Atopic DermatitisPhase 2NCT04339985
Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD
A Phase 2 study testing ATx201 in people with Atopic Dermatitis, run by UNION therapeutics at 10 sites in 3 countries.
Trial summary
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ATx201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 22 Oct 2019to 31 Mar 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of AD using the Hanifin and Rajka criteria and minimum 1-year history with a current IGA score of 2 or 3 and treatable BSA ≥5% but ≤36% (treatable BSA includes all lesions present at screening except scalp)
- Age ≥12 and <60 years
- Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Day 1.
- Subject or LAR able to understand and provide signed informed consent. Assent is also required of adolescents.
- Normally active and otherwise in good health by medical history and physical examination
Who cannot join
- Actively infected AD (ie, requiring antimicrobial therapy as determined by the investigator)
- Acute exacerbation or flare in the 4 weeks prior to the Day 1 visit that necessitates treatment with a high potency corticosteroid (such as clobetasol propionate or betamethasone dipropionate), or antibiotics, or prednisolone
- Enrollment in an ATx201 study in the previous 6 months
- Allergy or history of significant adverse reaction to ATx201 or related compounds, or to any of the excipients used
- Underlying skin condition that may interfere with the placement of study treatment or impede clinical evaluations (including active Herpes simplex)
- Current acute or chronic condition unless considered clinically irrelevant and stable by the investigator
Show all 10Show fewer
- The presence of a condition the investigator believes would interfere with the ability to provide informed consent or assent, or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk
- Unable or unwilling to comply with study procedures
- Exposure to any IP within 30 days prior to randomization
- There are also some specific criteria related to prior or concomitant therapy
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Poland5 sites
UNION therapeutics Investigational Site 6
Bydgoszcz
UNION therapeutics Investigational Site 10
Lodz
UNION therapeutics Investigational Site 7
Nowy Targ
UNION therapeutics Investigational Site 9
Skierniewice
UNION therapeutics Investigational Site 8
Wroclaw
Bulgaria4 sites
UNION therapeutics Investigational Site 5
Pleven
UNION therapeutics Investigational Site 2
Sofia
UNION therapeutics Investigational Site 3
Sofia
UNION therapeutics Investigational Site 4
Sofia
About this study
Official title: A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis
Read the detailed description
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis.
Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201 OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive blocks in 1:1:1 ratio for the active groups and vehicle.
Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.
- Conditions
- Atopic Dermatitis
- Being tested
- ATx201, ATx201 OINTMENT vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATx201Drug
Also called ATx201 OINTMENT
Topical
ATx201 OINTMENT vehicleDrug
ATx201 OINTMENT vehicle
| Study group | Role | What they receive |
|---|---|---|
| ATx201 OINTMENT 4% | Experimental | ATx201 OINTMENT 4% Receives: Drug: ATx201 |
| ATx201 OINTMENT 7% | Experimental | ATx201 OINTMENT 7% Receives: Drug: ATx201 |
| ATx201 OINTMENT vehicle | Experimental | ATx201 OINTMENT vehicle Receives: Drug: ATx201 OINTMENT vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
EASI mean change from baseline at Week 6
Measured: Baseline to Week 6
Secondary outcomes (3)
Investigator Global Assessment (IGA) success
IGA success with defined improvement from baseline; success defined as clear (0) or almost clear (1) with ≥2 grade improvement from baseline
Measured: Baseline to Week 6
change from baseline in Investigator Global Assessment (IGA) scoring
Distribution of IGA scores and change from baseline
Measured: Baseline to Week 6
Mean change from baseline in Target lesion Total Sign Score (TSS)
Target lesion TSS mean change from baseline
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start22 Oct 2019
- Primary completion22 Oct 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Model description
- Subjects will be randomly assigned by using Interactive Web Response System (IWRS) to one of three treatment groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNION therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Andres, Dr., Study chair, UNION therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339985
- Sponsor's protocol ID
- ATx201-207
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04339985
- Acronym / sponsor ID
- ATx201-207
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- UNION therapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 9 Apr 2020 (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, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis
Detailed description
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis.
Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201 OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive blocks in 1:1:1 ratio for the active groups and vehicle.
Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Subjects will be randomly assigned by using Interactive Web Response System (IWRS) to one of three treatment groups
| Arm | Type | Receives |
|---|---|---|
| ATx201 OINTMENT 4% | Experimental | Drug: ATx201ATx201 OINTMENT 4% |
| ATx201 OINTMENT 7% | Experimental | Drug: ATx201ATx201 OINTMENT 7% |
| ATx201 OINTMENT vehicle | Experimental | Drug: ATx201 OINTMENT vehicleATx201 OINTMENT vehicle |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of AD using the Hanifin and Rajka criteria and minimum 1-year history with a current IGA score of 2 or 3 and treatable BSA ≥5% but ≤36% (treatable BSA includes all lesions present at screening except scalp)
- Age ≥12 and <60 years
- Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Day 1.
- Subject or LAR able to understand and provide signed informed consent. Assent is also required of adolescents.
- Normally active and otherwise in good health by medical history and physical examination
Key exclusion criteria (10 listed)
- Actively infected AD (ie, requiring antimicrobial therapy as determined by the investigator)
- Acute exacerbation or flare in the 4 weeks prior to the Day 1 visit that necessitates treatment with a high potency corticosteroid (such as clobetasol propionate or betamethasone dipropionate), or antibiotics, or prednisolone
- Enrollment in an ATx201 study in the previous 6 months
- Allergy or history of significant adverse reaction to ATx201 or related compounds, or to any of the excipients used
- Underlying skin condition that may interfere with the placement of study treatment or impede clinical evaluations (including active Herpes simplex)
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 |
|---|---|---|
| ATx201Also: ATx201 OINTMENTTopical | Drug | ATx201 OINTMENT 4%, ATx201 OINTMENT 7% |
| ATx201 OINTMENT vehicleATx201 OINTMENT vehicle | Drug | ATx201 OINTMENT vehicle |
Primary outcome
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
Time frame: Baseline to Week 6
EASI mean change from baseline at Week 6
3 secondary outcomes
Investigator Global Assessment (IGA) success
Time frame: Baseline to Week 6
change from baseline in Investigator Global Assessment (IGA) scoring
Time frame: Baseline to Week 6
Mean change from baseline in Target lesion Total Sign Score (TSS)
Time frame: Baseline to Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Philippe Andres, Dr. study chair
UNION therapeutics
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATx201 in people with Atopic Dermatitis, run by UNION therapeutics at 10 sites in 3 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland, Bulgaria, Denmark. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI) (time frame: Baseline to Week 6). 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 29 Apr 2021.