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

NCT03285490 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: KX01-AK-004U1111-1191-8287
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 30

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.

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; Keratosis; Keratosis, Actinic; Precancerous Conditions; Neoplasms; Sun Damaged Skin; Actinic Keratoses

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)

KX2-391 Ointment 1%

EXPERIMENTAL

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

Drug: KX2-391 Ointment 1%

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KX2-391 Ointment 1% DRUG

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

KX2-391 Ointment 1%

Placebo DRUG

Dosage form: Ointment; Route of administration: Topical

Placebo

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, were in good general health.
• 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.
• 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.
• 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.
• Willing to avoid excessive sun or ultraviolet exposure.
• Able to comprehend and were 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 centimeters (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 (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.
• 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)

Alliance Dermatology

Phoenix, Arizona, 85032, United States

Location

Synexus US

Tucson, Arizona, 85712, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Dermatology Specialists, Inc.

Murrieta, California, 92562, United States

Location

Dermatology Specialists, Inc.

Oceanside, California, 92056, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Synexus

Santa Rosa, California, 95405, United States

Location

AboutSkin Dermatology

Greenwood Village, Colorado, 80111, United States

Location

Study Protocol, Inc

Boynton Beach, Florida, 33437, United States

Location

Sweet Hope Research Specialty, Inc.

Miami Lakes, Florida, 33016, United States

Location

Forward Clinical Trials, Inc.

Tampa, Florida, 33624, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, 70601, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Henderson Dermatology Research

Henderson, Nevada, 89052, United States

Location

Activmed Practices & Research, Inc

Portsmouth, New Hampshire, 03801, United States

Location

Union Square Laser Dermatology

New York, New York, 10003, United States

Location

Aventiv Research Inc.

Dublin, Ohio, 43016, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Dermatology Associates Of Knoxville, PC

Knoxville, Tennessee, 37917, United States

Location

Rivergate Dermatology Clinical Research

Springfield, Tennessee, 37072, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

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

Houston, Texas, 77056, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

Dermatology Associates of Seattle

Seattle, Washington, 98101, 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; Precancerous Conditions; Neoplasms

Condition Hierarchy (Ancestors)

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

  Athenex, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• 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 15, 2017
• Primary Completion: May 7, 2018
• Study Completion: April 24, 2019
• Last Updated: March 10, 2021
• Results First Posted: March 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)