Atopic Dermatitis EczemaPhase 2NCT03859986
Study in Subjects With Moderate Atopic Dermatitis
A Phase 2 study testing ALX-101 Gel 5% in people with Atopic Dermatitis Eczema, run by Ralexar Therapeutics, Inc. at 22 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- ALX-101 Gel 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 8 Mar 2019to Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States20 sites
Ralexar Investigational Site 16
Austin, Texas, 78745
Ralexar Investigational Site 3
Aventura, Florida, 33180
Ralexar Investigational Site 14
Beachwood, Ohio, 44122
Ralexar Investigational Site 10
Beverly Hills, California, 90212
Ralexar Investigational Site 7
Boise, Idaho, 83713
Ralexar Investigational Site 8
Fairborn, Ohio, 45324
Ralexar Investigational Site 21
Gurnee, Illinois, 60031
Ralexar Investigational Site 1
Indianapolis, Indiana, 46250
Ralexar Investigational Site 2
Jacksonville, Florida, 32256
Ralexar Investigational Site 12
Las Vegas, Nevada, 89177
Ralexar Investigational Site 5
Los Angeles, California, 90045
Ralexar Investigational Site 17
Louisville, Kentucky, 40202
Ralexar Investigational Site 13
Marietta, Georgia, 30060
Ralexar Investigational Site 22
Miami, Florida, 33147
Ralexar Investigational Site 9
Oklahoma City, Oklahoma, 73118
Ralexar Investigational Site 18
Pinellas Park, Florida, 33781
Ralexar Investigational Site 4
San Antonio, Texas, 78213
Ralexar Investigational Site 6
Sanford, Florida, 32771
Ralexar Investigational Site 15
Seattle, Washington, 98101
Ralexar Investigational Site 19
Spartanburg, South Carolina, 29307
Canada2 sites
Ralexar Investigational Site 11
Montreal, Quebec, H2K4L5
Ralexar Investigational Site 20
Toronto, Ontario, M9V4B4
About this study
Official title: 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
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
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- ALX-101 Gel Vehicle, ALX-101 Gel 5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX-101 Gel VehicleDrug
ALX-101 Gel Vehicle
ALX-101 Gel 5%Drug
ALX-101 Gel 5%
| Study group | Role | What they receive |
|---|---|---|
| ALX-101 Gel 5% | Experimental | ALX-101 Gel 5% applied topically twice daily for 56 days Receives: Drug: ALX-101 Gel 5% |
| ALX-101 Gel Vehicle | Placebo comparator | ALX-101 Gel Vehicle applied topically twice daily for 56 days Receives: Drug: ALX-101 Gel Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area Severity Index (EASI)
Mean change from baseline in EASI score at Week 8
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start8 Mar 2019
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ralexar Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859986
- Sponsor's protocol ID
- ALX-101-ATOP-204
- Status last verified
- Nov 2019
- First submitted
- 28 Feb 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03859986
- Acronym / sponsor ID
- ALX-101-ATOP-204
- Conditions
- Atopic Dermatitis Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ralexar Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALX-101 Gel 5% | Experimental | Drug: ALX-101 Gel 5%ALX-101 Gel 5% applied topically twice daily for 56 days |
| ALX-101 Gel Vehicle | Placebo comparator | Drug: ALX-101 Gel VehicleALX-101 Gel Vehicle applied topically twice daily for 56 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALX-101 Gel VehicleALX-101 Gel Vehicle | Drug | ALX-101 Gel Vehicle |
| ALX-101 Gel 5%ALX-101 Gel 5% | Drug | ALX-101 Gel 5% |
Primary outcome
Eczema Area Severity Index (EASI)
Time frame: Day 57
Mean change from baseline in EASI score at Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALX-101 Gel 5% in people with Atopic Dermatitis Eczema, run by Ralexar Therapeutics, Inc. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area Severity Index (EASI) (time frame: Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.