A Phase 2a, Open-Label, Multicenter, Activity and Safety Study of KX2-391 Ointment 1% in Subjects With Actinic Keratosis on the Face or Scalp
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 16
- 主要终点
- Percentage of Participants With Complete Response of Actinic Keratosis
研究概览
简要总结
In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.
详细描述
This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK.
The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥18 years old
- •Clinical diagnosis of stable, clinically typical actinic keratosis
- •A define treatment area on the face or scalp
- •Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment
- •Males who have not had a vasectomy must agree to use barrier contraception
- •Participants who in the judgment of the Investigator, are in good general health
- •Willing to avoid excessive sun exposure
- •Able to comprehend and are willing to sign an informed consent form (ICF)
排除标准
- •Clinically atypical and/or rapidly changing AK lesions on the treatment area
- •Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence
- •Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1
- •Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
- •Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
- •A history of sensitivity and/or allergy to any of the ingredients in the study medication
- •A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation
- •Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation
- •Females who are pregnant or nursing
- •Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
研究组 & 干预措施
KX2-391 50 mg (Days 1 to 5)
Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm^2) treatment area, once daily for 5 consecutive days.
干预措施: 50 mg of KX2-391 Ointment 1% (Drug)
KX2-391 50 mg (Days 1 to 3)
Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.
干预措施: 50 mg of KX2-391 Ointment 1% (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response of Actinic Keratosis
时间窗: Day 57
Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57.
次要结局
- Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)(Baseline up to Day 57 (Treatment and follow-up period))
- Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period(From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period))
- Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)(Day 57)
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(Baseline up to Day 57)
- Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE)(Baseline up to Day 57)
- Accumulation Ratio (R)(Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1))
- Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57(Baseline, Days 8, 15, 29 and 57)
- Number of Participants With Clinically Significant Abnormalities in Laboratory(Baseline to Day 57)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)(Baseline up to Day 57)
- Percentage of Participants With Partial Response of Actinic Keratosis(Day 57)
- Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391(Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1))
- Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391(Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1))
- Minimum Observed Plasma Concentration (Cmin) of KX2-391(Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1))