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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 (AK003)

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: NCT03285477
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Athenex, Inc.

Tracking Information
First Submitted Date  ICMJE September 7, 2017
First Posted Date  ICMJE September 18, 2017
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE September 15, 2017
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03285477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • Local Skin Reactions [ Time Frame: 15 Months ]
    To evaluate the safety of KX2-391 Ointment 1% by the proportion of local skin reactions
  • Adverse Events [ Time Frame: 15 Months ]
    To evaluate the safety of KX2-391 Ointment 1% by the proportion of adverse events
  • Abnormal Laboratory Assessments [ Time Frame: 15 Months ]
    To evaluate the safety of KX2-391 Ointment 1% by the proportion of abnormal laboratory assessments
  • 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
  • Reduction of AK lesions [ Time Frame: 57 Days ]
    The proportion of AK lesions which reduce in the selected area.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Actinic Keratoses
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    Vehicle Ointment wil be used in subjects with Clinically typical AK on the face or scalp.
Study Arms  ICMJE
  • Experimental: KX2-391 Ointment 1%
    KX2-391 Ointment will be applied once daily for X consecutive days on the face or scalp
    Intervention: Drug: KX2-391 Ointment 1%
  • Placebo Comparator: Placebo
    The Vehicle Ointment will be applied once daily for X consecutive days on the face or scalp
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 28, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03285477
Other Study ID Numbers  ICMJE KX01-AK-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Athenex, Inc.
Study Sponsor  ICMJE Athenex, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jane Fang, MD Athenex, Inc.
PRS Account Athenex, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP