A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)

NCT ID: NCT03285490

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-04-24

Brief Summary

This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% 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.

Detailed Description

This study was a double-blinded, multicenter, efficacy, and safety study of KX2-391 ointment administered topically to the face or scalp of participants with AK.

The study consisted of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received up to 5 consecutive days of topical treatment. Efficacy (lesion counts) and safety evaluations were performed.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KX2-391 Ointment 1%

KX2-391 Ointment was applied once daily for 5 consecutive days on the face or scalp.

Group Type: EXPERIMENTAL

KX2-391 Ointment 1%

Intervention Type: DRUG

Dose: 1% (250 mg single-use packets); Dosage form: Ointment; Route of administration: Topical

Placebo

The Vehicle Ointment was applied once daily for 5 consecutive days on the face or scalp.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dosage form: Ointment; Route of administration: Topical

Interventions

KX2-391 Ointment 1%

Dose: 1% (250 mg single-use packets); Dosage form: Ointment; Route of administration: Topical

Intervention Type: DRUG

Placebo

Dosage form: Ointment; Route of administration: Topical

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males and females greater than or equal to (>=) 18 years old.

2. A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions.

3. Participants who in the judgment of the Investigator, were in good general health.

4. Females were 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, were using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever was longer, prior to study treatment and agreed 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.

5. Sexually active males who had not had a vasectomy, and whose partner was reproductively capable, must had agreed to use barrier contraception from Screening through 90 days after their last dose of study treatment.

6. All participants must had agreed not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment.

7. Willing to avoid excessive sun or ultraviolet exposure.

8. Able to comprehend and were willing to sign the informed consent form (ICF).

Exclusion Criteria

1. Clinically atypical and/or rapidly changing AK lesions on the treatment area.

2. Location of the selected area is:

• On any location other than the face or scalp.
• Within 5 centimeters (cm) of an incompletely healed wound.
• Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).

3. Been previously treated with KX2-391 Ointment.

4. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57.

5. 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.

6. Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:

• Cosmetic or therapeutic procedures (e.g., 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 were 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.

7. 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).

8. Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.

9. A history of sensitivity and/or allergy to any of the ingredients in the study medication.

10. A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., 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.

11. 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.

12. Females who were pregnant or nursing.

13. 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 was longer, before dosing.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Athenex, Inc.

INDUSTRY

Sponsor Role: collaborator

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jane Fang, MD

Role: STUDY_CHAIR

Athenex, Inc.

Locations

Alliance Dermatology

Phoenix, Arizona, United States

Synexus US

Tucson, Arizona, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Dermatology Specialists, Inc.

Murrieta, California, United States

Dermatology Specialists, Inc.

Oceanside, California, United States

Skin Surgery Medical Group, Inc.

San Diego, California, United States

Synexus

Santa Rosa, California, United States

AboutSkin Dermatology

Greenwood Village, Colorado, United States

Study Protocol, Inc

Boynton Beach, Florida, United States

Sweet Hope Research Specialty, Inc.

Miami Lakes, Florida, United States

Forward Clinical Trials, Inc.

Tampa, Florida, United States

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

DS Research

Louisville, Kentucky, United States

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Medisearch Clinical Trials

Saint Joseph, Missouri, United States

Henderson Dermatology Research

Henderson, Nevada, United States

Activmed Practices & Research, Inc

Portsmouth, New Hampshire, United States

Union Square Laser Dermatology

New York, New York, United States

Aventiv Research Inc.

Dublin, Ohio, United States

Oregon Medical Research Center

Portland, Oregon, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

Dermatology Associates Of Knoxville, PC

Knoxville, Tennessee, United States

Rivergate Dermatology Clinical Research

Springfield, Tennessee, United States

DermResearch

Austin, Texas, United States

Suzanne Bruce and Associates, P.A., The Center for Skin Research

Houston, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

The Education & Research Foundation, Inc.

Lynchburg, Virginia, United States

Dermatology Associates of Seattle

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33567191 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1191-8287

Identifier Type: OTHER

Identifier Source: secondary_id

KX01-AK-004

Identifier Type: -

Identifier Source: org_study_id