Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
124 participants
INTERVENTIONAL
2019-03-08
2020-01-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ALX-101 Gel 5%
ALX-101 Gel 5% applied topically twice daily for 56 days
ALX-101 Gel 5%
ALX-101 Gel 5%
ALX-101 Gel Vehicle
ALX-101 Gel Vehicle applied topically twice daily for 56 days
ALX-101 Gel Vehicle
ALX-101 Gel Vehicle
Interventions
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ALX-101 Gel Vehicle
ALX-101 Gel Vehicle
ALX-101 Gel 5%
ALX-101 Gel 5%
Eligibility Criteria
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Inclusion Criteria
2. Subject has a clinical diagnosis of stable AD confirmed using the Hanafin and Rajka criteria
3. Subject has at least a 6-month history of atopic dermatitis and had no significant flares in atopic dermatitis for at least 4 weeks before Visit 1 (screening) (information obtained from medical chart or subject's physician or directly from the subject).
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 of feet) 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. Subject agrees to continue using that emollient, daily at the same frequency, on non-treated areas, throughout the study but not the day of visits prior to the visit scheduled time.
8. Female subject of childbearing potential involved in any sexual intercourse that could lead to her pregnancy, must have a negative serum pregnancy test at Visit 1, a negative urine pregnancy test at Visit 2 (baseline) and agree to use an approved highly effective contraceptive method for the entire study and up to 4 weeks following the final dose of study medication unless they are surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or in menopausal state for at least one year prior to screening (Visit 1)
9. Male subject of childbearing potential agree to use an approved highly effective method of contraception through study participation for 4 weeks following the final dose of study medication
10. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation
11. Subject is willing and able to follow all study instructions and to attend all study visits
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 Informed Consent Form (ICF) prior to initiation of any protocol-related procedures as applicable; 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 of any protocol-related procedures.
Exclusion Criteria
2. Subject has clinically infected AD
3. Subject has any signs or symptoms associated with topical AD therapy which, in the investigator's opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation
4. Subject has any clinically significant laboratory abnormality, medical condition or physical/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results
5. Subjects with a past history of cancer or lymphoproliferative disease within 5 years prior to Visit 2 (baseline) (subjects with successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the 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 major surgery planned during the study.
9. Topical medications, including but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, tars, bleach, antimicrobials, medical devices and bleach bath within 2 weeks 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 could affect 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 to Screening. Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear 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, or PUVA therapy), excessive natural or artificial ultraviolent radiation (e.g., sunlight, tanning beds) which, in the investigator's opinion, might affect AD within 4 weeks prior 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 study medications
19. Subject has any known concomitant dermatologic or medical condition which, in the investigator's opinion, might impair evaluation of the areas of AD being treated or which 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 become pregnant during the study.
21. Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Visit 2 (baseline)
22. Subject has participated in a nonbiological investigational drug trial in which administration of an investigational study medication occurred within 4 weeks prior to Visit 2 (baseline)
12 Years
ALL
No
Sponsors
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Ralexar Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Ralexar Investigational Site 10
Beverly Hills, California, United States
Ralexar Investigational Site 5
Los Angeles, California, United States
Ralexar Investigational Site 3
Aventura, Florida, United States
Ralexar Investigational Site 2
Jacksonville, Florida, United States
Ralexar Investigational Site 22
Miami, Florida, United States
Ralexar Investigational Site 18
Pinellas Park, Florida, United States
Ralexar Investigational Site 6
Sanford, Florida, United States
Ralexar Investigational Site 13
Marietta, Georgia, United States
Ralexar Investigational Site 7
Boise, Idaho, United States
Ralexar Investigational Site 21
Gurnee, Illinois, United States
Ralexar Investigational Site 1
Indianapolis, Indiana, United States
Ralexar Investigational Site 17
Louisville, Kentucky, United States
Ralexar Investigational Site 12
Las Vegas, Nevada, United States
Ralexar Investigational Site 14
Beachwood, Ohio, United States
Ralexar Investigational Site 8
Fairborn, Ohio, United States
Ralexar Investigational Site 9
Oklahoma City, Oklahoma, United States
Ralexar Investigational Site 19
Spartanburg, South Carolina, United States
Ralexar Investigational Site 16
Austin, Texas, United States
Ralexar Investigational Site 4
San Antonio, Texas, United States
Ralexar Investigational Site 15
Seattle, Washington, United States
Ralexar Investigational Site 20
Toronto, Ontario, Canada
Ralexar Investigational Site 11
Montreal, Quebec, Canada
Countries
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Other Identifiers
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ALX-101-ATOP-204
Identifier Type: -
Identifier Source: org_study_id
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