Clinical trial NCT02838628: Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
Official title: A Phase 2a, Open-Label, Multicenter, Activity and Safety Study of KX2-391 Ointment 1% in Subjects With Actinic Keratosis on the Face or Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Athenex, Inc.
First posted: 2016-07-20
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.

Detailed description: This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK.

The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were performed.

Eligibility criteria: Inclusion Criteria:

1. Males and females ≥18 years old
2. Clinical diagnosis of stable, clinically typical actinic keratosis
3. A define treatment area on the face or scalp
4. Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment
5. Males who have not had a vasectomy must agree to use barrier contraception
6. Participants who in the judgment of the Investigator, are in good general health
7. Willing to avoid excessive sun exposure
8. Able to comprehend and are willing to sign an informed consent form (ICF)

Exclusion Criteria:

1. Clinically atypical and/or rapidly changing AK lesions on the treatment area
2. Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence
3. Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1
4. Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
5. Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
6. A history of sensitivity and/or allergy to any of the ingredients in the study medication
7. A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation
8. Other 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
9. Females who are pregnant or nursing
10. Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.

Primary outcomes:
measure: Percentage of Participants With Complete Response of Actinic Keratosis
timeFrame: Day 57
Secondary outcomes:
measure: Percentage of Participants With Partial Response of Actinic Keratosis
timeFrame: Day 57
measure: Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57
timeFrame: Baseline, Days 8, 15, 29 and 57
measure: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 57 (Treatment and follow-up period)
measure: Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period
timeFrame: From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period)
measure: Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)
timeFrame: Day 57
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory
timeFrame: Baseline to Day 57
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Baseline up to Day 57
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
timeFrame: Baseline up to Day 57
measure: Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE)
timeFrame: Baseline up to Day 57
measure: Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391
timeFrame: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
measure: Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391
timeFrame: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
measure: Minimum Observed Plasma Concentration (Cmin) of KX2-391
timeFrame: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
measure: Accumulation Ratio (R)
timeFrame: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: La Mesa
country: United States
facility: eStudy Site
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston
state: South Carolina
city: Murfreesboro
country: United States
facility: Institute of Clinical Research - Tennessee, LLC
state: Tennessee
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center
state: Texas
Study officials:
affiliation: Kinex Pharmaceuticals Inc.
name: Jane Fang, MD
role: STUDY_CHAIR
References:
citation: Kempers S, DuBois J, Forman S, Poon A, Cutler E, Wang H, Cutler D, Fang J, Kwan R. Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results. J Drugs Dermatol. 2020 Nov 1;19(11):1093-1100. doi: 10.36849/JDD.2020.5576.