- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03859986
Study in Subjects With Moderate Atopic Dermatitis
November 4, 2019 updated by: Ralexar Therapeutics, Inc.
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study To Evaluate The Safety And Efficacy Of ALX-101 Topical Gel Administered Twice Daily In Adult And Adolescent Subjects With Moderate Atopic Dermatitis
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M9V4B4
- Ralexar Investigational Site 20
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Quebec
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Montréal, Quebec, Canada, H2K4L5
- Ralexar Investigational Site 11
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California
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Beverly Hills, California, United States, 90212
- Ralexar Investigational Site 10
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Los Angeles, California, United States, 90045
- Ralexar Investigational Site 5
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Florida
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Aventura, Florida, United States, 33180
- Ralexar Investigational Site 3
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Jacksonville, Florida, United States, 32256
- Ralexar Investigational Site 2
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Miami, Florida, United States, 33147
- Ralexar Investigational Site 22
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Pinellas Park, Florida, United States, 33781
- Ralexar Investigational Site 18
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Sanford, Florida, United States, 32771
- Ralexar Investigational Site 6
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Georgia
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Marietta, Georgia, United States, 30060
- Ralexar Investigational Site 13
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Idaho
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Boise, Idaho, United States, 83713
- Ralexar Investigational Site 7
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Illinois
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Gurnee, Illinois, United States, 60031
- Ralexar Investigational Site 21
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Indiana
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Indianapolis, Indiana, United States, 46250
- Ralexar Investigational Site 1
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Kentucky
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Louisville, Kentucky, United States, 40202
- Ralexar Investigational Site 17
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Nevada
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Las Vegas, Nevada, United States, 89177
- Ralexar Investigational Site 12
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Ohio
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Beachwood, Ohio, United States, 44122
- Ralexar Investigational Site 14
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Fairborn, Ohio, United States, 45324
- Ralexar Investigational Site 8
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73118
- Ralexar Investigational Site 9
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South Carolina
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Spartanburg, South Carolina, United States, 29307
- Ralexar Investigational Site 19
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Texas
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Austin, Texas, United States, 78745
- Ralexar Investigational Site 16
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San Antonio, Texas, United States, 78213
- Ralexar Investigational Site 4
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Washington
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Seattle, Washington, United States, 98101
- Ralexar Investigational Site 15
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is at least 12 years of age at the time of consent.
- Subject has a clinical diagnosis of stable AD confirmed using the Hanafin and Rajka criteria
- 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).
- 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).
- Subject has moderate AD, defined as vIGA-AD™ score of 3 ("moderate"), at Visit 2 (baseline).
- Subject has an EASI score ≥ 5 at Visit 2 (baseline)
- 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.
- 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)
- 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
- 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
- Subject is willing and able to follow all study instructions and to attend all study visits
- Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)/Assent Form (AF)
- 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)
- Informed Consent Form (ICF)/Assent Form (AF) must be obtained prior to initiation of any protocol-related procedures.
Exclusion Criteria:
- Subject has spontaneously improving or rapidly deteriorating AD
- Subject has clinically infected AD
- 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
- 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
- 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)
- Subject is known to have immune deficiency or is immunocompromised
- Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus)
- Subject had major surgery within 8 weeks prior to Visit 2 (baseline) or has a major surgery planned during the study.
- 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)
- 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)
- 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.
- Subject has used any systemic antibiotics within 2 weeks prior to Visit 2 (baseline)
- Subject has used hydroxyzine or diphenhydramine within 1 week prior to Visit 2 (baseline), unless on a stable dose.
- Subject has used topical doxepin within 1 week prior to Visit 2 (baseline).
- Subject has used topical products containing urea within 1 week prior to Visit 2 (baseline)
- 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)
- Biologic therapies (e.g., Dupilumab) within 12 weeks or 5 half-lives prior to Visit 2 (baseline)
- Subject has a history of sensitivity to any of the ingredients in the study medications
- 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,…)
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Visit 2 (baseline)
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: ALX-101 Gel 5%
ALX-101 Gel 5% applied topically twice daily for 56 days
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ALX-101 Gel 5%
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PLACEBO_COMPARATOR: ALX-101 Gel Vehicle
ALX-101 Gel Vehicle applied topically twice daily for 56 days
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ALX-101 Gel Vehicle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Eczema Area Severity Index (EASI)
Time Frame: Day 57
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Mean change from baseline in EASI score at Week 8
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Day 57
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 8, 2019
Primary Completion (ANTICIPATED)
January 1, 2020
Study Completion (ANTICIPATED)
January 1, 2020
Study Registration Dates
First Submitted
February 28, 2019
First Submitted That Met QC Criteria
February 28, 2019
First Posted (ACTUAL)
March 1, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 5, 2019
Last Update Submitted That Met QC Criteria
November 4, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALX-101-ATOP-204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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