Atopic DermatitisPhase 2NCT05432596
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
A Phase 2 study testing ATI-1777 2.0% w/w, ATI-1777 1.0% w/w and ATI-1777 0.5% w/w in people with Atopic Dermatitis, run by Aclaris Therapeutics, Inc. at 32 sites in United States.
Trial summary
This is a Phase 2b study to determine the safety, tolerability, pharmacokinetic (PK), and efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ATI-1777 2.0% w/w, ATI-1777 1.0% w/w and ATI-1777 0.5% w/w
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 32 sitesUnited States
- Study dates
- 11 May 2022to 14 Nov 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
- Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent.
- Have at least a 6-month history of AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit.
Who cannot join
- Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
- Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments.
- Female patients who are pregnant, nursing, or planning to become pregnant during the study.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Aclaris Investigational Site
Arlington, Texas, 76011
Aclaris Investigational Site
Baton Rouge, Louisiana, 70809
Aclaris Investigational Site
Birmingham, Alabama, 35244
Aclaris Investigational Site
Bryant, Arkansas, 72022
Aclaris Investigational Site
Castle Rock, Colorado, 80109
Aclaris Investigational Site
Colorado Springs, Colorado, 80907
Aclaris Investigational Site
Dallas, Texas, 75230
Aclaris Investigational Site
Delray Beach, Florida, 33484
Aclaris Investigational Site
Encinitas, California, 92024
Aclaris Investigational Site
Encino, California, 91436
Aclaris Investigational Site
Greenville, South Carolina, 29615
Aclaris Investigational Site
Houma, Louisiana, 70364
Aclaris Investigational Site
Houston, Texas, 77004
Aclaris Investigational Site
Indianapolis, Indiana, 46250
Aclaris Investigational Site
Medford, Oregon, 97504
Aclaris Investigational Site
Miami, Florida, 33173
Aclaris Investigational Site
Miami Lakes, Florida, 33014
Aclaris Investigational Site
Murfreesboro, Tennessee, 37130
Aclaris Investigational Site
New Albany, Indiana, 47150
Aclaris Investigational Site
Normal, Illinois, 61761
Aclaris Investigational Site
North Little Rock, Arkansas, 72117
Aclaris Investigational Site
Oklahoma City, Oklahoma, 73118
Aclaris Investigational Site
Richmond, Virginia, 23233
Aclaris Investigational Site
Saint Joseph, Missouri, 64506
Aclaris Investigational Site
San Antonio, Texas, 78213
Aclaris Investigational Site
Sandy Springs, Georgia, 30328
Aclaris Investigational Site
Scottsdale, Arizona, 85255
Aclaris Investigational Site
Skokie, Illinois, 60077
Aclaris Investigational Site
Tampa, Florida, 33613
Aclaris Investigational Site
West Lafayette, Indiana, 47906
Aclaris Investigational Site
West Palm Beach, Florida, 33401
Aclaris Investigational Site
Wilmington, North Carolina, 28405
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (AD)
This is a Phase 2b study to determine the safety, tolerability, pharmacokinetic (PK), and efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- ATI-1777 2.0% w/w, ATI-1777 1.0% w/w, ATI-1777 0.5% w/w, 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.
ATI-1777 2.0% w/wDrug
ATI-1777 topical solution 2.0% w/w
ATI-1777 1.0% w/wDrug
ATI-1777 topical solution 1.0% w/w
ATI-1777 0.5% w/wDrug
ATI-1777 topical solution 0.5% w/w
VehicleDrug
Vehicle topical solution
| Study group | Role | What they receive |
|---|---|---|
| ATI-1777 topical solution 2.0% w/w (BID) | Experimental | ATI-1777 topical solution 2.0% w/w, twice daily Receives: Drug: ATI-1777 2.0% w/w |
| ATI-1777 topical solution 1.0% w/w (BID) | Experimental | ATI-1777 topical solution 1.0% w/w, twice daily Receives: Drug: ATI-1777 1.0% w/w |
| ATI-1777 topical solution 0.5% w/w (BID) | Experimental | ATI-1777 topical solution 0.5% w/w, twice daily Receives: Drug: ATI-1777 0.5% w/w |
| Vehicle (BID) | Placebo comparator | Vehicle topical solution, twice daily Receives: Drug: Vehicle |
| ATI-1777 topical solution 2.0% w/w (QD) | Experimental | ATI-1777 topical solution 2.0% w/w, once daily Receives: Drug: ATI-1777 2.0% w/w |
| Vehicle (QD) | Placebo comparator | Vehicle topical solution, once daily Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline to Day 28
Secondary outcomes (7)
Percentage change from baseline in EASI score at each post-baseline study visit
Measured: Baseline to Day 42
Proportion achieving Investigator's Global Assessment-Treatment Success (IGA-TS) defined as Validated Investigator Global Assessment (vIGA) score of 0 or 1 with an improvement in vIGA of at least 2 points from baseline at each post-baseline study visit.
