NCT06319794已完成2 期
A Randomized Phase 2 Proof-of-Concept Study to Evaluate the Efficacy and Safety of Topical Bimiralisib Application in Participants Suffering From Actinic Keratosis on the Face and/or Scalp and/or Back of Hands Over a 2 and 4-week Treatment Period
TORQUR2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年4月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1
研究概览
简要总结
The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands
详细描述
This is a multi-center, randomized, open label, parallel group study. The study products will be applied to the target lesions for a duration of 2 or 4 weeks of treatment.
The study consists of the following periods:
- Screening (up to 30 days)
- Treatment (2 or 4 weeks)
- Follow-Up (4 weeks)
Participants will be randomized to one of two groups (1:1):
- Arm A: Topical bimiralisib gel treatment for 2 weeks
- Arm B: Topical bimiralisib gel treatment for 4 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be of at least 50 years of age, at the time of signing the informed consent.
- •Have a clinical diagnosis of stable, clinically typical actinic keratosis.
- •Have at least 3 actinic keratosis lesions contained within contiguous treatment regions of face and/or scalp and/or back of hands.
- •Must agree not to use any product on the treatment area during the entire course of study except for Investigator-approved cleanser, sunscreen, wash, and non-medicated makeup.
- •Must be willing to comply with sun avoidance measures for all exposed areas including use of Investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.
- •Must be in good general health (ECOG 0-1)
- •Participants of reproductive potential must agree to use double effective contraception from screening until 90 days after discontinuing study treatment.
- •Female participants who had a menstrual cycle within 2 years prior to screening must have a negative serum pregnancy test at screening and a negative urine pregnancy test on their first treatment day.
- •Must be capable of giving signed informed consent
排除标准
- •Known or suspected hypersensitivity to any of the excipients of bimiralisib gel.
- •Clinically atypical and/or rapidly changing actinic keratosis lesions in the treatment area.
- •Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
- •Participation in any clinical research study within 30 days of the Baseline Visit.
- •Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy, cryotherapy) within 4 weeks of the Baseline visit and within 2 cm of the selected treatment area.
- •Use of sun lamps, tanning beds, and tanning booths during the 4 weeks prior to the Baseline Visit or planned use during the study.
- •Use of any retinoids within 90 days of the Baseline Visit, or glucocorticosteroids, methotrexate or other anti-metabolites or nicotinamide within 28 days of the Baseline Visit.
- •Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit.
- •Any other malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not in the treatment area that were treated with curative intent and are without recurrence.
- •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
研究组 & 干预措施
Bimiralisib - 4 weeks treatment
Experimental
Topical bimiralisib for 4 weeks
干预措施: Bimiralisib (Drug)
Bimiralisib - 2 weeks treatment
Experimental
Topical bimiralisib for 2 weeks
干预措施: Bimiralisib (Drug)
结局指标
主要结局
Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1
时间窗: Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B)
Improvement from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale where 0 is complete clearance and 4 is no improvement)
次要结局
- Proportion of participants with partial or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arms)(Day 15 (Treatment Arm A), Day 29 (Treatment Arm B))
- Incidence of Treatment-Emergent Adverse Events(From first application of bimiralisib until 28 days after the last application)
- Incidence of local skin reactions(From first application of bimiralisib until 28 days after the last application)
研究者
研究点 (2)
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