Trial Title:
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis
NCT ID:
NCT06135415
Condition:
Keratosis, Actinic
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Tirbanibulin
Conditions: Keywords:
Actinic Keratosis
Keratosis
Keratosis, Actinic
Precancerous condition
Neoplasms
Sun Damaged Skin
Actinic Keratoses
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Tirbanibulin
Description:
Participants will apply tirbanibulin ointment topically on the face or balding scalp with
AK.
Arm group label:
Tirbanibulin 10 mg/g
Other name:
Klisyri®
Intervention type:
Other
Intervention name:
Vehicle ointment
Description:
Participants will apply vehicle ointment topically on the face or balding scalp with AK.
Arm group label:
Vehicle ointment
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Site 1
Address:
City:
Bad Bentheim
Country:
Germany
Status:
Recruiting
Facility:
Name:
Site 3
Address:
City:
Bochum
Country:
Germany
Status:
Recruiting
Facility:
Name:
Site
Address:
City:
Düsseldorf
Country:
Germany
Status:
Recruiting
Facility:
Name:
Site 2
Address:
City:
Hamburg
Country:
Germany
Status:
Recruiting
Facility:
Name:
Site 4
Address:
City:
Mahlow
Country:
Germany
Status:
Recruiting
Facility:
Name:
Site 6
Address:
City:
Wuppertal
Country:
Germany
Status:
Recruiting
Facility:
Name:
Site 7
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Facility:
Name:
Site 10
Address:
City:
Warsaw
Country:
Poland
Status:
Recruiting
Facility:
Name:
Site 11
Address:
City:
Warsaw
Country:
Poland
Status:
Recruiting
Facility:
Name:
Site 9
Address:
City:
Warsaw
Country:
Poland
Status:
Recruiting
Facility:
Name:
Site 8
Address:
City:
Wrocław
Country:
Poland
Status:
Recruiting
Facility:
Name:
Site 12
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Site 13
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Site 14
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Facility:
Name:
Site 15
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Facility:
Name:
Site 16
Address:
City:
Zaragoza
Country:
Spain
Status:
Recruiting
Start date:
December 21, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Almirall, S.A.
Agency class:
Industry
Source:
Almirall, S.A.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06135415
