Study in Subjects With Moderate Atopic Dermatitis

Last updated: November 4, 2019
Sponsor: Ralexar Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Rash

Allergy

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT03859986
ALX-101-ATOP-204
  • Ages > 12
  • All Genders

Study Summary

This is a Phase 2, randomized, double-blind, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of ALX-101 Gel 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 56 days in adult and adolescent subjects with moderate atopic dermatitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is at least 12 years of age at the time of consent.

  2. Subject has a clinical diagnosis of stable AD confirmed using the Hanafin and Rajkacriteria

  3. Subject has at least a 6-month history of atopic dermatitis and had no significantflares in atopic dermatitis for at least 4 weeks before Visit 1 (screening) (information obtained from medical chart or subject's physician or directly from thesubject).

  4. Subject must have active features of AD covering a minimum of 2% body surface area (BSA) (excluding scalp, face, genitals, palmar aspect of hands and plantar aspect offeet) at Visit 2 (baseline).

  5. Subject has moderate AD, defined as vIGA-AD™ score of 3 ("moderate"), at Visit 2 (baseline).

  6. Subject has an EASI score ≥ 5 at Visit 2 (baseline)

  7. Subject has been using an emollient (except those containing urea) daily for at least 1 week prior to Visit 2 (baseline), except on visit day before the visit. Subjectagrees to continue using that emollient, daily at the same frequency, on non-treatedareas, throughout the study but not the day of visits prior to the visit scheduledtime.

  8. Female subject of childbearing potential involved in any sexual intercourse that couldlead to her pregnancy, must have a negative serum pregnancy test at Visit 1, anegative urine pregnancy test at Visit 2 (baseline) and agree to use an approvedhighly effective contraceptive method for the entire study and up to 4 weeks followingthe final dose of study medication unless they are surgically sterile (hysterectomy,bilateral oophorectomy, or bilateral salpingectomy) or in menopausal state for atleast one year prior to screening (Visit 1)

  9. Male subject of childbearing potential agree to use an approved highly effectivemethod of contraception through study participation for 4 weeks following the finaldose of study medication

  10. Subject is in good general health and free of any known disease state or physicalcondition which, in the investigator's opinion, might impair evaluation of the ADbeing treated or which exposes the subject to an unacceptable risk by studyparticipation

  11. Subject is willing and able to follow all study instructions and to attend all studyvisits

  12. Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)/Assent Form (AF)

  13. Parent/guardian has the ability to understand, agree to and sign the study InformedConsent Form (ICF) prior to initiation of any protocol-related procedures asapplicable; subject has the ability to give assent in the Assent Form (AF)

  14. Informed Consent Form (ICF)/Assent Form (AF) must be obtained prior to initiation ofany protocol-related procedures.

Exclusion

Exclusion Criteria:

  1. Subject has spontaneously improving or rapidly deteriorating AD

  2. Subject has clinically infected AD

  3. Subject has any signs or symptoms associated with topical AD therapy which, in theinvestigator's opinion, might impair evaluation of the AD being treated or whichexposes the subject to an unacceptable risk by study participation

  4. Subject has any clinically significant laboratory abnormality, medical condition orphysical/vital signs abnormality that would, in the opinion of the investigator, putthe subject at undue risk or interfere with interpretation of study results

  5. Subjects with a past history of cancer or lymphoproliferative disease within 5 yearsprior to Visit 2 (baseline) (subjects with successfully treated non-metastaticcutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ ofthe cervix are not to be excluded)

  6. Subject is known to have immune deficiency or is immunocompromised

  7. Subject has a known history of chronic infectious disease (e.g., hepatitis B,hepatitis C, or infection with human immunodeficiency virus)

  8. Subject had major surgery within 8 weeks prior to Visit 2 (baseline) or has a majorsurgery planned during the study.

  9. Topical medications, including but not limited to, topical corticosteroids,crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurininhibitors, tars, bleach, antimicrobials, medical devices and bleach bath within 2weeks prior to Visit 2 (baseline)

  10. Subject has used any non-medicated topical product (e.g., lotions, gels, creams,ointments) in the planned treatment area 4 hours prior to Visit 2 (baseline)

  11. Subject has used the following systemic treatments (other than biologics) that couldaffect atopic dermatitis less than 4 weeks prior to Visit 2 (baseline) (e.g.,retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids) within 4 weeks prior toScreening. Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye andear drops containing corticosteroids are also allowed.

