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A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

Primary Purpose

Keratosis, Actinic

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tirbanibulin ointment 1%
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratosis, Actinic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that measures approximately 100 cm^2 (eg, mid face) and contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK) lesions within the TF
  • Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study
  • 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:

  • Presence in the TF of

    1. Clinically atypical and/or rapidly changing AK lesions in the TF
    2. Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn
    3. Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria)
    4. History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell carcinoma (BCC), or other malignant tumors in the TF
    5. Any other dermatological disease that causes difficulty with examination
  • Previous treatment with tirbanibulin ointment 1%.
  • Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 57
  • Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening visit
  • Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit

Sites / Locations

  • Almirall Investigation Site 7
  • Almirall Investigation Site 6
  • Almirall Investigation Site 3
  • Almirall Investigation Site 5
  • Almirall Investigation Site 4
  • Almirall Investigational Site 1
  • Almirall Investigation Site 2

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tirbanibulin (Klisyri®)

Arm Description

Participants will apply tirbanibulin ointment 1% once daily for 5 days beginning Day 1. Participants will be evaluated for safety, tolerability, and the presence of AK lesions in the treatment field (TF) until completion of the response assessment period at Day 57

Outcomes

Primary Outcome Measures

Local Tolerability Score for Signs Including Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration
Local tolerability score is evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication is applied. These symptoms are assessed by using a 4 - point scale of 0 - 3, where 0 = none and 3 = severe. The higher score indicates severe symptoms.
Change from Baseline in Maximum Local Tolerability Score
Change from baseline in maximum local tolerability score will be assessed for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. Local tolerability score for each signs are assessed by using a 4 - point scale of 0 - 3, where 0 = none and 3 = severe.
Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration
Time to maximum local tolerability score for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration will be assessed. The higher score indicates severe symptoms.
Local Tolerability Signs Composite Score
Local tolerability signs composite score (0-18) by visit, defined as the sum of the scores graded from 0 to 3 on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration.
Change From Baseline in Maximum Local Tolerability Signs Composite Score
Change from baseline in maximum local tolerability signs composite score will be assessed for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration.
Time to Maximum Local Tolerability Composite Score
Time to maximum local tolerability composite score for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration will be assessed.
Number of Participants with change from baseline in hypopigmentation in treatment field
Number of participants with change from baseline in hypopigmentation in the treatment area will be assessed.
Number of Participants with change from baseline in hyperpigmentation in treatment field
Number of participants with change from baseline in hyperpigmentation in the treatment area will be assessed.
Number of Participants with change from baseline in Scarring in treatment field
Number of participants with change from baseline in scarring in the treatment area will be assessed.
Number of Participants With Any Treatment-emergent Adverse Events
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered an Investigational Product. An AE did not necessarily have a causal relationship with the medicinal product. Treatment-emergent Adverse Events (TEAEs) were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.
Number of Participants With Any Treatment-emergent Serious Adverse Events
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant laboratory parameters (included hematology, blood chemistry and urinalysis) will be assessed.
Number of Participants With Vital Signs Abnormalities
Number of participants with vital signs (included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature) will be reported
Number of Participants With Physical Examination Abnormalities
Number of participants with physical examination abnormalities (weight and height) measurements will be reported.
Number of Participants With Electrocardiograms (ECGs) Abnormalities
Number of participants with ECG (heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals) abnormalities will be reported.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2022
Last Updated
February 14, 2023
Sponsor
Almirall, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05279131
Brief Title
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
Official Title
A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm^2 on the face or balding scalp.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis, Actinic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tirbanibulin (Klisyri®)
Arm Type
Experimental
Arm Description
Participants will apply tirbanibulin ointment 1% once daily for 5 days beginning Day 1. Participants will be evaluated for safety, tolerability, and the presence of AK lesions in the treatment field (TF) until completion of the response assessment period at Day 57
Intervention Type
Drug
Intervention Name(s)
Tirbanibulin ointment 1%
Intervention Description
Participants will apply Tirbanibulin ointment 1% topically for 5 days over a field of approximately 100 cm^2 on the face or balding scalp with Actinic Keratosis (AK).
Primary Outcome Measure Information:
Title
Local Tolerability Score for Signs Including Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration
Description
Local tolerability score is evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication is applied. These symptoms are assessed by using a 4 - point scale of 0 - 3, where 0 = none and 3 = severe. The higher score indicates severe symptoms.
Time Frame
Up to Day 57
Title
Change from Baseline in Maximum Local Tolerability Score
Description
Change from baseline in maximum local tolerability score will be assessed for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. Local tolerability score for each signs are assessed by using a 4 - point scale of 0 - 3, where 0 = none and 3 = severe.
Time Frame
Baseline to up to Day 57
Title
Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration
Description
Time to maximum local tolerability score for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration will be assessed. The higher score indicates severe symptoms.
Time Frame
Baseline up to Day 57
Title
Local Tolerability Signs Composite Score
Description
Local tolerability signs composite score (0-18) by visit, defined as the sum of the scores graded from 0 to 3 on all six individual tolerability sign categories - erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration.
Time Frame
Baseline up to Day 57
Title
Change From Baseline in Maximum Local Tolerability Signs Composite Score
Description
Change from baseline in maximum local tolerability signs composite score will be assessed for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration.
Time Frame
Baseline up to Day 57
Title
Time to Maximum Local Tolerability Composite Score
Description
Time to maximum local tolerability composite score for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration will be assessed.
Time Frame
Baseline up to Day 57
Title
Number of Participants with change from baseline in hypopigmentation in treatment field
Description
Number of participants with change from baseline in hypopigmentation in the treatment area will be assessed.
Time Frame
Baseline up to Day 57
Title
Number of Participants with change from baseline in hyperpigmentation in treatment field
Description
Number of participants with change from baseline in hyperpigmentation in the treatment area will be assessed.
Time Frame
Baseline up to Day 57
Title
Number of Participants with change from baseline in Scarring in treatment field
Description
Number of participants with change from baseline in scarring in the treatment area will be assessed.
Time Frame
Baseline up to Day 57
Title
Number of Participants With Any Treatment-emergent Adverse Events
Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered an Investigational Product. An AE did not necessarily have a causal relationship with the medicinal product. Treatment-emergent Adverse Events (TEAEs) were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.
Time Frame
Baseline up to Day 57
Title
Number of Participants With Any Treatment-emergent Serious Adverse Events
Description
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Time Frame
Baseline to up to Day 57
Title
Number of Participants With Clinically Significant Laboratory Abnormalities
Description
Number of participants with clinically significant laboratory parameters (included hematology, blood chemistry and urinalysis) will be assessed.
Time Frame
Up to Day 57
Title
Number of Participants With Vital Signs Abnormalities
Description
Number of participants with vital signs (included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature) will be reported
Time Frame
Up to Day 57
Title
Number of Participants With Physical Examination Abnormalities
Description
Number of participants with physical examination abnormalities (weight and height) measurements will be reported.
Time Frame
Up to Day 57
Title
Number of Participants With Electrocardiograms (ECGs) Abnormalities
Description
Number of participants with ECG (heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals) abnormalities will be reported.
Time Frame
Up to Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that measures approximately 100 cm^2 (eg, mid face) and contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK) lesions within the TF Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study 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: Presence in the TF of Clinically atypical and/or rapidly changing AK lesions in the TF Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria) History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell carcinoma (BCC), or other malignant tumors in the TF Any other dermatological disease that causes difficulty with examination Previous treatment with tirbanibulin ointment 1%. Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 57 Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening visit Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit
Facility Information:
Facility Name
Almirall Investigation Site 7
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Almirall Investigation Site 6
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Almirall Investigation Site 3
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Almirall Investigation Site 5
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Almirall Investigation Site 4
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Almirall Investigational Site 1
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Almirall Investigation Site 2
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

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