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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M9V4B4
        • Ralexar Investigational Site 20
    • Quebec
      • Montréal, Quebec, Canada, H2K4L5
        • Ralexar Investigational Site 11
  • United States
    • California
      • Beverly Hills, California, United States, 90212
        • Ralexar Investigational Site 10
      • Los Angeles, California, United States, 90045
        • Ralexar Investigational Site 5
    • Florida
      • Aventura, Florida, United States, 33180
        • Ralexar Investigational Site 3
      • Jacksonville, Florida, United States, 32256
        • Ralexar Investigational Site 2
      • Miami, Florida, United States, 33147
        • Ralexar Investigational Site 22
      • Pinellas Park, Florida, United States, 33781
        • Ralexar Investigational Site 18
      • Sanford, Florida, United States, 32771
        • Ralexar Investigational Site 6
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Ralexar Investigational Site 13
    • Idaho
      • Boise, Idaho, United States, 83713
        • Ralexar Investigational Site 7
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Ralexar Investigational Site 21
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Ralexar Investigational Site 1
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Ralexar Investigational Site 17
    • Nevada
      • Las Vegas, Nevada, United States, 89177
        • Ralexar Investigational Site 12
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Ralexar Investigational Site 14
      • Fairborn, Ohio, United States, 45324
        • Ralexar Investigational Site 8
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Ralexar Investigational Site 9
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
        • Ralexar Investigational Site 19
    • Texas
      • Austin, Texas, United States, 78745
        • Ralexar Investigational Site 16
      • San Antonio, Texas, United States, 78213
        • Ralexar Investigational Site 4
    • Washington
      • Seattle, Washington, United States, 98101
        • Ralexar Investigational Site 15

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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:

  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 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)

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ALX-101 Gel 5%
ALX-101 Gel 5% applied topically twice daily for 56 days
Drug: ALX-101 Gel 5%
ALX-101 Gel 5%
PLACEBO_COMPARATOR: ALX-101 Gel Vehicle
ALX-101 Gel Vehicle applied topically twice daily for 56 days
Drug: ALX-101 Gel Vehicle
ALX-101 Gel Vehicle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eczema Area Severity Index (EASI)
Time Frame: Day 57
Mean change from baseline in EASI score at Week 8
Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ralexar Therapeutics, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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