NCT05999799终止2 期
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC Injection in Adult Participants With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 161
- 试验地点
- 90
- 主要终点
- Percent Change from Baseline (PCFB) in the Eczema Area and Severity Index (EASI) at Week 16
研究概览
简要总结
This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.
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
- Double (Participant, Investigator)
盲法说明
Participants and investigator are blinded to study intervention.
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
- •Adult participants 18 years to 75 years of age
- •Participants with:
- •AtD defined by the AAD Consensus Criteria.
- •Diagnosis of AtD ≥1 year.
- •An IGA score ≥
- •AtD involvement of ≥10% body surface area (BSA).
- •EASI score ≥16
- •Baseline pruritus numerical rating scale average score for maximum intensity of at least
- •Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions:
- •Participants who stopped treatment due to non-response, partial response, loss of efficacy.
- •Participants who stopped treatment due to intolerance or AEs.
- •Participant with a recent history less than or equal to (≤6) months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication.
- •Participants for whom prescription topical medications are not tolerated.
- •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical study
排除标准
- •Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits.
- •Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed)
- •Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit.
- •Symptomatic herpes zoster within 3 months prior to screening
- •Uncontrolled hypertension.
- •Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- •Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment.
- •Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Breast cancer within the past 10 years.
- •History or presence of significant medical illness including but not limited to cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological, or psychiatric disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
- •Previously treated with any oral Janus Kinase inhibitor (JAKi) or other kinase inhibitors, experimental or approved.
- •Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma.
- •Presence of Hepatitis B surface antibody (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
- •Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
- •Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
- •Positive HIV antibody test.
- •Evidence of active or latent TB as documented by medical history, examination, and TB testing with a positive QuantiFERON test at initial Screening visit.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received placebo subcutaneous (SC) injections for 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline (PCFB) in the Eczema Area and Severity Index (EASI) at Week 16
时间窗: Baseline and Week 16
EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
次要结局
- Percent Change from Baseline (PCFB) EASI Score for GSK1070806 at Each Time Point(Baseline and up to Week 16)
- Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 16(Baseline and Week 16)
- Number of Participants Achieving Investigator's Global Assessment (IGA) score of 0 or 1 and a Reduction from Baseline ≥ 2 Points at Week 16(Baseline and up to Week 16)
- Number of Participants Achieving PP-NRS Reduction of ≥4 points from Baseline at Week. 16(Baseline and Week 16)
- Number of Participants Achieving EASI Reduction of Greater than or Equal to (≥) 75 Percent (%) from Baseline at Week 16(Baseline and Week 16)
- Number of Participants Achieving EASI Reduction of ≥50%, 90% or 100% from Baseline at Week 16(Baseline and Week 16)
- Change from Baseline in the Body surface area (BSA) of GSK1070806 at Week 16(Baseline and Week 16)
- Change from Baseline in PRO Measure of Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance 8b at Week 16(Baseline and Week 16)
- Occurrences of Adverse Events (AEs), Serious AE (SAEs), and AEs of Special Interest (AESI)(Up to Week 28)
- Change from Baseline in Haematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, White Blood Cell (WBC), and Platelet Count (Giga Cells per Litre)(Baseline and Up to Week 28)
- Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) (International Units per Litre)(Baseline and Up to Week 28)
- Change from Baseline in PRO Measure of Dermatology Life Quality Index (DLQI) at Week 16(Baseline and Week 16)
- Change from Baseline in PRO Measure of Hospital Anxiety and Depression Scale (HADS) at Week 16(Baseline and Week 16)
- Number of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Reduction of ≥ 50% or ≥75% from Baseline at Week 16(Baseline and Week 16)
- Change from Baseline in the SCORAD of GSK1070806 at Week 16(Baseline and Week 16)
- Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT), and Alkaline Phosphatase (AP) (Units per Litre)(Baseline and Up to Week 28)
- Number of Participants with Greater than or Equal to (≥) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE)(Up to Week 28)
- Change from Baseline in Patient Reported Outcomes (PRO) Measure of Skin Pain Numerical Rating Scale (SP-NRS) at Week 16(Baseline and Week 16)
- Change from Baseline in PRO Measure of Patient Oriented Eczema Measure (POEM) at Week 16(Baseline and Week 16)
- Change from Baseline in Clinical Chemistry Parameter: Total Bilirubin (Micromoles per Litre)(Baseline and Up to Week 28)
- Change from Baseline in PRO Measure of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue at Week 16(Baseline and Week 16)
- Change from Baseline in PRO Measure of Brief Fatigue Inventory (BFI) - Item 3 at Week 16(Baseline and Week 16)
- Change from Baseline in PRO Measure of Work Productivity and Activity Impairment Questionnaire-Atopic Dermatitis (WPAI- AD) at Week 16(Baseline and Week 16)
- Change from Baseline in Haematology Parameter: Haemoglobin (Hb) (Grams per Litre)(Baseline and Up to Week 28)
研究者
研究点 (90)
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