CClinicalTrials.gg
Status unknownNCT03859986Updated Nov 5, 2019

Study in Subjects With Moderate Atopic Dermatitis

A Phase 2 interventional study of ALX-101 Gel Vehicle and ALX-101 Gel 5% in Atopic Dermatitis Eczema, sponsored by Ralexar Therapeutics, Inc.. Status unknown at 22 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-11-05.

Sponsored by Ralexar Therapeutics, Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

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

Read the 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
02

Conditions studied

  • Atopic Dermatitis Eczema
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 124 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Ralexar Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    ALX-101 Gel 5%

    ALX-101 Gel 5% applied topically twice daily for 56 days

    Drug: 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

Interventions

  • DrugALX-101 Gel Vehicle

    ALX-101 Gel Vehicle

  • DrugALX-101 Gel 5%

    ALX-101 Gel 5%

06

What researchers measure

Primary outcomes

  1. Eczema Area Severity Index (EASI)

    Mean change from baseline in EASI score at Week 8

    Time frame: Day 57

07

Study locations

22 sites
  • Ralexar Investigational Site 10
    Beverly Hills, California 90212, United States
  • Ralexar Investigational Site 5
    Los Angeles, California 90045, United States
  • Ralexar Investigational Site 3
    Aventura, Florida 33180, United States
  • Ralexar Investigational Site 2
    Jacksonville, Florida 32256, United States
  • Ralexar Investigational Site 22
    Miami, Florida 33147, United States
  • Ralexar Investigational Site 18
    Pinellas Park, Florida 33781, United States
  • Ralexar Investigational Site 6
    Sanford, Florida 32771, United States
  • Ralexar Investigational Site 13
    Marietta, Georgia 30060, United States
  • Ralexar Investigational Site 7
    Boise, Idaho 83713, United States
  • Ralexar Investigational Site 21
    Gurnee, Illinois 60031, United States
  • Ralexar Investigational Site 1
    Indianapolis, Indiana 46250, United States
  • Ralexar Investigational Site 17
    Louisville, Kentucky 40202, United States
  • Ralexar Investigational Site 12
    Las Vegas, Nevada 89177, United States
  • Ralexar Investigational Site 14
    Beachwood, Ohio 44122, United States
  • Ralexar Investigational Site 8
    Fairborn, Ohio 45324, United States
  • Ralexar Investigational Site 9
    Oklahoma City, Oklahoma 73118, United States
  • Ralexar Investigational Site 19
    Spartanburg, South Carolina 29307, United States
  • Ralexar Investigational Site 16
    Austin, Texas 78745, United States
  • Ralexar Investigational Site 4
    San Antonio, Texas 78213, United States
  • Ralexar Investigational Site 15
    Seattle, Washington 98101, United States
  • Ralexar Investigational Site 20
    Toronto, Ontario M9V4B4, Canada
  • Ralexar Investigational Site 11
    Montréal, Quebec H2K4L5, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03859986
Lead sponsor
Ralexar Therapeutics, Inc.
Responsible party
Sponsor
First posted
Mar 1, 2019
Start date
Mar 8, 2019
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
Nov 5, 2019

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion