NCT06135415已完成3 期
A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 35
- 主要终点
- Percent Change From Baseline in Lesion Count at Day 57
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 square centimeters (cm^2) and up to 100 cm^2 in adult participants with actinic keratosis (AK).
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)
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
- •Participants having a TF on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that contains >= 4 to less than or equal to (<=) 12 clinically typical, visible, and discrete (non-confluent) AK lesions and measures more than 25 cm2 (example, one cheek) and up to approximately 100 cm2 (example, mid face).
- •Participants willing to avoid excessive sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study.
- •Women of childbearing potential (WOCBP), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months prior to screening) must have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration, be using highly effective methods of birth control for at least 30 days or 1 menstrual cycle, whichever is longer, and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product, agree to have pregnancy tests while in the study and at the end of the study, and agree not to be egg (oocyte) donors while on study and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product.
- •Sexually active males with female partners who are WOCBP must agree to use two forms of contraception, one of which must be barrier contraception, from screening through 90 days after their last dose of study treatment. All non-sterile male participants must agree not to donate sperm or attempt conception from screening through 90 days following their last dose of study treatment.
- •Participants should have ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines.
排除标准
- •Participants with clinically atypical and/or rapidly changing AK lesions in the TF; hyperkeratotic or hypertrophic lesions, recalcitrant disease (defined as failure to respond to cryosurgery on 2 previous occasions) and/or cutaneous horn; history of invasive SCC, Bowen's disease, BCC, or other malignant tumors in the TF; any other dermatological disease that causes difficulty with examination.
- •Location of the TF is on any location other than the face or balding scalp, within 5 centimeter (cm) of an incompletely healed wound, within 5 cm of a suspected BCC or other neoplasms, periorbital, lips, or nostrils.
- •Participants having a previous treatment with tirbanibulin 10 mg/g ointment.
- •Females who are pregnant or nursing or seeking to become pregnant.
- •Participants having intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication or therapy.
- •Participants with anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day
- •Participants with history of sensitivity and/or allergy to any of the ingredients in the study medication.
- •Participants with significant abnormalities on the medical history, physical examination (PE) findings, vital signs, clinical chemistry, or hematology results that in the judgment of the investigator may interfere with the interpretation of the results.
- •Participants with skin disease (example; atopic dermatitis, psoriasis, eczema) or condition (example; scarring, open wounds) that, in the opinion of the investigator, might interfere with the study conduct or evaluations, or which exposes the participant to unacceptable risk by study participation.
- •Participants with 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.
- •Participants who have participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing in the current study.
- •Participant who is employee or a relative to an employee at the research site or the Sponsor.
研究组 & 干预措施
Vehicle ointment
Placebo Comparator
Participants will apply vehicle ointment once daily for 5 consecutive days beginning on Day 1. All participants will be evaluated for efficacy, safety, and tolerability at Day 8, 15, 29, and 57. Participants who do not achieve CC at Day 57 will receive a second 5-day course of the treatment. Participants receiving a second treatment course will also be evaluated for efficacy, safety, and tolerability at Day 64, 71, and 85.
干预措施: Vehicle ointment (Other)
Tirbanibulin 10 mg/g
Experimental
Participants will apply tirbanibulin 10 mg/g ointment once daily for 5 consecutive days beginning on Day 1. All participants will be evaluated for efficacy, safety, and tolerability at Day 8, 15, 29, and 57. Participants who do not achieve complete clearance (CC) at Day 57 will receive a second 5-day course of the treatment. Participants receiving a second treatment course will also be evaluated for efficacy, safety, and tolerability at Day 64, 71, and 85.
干预措施: Tirbanibulin (Drug)
结局指标
主要结局
Percent Change From Baseline in Lesion Count at Day 57
时间窗: Baseline, Day 57
Percent change from baseline in the AK lesion count at Day 57 was reported.
次要结局
- Proportion of Participants With Partial Clearance (PC) at Day 57(At Day 57)
- Proportion of Participants With Complete Clearance (CC) at Day 57(At Day 57)
- Proportion of Participants With Partial Clearance (PC) by Day 113(Baseline up to Day 113)
- Proportion of Participants With Complete Clearance (CC) by Day 113(Baseline up to Day 113)
- Percentage of Participants With Partial Clearance at Day 57(At Day 57)
- Percentage of Participants With Complete Clearance at Day 57(At Day 57)
- Percentage of Participants With Partial Clearance at Day 113(At Day 113)
- Percentage of Participants With Complete Clearance at Day 113(At Day 113)
- Maximum Local Tolerability Signs Composite Score in Treatment Course(At Week 1 to 8 (Day 57) and Week 8 to 16 (Day 113))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAE of Special Interest(From Baseline up to Day 113)
- Local Tolerability Signs Composite Score at Specific Timepoints(At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113)
- Number of Participants With Adverse Event (AE), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)(From Screening up to Day 113)
- Maximum Local Tolerability Signs Composite Score in Treatment Course(At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113)
研究者
研究点 (35)
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