Clinical trial NCT06135415: A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Keratosis, Actinic
Keywords: Actinic Keratosis
Keratosis
Keratosis, Actinic
Precancerous condition
Neoplasms
Sun Damaged Skin
Actinic Keratoses
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 centimeter square (cm\^2) and up to 100 cm\^2 in adult participants with actinic keratosis (AK).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 113.
* 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.

Primary outcomes:
measure: Percent Change From Baseline in Lesion Count at Day 57
timeFrame: Baseline, Day 57
Secondary outcomes:
measure: Proportion of Participants With Partial Clearance (PC) at Day 57
timeFrame: At Day 57
measure: Proportion of Participants With Complete Clearance (CC) at Day 57
timeFrame: At Day 57
measure: Proportion of Participants With Partial Clearance (PC) by Day 113
timeFrame: Baseline up to Day 113
measure: Proportion of Participants With Complete Clearance (CC) by Day 113
timeFrame: Baseline up to Day 113
measure: Total Number of Lesions per Participant in the TF at Specific Timepoints
timeFrame: Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113
measure: Percent Change From Baseline in lesion count in the TF at Specific Timepoints
timeFrame: Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113
measure: Number of New Lesions per Participant in the TF at Specific Timepoints
timeFrame: At Day 8, 15, 29, 57, 64, 71, 85, and 113
measure: Number of Baseline Lesions per Participant Present in the TF at Specific Timepoints
timeFrame: Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113
measure: Change From Baseline in Skindex-16 Questionnaire Overall Score and Domain Scores (Symptoms, Emotions, and Functioning) at Day 57
timeFrame: Baseline, Day 57
measure: Change from Baseline in Skindex-16 Questionnaire Overall Score and Domain Scores (Symptoms, Emotions, and Functioning) at Day 113 in Participants who Receive 2 Treatment Courses
timeFrame: Baseline, Day 113
measure: Cosmetic Outcome as Assessed by the Participant at Day 57
timeFrame: At Day 57
measure: Cosmetic Outcome as Assessed by the Investigator at Day 57
timeFrame: At Day 57
measure: Cosmetic Outcome in Participants who Receive 2 Treatment Courses, as Assessed by Participants at Day 113
timeFrame: At Day 113
measure: Cosmetic Outcome in Participants who Receive 2 Treatment Courses, as Assessed by Investigator at Day 113
timeFrame: At Day 113
measure: Treatment Satisfaction Questionnaire for Medications (TSQM) Transformed Total Scores at Day 57
timeFrame: At Day 57
measure: TSQM Transformed Scores in Participants who Receive 2 Treatment Courses at Day 113
timeFrame: At Day 113
measure: Local Tolerability Score at Specific Timepoints for Each Individual Sign
timeFrame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
measure: Maximum Local Tolerability Score in Treatment Course for Each Individual Sign
timeFrame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
measure: Time to Maximum Local Tolerability Score Observed in Treatment Course for Each Individual Sign
timeFrame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
measure: Local Tolerability Signs Composite Score at Specific Timepoints
timeFrame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
measure: Maximum Local tolerability Signs Composite Score in Treatment Course
timeFrame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
measure: Time to Maximum Local Tolerability Signs Composite Score Observed in Treatment Course
timeFrame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
measure: Number of Participants Showing Changes in Pigmentation and Scarring in the TF at Specific Timepoints
timeFrame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
measure: Number of Participants With Adverse Event (AE), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
timeFrame: From Screening up to Day 113
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: From Screening up to Day 113
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: From Screening up to Day 113
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Site 17
city: Bad Bentheim
country: Germany
facility: Site 1
city: Bochum
country: Germany
facility: Site 3
city: Dresden
country: Germany
facility: Site 18
city: Hamburg
country: Germany
facility: Site 2
city: Hamburg
country: Germany
facility: Site 5
city: Mahlow
country: Germany
facility: Site 4
city: Wuppertal
country: Germany
facility: Site 6
city: Bari
country: Italy
facility: Site 24
city: Bologna
country: Italy
facility: Site 25
city: Brescia
country: Italy
facility: Site 19
city: Cagliari
country: Italy
facility: Site 26
city: Firenze
country: Italy
facility: Site 23
city: Pisa
country: Italy
facility: Site 22
city: Reggio Emilia
country: Italy
facility: Site 27
city: Roma
country: Italy
facility: Site 20
city: Roma
country: Italy
facility: Site 21
city: Roma
country: Italy
facility: Site 7
city: Heemstede
country: Netherlands
facility: Site 29
city: Maastricht
country: Netherlands
facility: Site 28
city: Kraków
country: Poland
facility: Site 31
city: Ossy
country: Poland
facility: Site 30
city: Warsaw
country: Poland
facility: Site 10
city: Warsaw
country: Poland
facility: Site 11
city: Warsaw
country: Poland
facility: Site 9
city: Wrocław
country: Poland
facility: Site 8
city: Barcelona
country: Spain
facility: Site 12
city: Barcelona
country: Spain
facility: Site 14
city: Barcelona
country: Spain
facility: Site 34
city: Granada
country: Spain
facility: Site 33
city: Madrid
country: Spain
facility: Site 13
city: Salamanca
country: Spain
facility: Site 32
city: Valencia
country: Spain
facility: Site 15
city: Valencia
country: Spain
facility: Site 35
city: Zaragoza
country: Spain
facility: Site 16
Study officials:
References: