Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

NCT02838628 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: KX01-AK-002U1111-1173-5677
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 16

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response of Actinic Keratosis

  Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57.

  Day 57

Secondary Outcomes (13)

• Percentage of Participants With Partial Response of Actinic Keratosis

  Day 57

• Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57

  Baseline, Days 8, 15, 29 and 57

• Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)

  Baseline up to Day 57 (Treatment and follow-up period)

• Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period

  From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period)

• Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)

  Day 57

Study Arms (2)

KX2-391 50 mg (Days 1 to 5)

EXPERIMENTAL

Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm\^2) treatment area, once daily for 5 consecutive days.

Drug: 50 mg of KX2-391 Ointment 1%

KX2-391 50 mg (Days 1 to 3)

EXPERIMENTAL

Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm\^2 treatment area, once daily for 3 consecutive days.

Drug: 50 mg of KX2-391 Ointment 1%

Interventions

50 mg of KX2-391 Ointment 1% DRUG

Dose: 50 mg; Route of administration: Topical

KX2-391 50 mg (Days 1 to 5)

Eligibility Criteria

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

You may qualify if:

• Males and females ≥18 years old
• Clinical diagnosis of stable, clinically typical actinic keratosis
• A define treatment area on the face or scalp
• 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
• Males who have not had a vasectomy must agree to use barrier contraception
• Participants who in the judgment of the Investigator, are in good general health
• Willing to avoid excessive sun exposure
• Able to comprehend and are willing to sign an informed consent form (ICF)

You may not qualify if:

• Clinically atypical and/or rapidly changing AK lesions on the treatment area
• 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
• 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
• Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
• Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
• A history of sensitivity and/or allergy to any of the ingredients in the study medication
• 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
• 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
• Females who are pregnant or nursing
• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead
• Athenex, Inc.: collaborator

Study Sites (16)

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

eStudy Site

La Mesa, California, 91942, United States

Location

Palmtree Clinical Research, Inc.

Palm Springs, California, 92262, United States

Location

Horizons Clinical Research Center

Denver, Colorado, 80220, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

International Dermatology Research

Miami, Florida, 33144, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Forward Clinical Trials, Inc.

Tampa, Florida, 33624, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Dermatology and Laser Center of Charleston

Charleston, South Carolina, 29414, United States

Location

Institute of Clinical Research - Tennessee, LLC

Murfreesboro, Tennessee, 37130, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Dermatology Clinical Research Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 33196758 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Head of Global Clinical Development
• Organization: Almirall S.A.

rd@almirall.com

+34932913000

Study Officials

• Jane Fang, MD

  Kinex Pharmaceuticals Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: April 11, 2016
• Primary Completion: January 11, 2017
• Study Completion: December 22, 2017
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)