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Measured: Baseline to Day 42
Proportion of patients who achieve 50%, 75%, and 90% improvement in EASI score (EASI 50, EASI 75, and EASI 90, respectively) at each post-baseline study visit
Measured: Baseline to Day 42
Change from baseline in vIGA score at each post-baseline study visit
Measured: Baseline to Day 42
Change from baseline in Body Surface Area (BSA) at each post-baseline study visit
BSA is defined as a percentage of the total body (0-100) that is affected by disease
Measured: Baseline to Day 42
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.
Measured: Baseline to Day 42
Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28
The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.study visit
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start11 May 2022
- Primary completion26 Oct 2023
- Study completion14 Nov 2023
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
- Randomized, Double-blind, Vehicle-controlled, Parallel-group Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432596
- Sponsor's protocol ID
- ATI-1777-AD-202
- Status last verified
- Oct 2024
- First submitted
- 1 Jun 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT05432596
- Acronym / sponsor ID
- ATI-1777-AD-202
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 27 Jun 2022 (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 2b study to determine the safety, tolerability, pharmacokinetic (PK), and efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized, Double-blind, Vehicle-controlled, Parallel-group Study
| Arm | Type | Receives |
|---|---|---|
| ATI-1777 topical solution 2.0% w/w (BID) | Experimental | Drug: ATI-1777 2.0% w/wATI-1777 topical solution 2.0% w/w, twice daily |
| ATI-1777 topical solution 1.0% w/w (BID) | Experimental | Drug: ATI-1777 1.0% w/wATI-1777 topical solution 1.0% w/w, twice daily |
| ATI-1777 topical solution 0.5% w/w (BID) | Experimental | Drug: ATI-1777 0.5% w/wATI-1777 topical solution 0.5% w/w, twice daily |
| Vehicle (BID) | Placebo comparator | Drug: VehicleVehicle topical solution, twice daily |
| ATI-1777 topical solution 2.0% w/w (QD) | Experimental | Drug: ATI-1777 2.0% w/wATI-1777 topical solution 2.0% w/w, once daily |
| Vehicle (QD) | Placebo comparator | Drug: VehicleVehicle topical solution, once daily |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
- Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent.
- Have at least a 6-month history of AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit.
Key exclusion criteria (3 listed)
- Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
- Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments.
- Female patients who are pregnant, nursing, or planning to become pregnant during the study.
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 |
|---|---|---|
| ATI-1777 2.0% w/wATI-1777 topical solution 2.0% w/w | Drug | ATI-1777 topical solution 2.0% w/w (BID), ATI-1777 topical solution 2.0% w/w (QD) |
| ATI-1777 1.0% w/wATI-1777 topical solution 1.0% w/w | Drug | ATI-1777 topical solution 1.0% w/w (BID) |
| ATI-1777 0.5% w/wATI-1777 topical solution 0.5% w/w | Drug | ATI-1777 topical solution 0.5% w/w (BID) |
| VehicleVehicle topical solution | Drug | Vehicle (BID), Vehicle (QD) |
Primary outcome
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
Time frame: Baseline to Day 28
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
7 secondary outcomes
Percentage change from baseline in EASI score at each post-baseline study visit
Time frame: Baseline to Day 42
Proportion achieving Investigator's Global Assessment-Treatment Success (IGA-TS) defined as Validated Investigator Global Assessment (vIGA) score of 0 or 1 with an improvement in vIGA of at least 2 points from baseline at each post-baseline study visit.
Time frame: Baseline to Day 42
Proportion of patients who achieve 50%, 75%, and 90% improvement in EASI score (EASI 50, EASI 75, and EASI 90, respectively) at each post-baseline study visit
Time frame: Baseline to Day 42
Change from baseline in vIGA score at each post-baseline study visit
Time frame: Baseline to Day 42
Change from baseline in Body Surface Area (BSA) at each post-baseline study visit
Time frame: Baseline to Day 42
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
Time frame: Baseline to Day 42
Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28
Time frame: Baseline to Day 28
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 26 Oct 2024.
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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.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATI-1777 2.0% w/w, ATI-1777 1.0% w/w and ATI-1777 0.5% w/w in people with Atopic Dermatitis, run by Aclaris Therapeutics, Inc. at 32 sites in United States.
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 3 inclusion and 3 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. 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?
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?
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28) (time frame: Baseline to Day 28). 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 26 Oct 2024.