A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis

NCT06135415 | Completed Phase 3 FDA Drug

• 2 other identifiers: M-14867-332023-505487-11-00
• Study Type: interventional
• Target: 280
• Locations: 5 countries
• Sites: 35

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).

Conditions

Keratosis, Actinic

Keywords

Actinic Keratosis; Keratosis; Keratosis, Actinic; Precancerous condition; Neoplasms; Sun Damaged Skin; Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Lesion Count at Day 57

  Percentage change from baseline in the AK lesion count will be assessed.

  Baseline, Day 57

Secondary Outcomes (7)

• 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

• Local Tolerability Signs Composite Score at Specific Timepoints

  At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113

Study Arms (2)

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.

Drug: Tirbanibulin

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.

Other: Vehicle ointment

Interventions

Tirbanibulin DRUG

Participants will apply tirbanibulin ointment topically on the face or balding scalp with AK.

Also known as: Klisyri®

Tirbanibulin 10 mg/g

Vehicle ointment OTHER

Participants will apply vehicle ointment topically on the face or balding scalp with AK.

Vehicle ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (35)

Site 17

Augsburg, Germany

Location

Site 1

Bad Bentheim, Germany

Location

Site 3

Bochum, Germany

Location

Site 18

Dresden, Germany

Location

Site 2

Hamburg, Germany

Location

Site 5

Hamburg, Germany

Location

Site 4

Mahlow, Germany

Location

Site 6

Wuppertal, Germany

Location

Site 24

Bari, Italy

Location

Site 25

Bologna, Italy

Location

Site 19

Brescia, Italy

Location

Site 26

Cagliari, Italy

Location

Site 23

Florence, Italy

Location

Site 22

Pisa, Italy

Location

Site 27

Reggio Emilia, Italy

Location

Site 20

Roma, Italy

Location

Site 21

Roma, Italy

Location

Site 7

Roma, Italy

Location

Site 29

Heemstede, Netherlands

Location

Site 28

Maastricht, Netherlands

Location

Site 31

Krakow, Poland

Location

Site 30

Ossy, Poland

Location

Site 10

Warsaw, Poland

Location

Site 11

Warsaw, Poland

Location

Site 9

Warsaw, Poland

Location

Site 8

Wroclaw, Poland

Location

Site 12

Barcelona, Spain

Location

Site 14

Barcelona, Spain

Location

Site 34

Barcelona, Spain

Location

Site 33

Granada, Spain

Location

Site 13

Madrid, Spain

Location

Site 32

Salamanca, Spain

Location

Site 15

Valencia, Spain

Location

Site 35

Valencia, Spain

Location

Site 16

Zaragoza, Spain

Location

MeSH Terms

Conditions

Keratosis, Actinic; Keratosis; Precancerous Conditions; Neoplasms

Interventions

tirbanibulin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 21, 2023
• Primary Completion: April 30, 2025
• Study Completion: November 25, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10); DE (8); PL (6); ES (9); NL (2)