
  • •Weight <40 kg or >150 kg at Baseline.
  • •Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline.
  • •Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
  • •Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and cured for more than 3 years prior to Baseline; in situ cervical carcinoma that has been excised and cured).
  • •Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
  • •Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
  • •In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology or urinalysis tests at the Screening Visit.
  • •Concurrent participation in any other clinical study, including non-interventional studies.
  • •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

研究组 & 干预措施

250mg (500mg Loading Dose) KY1005

Experimental

Every 4 weeks

干预措施: Amlitelimab (Drug)

250mg (No Loading Dose) KY1005

Experimental

Every 4 weeks

干预措施: Amlitelimab (Drug)

125mg KY1005

Experimental

Every 4 weeks

干预措施: Amlitelimab (Drug)

62.5mg KY1005

Experimental

Every 4 weeks

干预措施: Amlitelimab (Drug)

Placebo

Placebo Comparator

Every 4 weeks

干预措施: Placebo (Drug)

结局指标

主要结局

Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)

时间窗: Baseline to week 16

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

次要结局

  • Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)(Baseline to week 16 and week 24)
  • Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)(Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52)
  • Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)(Baseline to weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)(Baseline to weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)(Baseline to weeks 4, 8, 12, 16, 20, & 24)
  • Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52)
  • Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)(Baseline to weeks 2, 4, 8, 12, 16, 20, & 24)
  • Percentage Change in Affected BSA From Baseline (Part 1)(Baseline to weeks 2, 4, 8, 12, 16, 20, & 24)
  • Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)(Baseline to weeks 2, 8, 16, 20, & 24)
  • Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52)
  • Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)(Baseline to weeks 16, & 24)
  • Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)(Baseline to weeks 16, & 24)
  • Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)(Baseline to weeks 24, 36 & 52)
  • Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)(Baseline to weeks 8, 16, 20, & 24)
  • Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52)
  • Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)(Baseline to week 24)
  • Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)(Baseline to week 16 and week 24)
  • Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)(Baseline to week 16 and week 24)
  • Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52)
  • Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)(Baseline at weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage Change in Affected BSA From Baseline (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52)
  • Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)(Baseline to weeks 4, 8, 12, 16, 20, & 24)
  • Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)(Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52)
  • Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)(Baseline to weeks 2,4, 8,12,16, 20 and 24)
  • Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)(Baseline to weeks 2, 4, 8, 12, 16, 20 and 24)
  • Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)(Baseline to weeks 2, 4, 8, 12, 16, 20, & 24)
  • Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)(Baseline to weeks 2, 4, 8,12,16,20 & 24)
  • Absolute Change in Affected BSA From Baseline (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52)
  • Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)(Baseline to weeks 24, 32, 36, 40. 44, 48, & 52)
  • Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52)
  • Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)(Baseline to weeks 2, 4, 8, 12, 16, 20 and 24)
  • Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)(Baseline to weeks 4, 8, 12, 16, 20 & 24)
  • Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)(Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52)
  • Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)(Baseline to weeks 24, 32, 36, 40, 44, 48 & 52)
  • Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)(Baseline to weeks 4, 8, 12, 16, 20, & 24)
  • Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)(Baseline to weeks 24, 36 & 52)
  • Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)(Baseline to weeks 8 16, 20, & 24)
  • Change in IGA (Investigator Global Assessment) From Baseline (Part 2)(Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52)
  • Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)(Baseline to weeks 2, 8, 16, 20, & 24)
  • Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52)
  • Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)(Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52)
  • Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)(Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24)
  • Incidence Rate of Loss of EASI 75 (Part 2)(Week 24 to week 52)
  • Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)(Baseline through week 24)
  • Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)(Week 24 through week 68)
  • Percentage of Participants With Treatment-emergent ADA (Part 2)(Baseline through week 68)
  • Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)(Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52)
  • Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)(Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 & 24)
  • Incidence Rate of Loss of IGA 0/1 (Part 2)(Week 24 to week 68)
  • Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)(Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24)
  • Incidence Rate of Loss of EASI 50 (Part 2)(Week 24 to week 52)
  • Serum KY1005 Concentration Assessed Throughout the Study (Part 1)(Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24)
  • Serum KY1005 Concentration Assessed Throughout the Study (Part 2)(Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52)
  • Percentage of Participants With Treatment-emergent ADA (Part 1)(Baseline through week 24)

研究者

发起方
Kymab Limited
申办方类型
Industry
责任方
Sponsor

研究点 (101)

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