A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp

NCT03285477 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: KX01-AK-003U1111-1191-8233
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 30

Brief Summary

This Phase III study is designed to evaluate the efficacy and safety of KX2-391 Ointment in adult participants when applied to an area of skin containing 4-8 stable, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.

Conditions

Actinic Keratoses

Keywords

Actinic Keratosis; Keratosis; Keratosis, Actinic; Skin Diseases; Actinic Keratoses; Precancerous Conditions; Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions

  Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.

  Day 57

Secondary Outcomes (11)

• Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57

  Day 57

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

  Days 8, 15, 29 and 57

• Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57

  3, 6, 9 and 12 months post-Day 57

• Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)

  Day 57

• Number of Participants With Pigmentation and Scarring in the Treatment Area

  Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp

Drug: Placebo

KX2-391 Ointment 1%

EXPERIMENTAL

KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp

Drug: KX2-391 Ointment 1%

Interventions

Placebo DRUG

Vehicle Ointment was used in participants with Clinically typical AK on the face or scalp.

Placebo

KX2-391 Ointment 1% DRUG

The experimental drug, KX2-391 Ointment 1% was used in participants with Clinically typical AK on the face or scalp.

KX2-391 Ointment 1%

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 greater than or equal to (≥) 18 years old
• A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions
• Participants who in the judgment of the Investigator, are in good general health
• Females must be postmenopausal \[greater than (\>) 45 years of age with at least 12 months of amenorrhea\], surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of childbearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device or complete abstinence from sexual intercourse.
• Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment.
• All participants must agree not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment
• Willing to avoid excessive sun or UV exposure
• Able to comprehend and are willing to sign the informed consent form (ICF).

You may not qualify if:

• Clinically atypical and/or rapidly changing AK lesions on the treatment area
• Location of the selected area is:
• On any location other than the face or scalp
• Within 5 cm of an incompletely healed wound
• Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
• Been previously treated with KX2-391 Ointment
• Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
• Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit
• Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:
• Cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area
• Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area
• Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area
• Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:
• Treatment with immunomodulators (eg, azathioprine), cytotoxic drugs (eg, cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers
• Treatment with systemic medications that suppress the immune system (eg, cyclosporine, prednisone, methotrexate, alefacept, infliximab)

Sponsors & Collaborators

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

Study Sites (30)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Advanced Research Associates

Glendale, Arizona, 85308, United States

Location

Center For Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Contour Dermatology

Rancho Mirage, California, 92270, United States

Location

Western States Clincial Research, Inc.

Wheat Ridge, Colorado, 80033, United States

Location

Skin care Research, Inc

Boca Raton, Florida, 33486, United States

Location

Olympian Clinical Research

Clearwater, Florida, 33756, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Arlington Dermatology

Arlington Heights, Illinois, 60005, United States

Location

Deaconess Clinic Downtown

Evansville, Indiana, 47713, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

ActivMed Practices & Research, Inc.

Beverly, Massachusetts, 01915, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Skin Specialists PC

Omaha, Nebraska, 68144, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Mount Sinai Beth Israel

New York, New York, 10013, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

PMG Research of Cary

Cary, North Carolina, 27511, United States

Location

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, 28277, United States

Location

PMG Research of Winston-Salem,LLC

Winston-Salem, North Carolina, 27103, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Synexus US

Greer, South Carolina, 29650, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84117, United States

Location

Related Publications (1)

• Blauvelt A, Kempers S, Lain E, Schlesinger T, Tyring S, Forman S, Ablon G, Martin G, Wang H, Cutler DL, Fang J, Kwan MR; Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512-520. doi: 10.1056/NEJMoa2024040.

  PMID: 33567191 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic; Keratosis; Skin Diseases; Precancerous Conditions; Neoplasms

Condition Hierarchy (Ancestors)

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

  Athenex, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All Central Vendors and the sponsor were masked. The sponsor was unblind at the end of Day 57.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study tested KX2-391 Ointment 1% against a placebo.

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 18, 2017
• Study Start: September 18, 2017
• Primary Completion: May 3, 2018
• Study Completion: April 24, 2019
• Last Updated: April 13, 2021
• Results First Posted: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)