  12. Subject has used any systemic antibiotics within 2 weeks prior to Visit 2 (baseline)

  13. Subject has used hydroxyzine or diphenhydramine within 1 week prior to Visit 2 (baseline), unless on a stable dose.

  14. Subject has used topical doxepin within 1 week prior to Visit 2 (baseline).

  15. Subject has used topical products containing urea within 1 week prior to Visit 2 (baseline)

  16. Subject has used or is planning to use any phototherapy (e.g., UVA/UVB therapy, orPUVA therapy), excessive natural or artificial ultraviolent radiation (e.g., sunlight,tanning beds) which, in the investigator's opinion, might affect AD within 4 weeksprior to Visit 2 (baseline)

  17. Biologic therapies (e.g., Dupilumab) within 12 weeks or 5 half-lives prior to Visit 2 (baseline)

  18. Subject has a history of sensitivity to any of the ingredients in the studymedications

  19. Subject has any known concomitant dermatologic or medical condition which, in theinvestigator's opinion, might impair evaluation of the areas of AD being treated orwhich exposes the subject to an unacceptable risk by study participation (e.g.,psoriasis, rosacea, lichen planus, lichen simplex chronicus,…)

  20. Subject is a female who is breastfeeding, pregnant, or who is planning to becomepregnant during the study.

  21. Subject has a known history of clinically significant drug or alcohol abuse in thelast year prior to Visit 2 (baseline)

  22. Subject has participated in a nonbiological investigational drug trial in whichadministration of an investigational study medication occurred within 4 weeks prior toVisit 2 (baseline)

Study Design

Total Participants: 124
Study Start date:
March 08, 2019
Estimated Completion Date:
January 31, 2020

Study Description

The main objectives of this study are to:

  • Evaluate the safety of ALX-101 Gel 5% when applied topically twice daily in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle

  • Evaluate the efficacy of ALX-101 Gel 5% when applied topically twice daily in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle

Connect with a study center

  • Ralexar Investigational Site 20

    Toronto, Ontario M9V4B4
    Canada

    Site Not Available

  • Ralexar Investigational Site 11

    Montréal, Quebec H2K4L5
    Canada

    Site Not Available

  • Ralexar Investigational Site 10

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Ralexar Investigational Site 5

    Los Angeles, California 90045
    United States

    Site Not Available

  • Ralexar Investigational Site 3

    Aventura, Florida 33180
    United States

    Site Not Available

  • Ralexar Investigational Site 2

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Ralexar Investigational Site 22

    Miami, Florida 33147
    United States

    Site Not Available

  • Ralexar Investigational Site 18

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Ralexar Investigational Site 6

    Sanford, Florida 32771
    United States

    Site Not Available

  • Ralexar Investigational Site 13

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Ralexar Investigational Site 7

    Boise, Idaho 83713
    United States

    Site Not Available

  • Ralexar Investigational Site 21

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Ralexar Investigational Site 1

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Ralexar Investigational Site 17

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Ralexar Investigational Site 12

    Las Vegas, Nevada 89177
    United States

    Site Not Available

  • Ralexar Investigational Site 14

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Ralexar Investigational Site 8

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Ralexar Investigational Site 9

    Oklahoma City, Oklahoma 73118
    United States

    Site Not Available

  • Ralexar Investigational Site 19

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • Ralexar Investigational Site 16

    Austin, Texas 78745
    United States

    Site Not Available

  • Ralexar Investigational Site 4

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Ralexar Investigational Site 15

    Seattle, Washington 98101
    United States

    Site Not Available

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