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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03285490
Recruitment Status : Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Athenex, Inc.

Brief Summary:
This Phase III study is designed to evaluate the activity and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containg 4-8 stable, clinically typical Actinic Keratosis lesions on the face or scalp.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: KX2-391 Ointment 1% Drug: Placebo Phase 3

Detailed Description:

This study will be a double-blinded, multicenter, activity, and safety study of KX2-391 Ointment administered topically to the face or scalp of subjects with actinic keratosis.

The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible subjects will receive X consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations will be performed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will test KX2-391 Ointment 1% against a placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All Central Vendors and the sponsor will be masked. The sponsor will unblind at the end of Day 57.
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 29, 2019

Arm Intervention/treatment
Experimental: KX2-391 Ointment 1%
KX2-391 Ointment will be applied once daily for X consecutive days on the face or scalp
Drug: KX2-391 Ointment 1%
The experimental drug, KX2-391 Ointment 1% will be used in subjects with Clinically typical AK on the face or scalp.

Placebo Comparator: Placebo
The Vehicle Ointment will be applied once daily for X consecutive days on the face or scalp
Drug: Placebo
Vehicle Ointment wil be used in subjects with Clinically typical AK on the face or scalp.




Primary Outcome Measures :
  1. Complete response rate [ Time Frame: 57 Days ]
    Efficacy will be evaluated by the proportion of subjects achieving complete clearance of all AK in the selected area in the study drug group versus the placebo group.


Secondary Outcome Measures :
  1. Local Skin Reactions [ Time Frame: 15 Months ]
    To evaluate the safety of KX2-391 Ointment 1% by the proportion of local skin reactions

  2. Adverse Events [ Time Frame: 15 Months ]
    To evaluate the safety of KX2-391 Ointment 1% by the proportion of adverse events

  3. Abnormal Laboratory Assessments [ Time Frame: 15 Months ]
    To evaluate the safety of KX2-391 Ointment 1% by the proportion of abnormal laboratory assessments

  4. Partial Response [ Time Frame: 57 Days ]
    Partial response is defined as ≥75% clearance of AK lesions in the selected treatment area, comparing the study drug group versus the placebo group

  5. Reduction of AK lesions [ Time Frame: 57 Days ]
    The proportion of AK lesions which reduce in the selected area.

  6. Complete response rate [ Time Frame: 12 months ]
    Efficacy will be evaluated by the proportion of subjects achieving complete clearance of all AK in the selected area in the study drug group versus the placebo group in recurrence follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Males and females ≥18 years old
  2. A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions
  3. Subjects who in the judgment of the Investigator, are in good general health
  4. Females must be postmenopausal (>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.
  5. 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.
  6. All subjects must agree 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 UV exposure
  8. Able to comprehend and are 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 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 (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
  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 (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the subject 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 subject to unacceptable risk by study participation
  12. Females who are 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 is longer, before dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285490


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Sponsors and Collaborators
Athenex, Inc.
Investigators
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Study Chair: Jane Fang, MD Athenex, Inc.

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Responsible Party: Athenex, Inc.
ClinicalTrials.gov Identifier: NCT03285490     History of Changes
Other Study ID Numbers: KX01-AK-004
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Athenex, Inc.:
Actinic Keratosis
Keratosis
Keratosis, Actinic
Precancerous Conditions
Neoplasms
Sun Damaged Skin
Actinic Keratoses

Additional relevant MeSH terms:
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Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms