Atopic DermatitisPhase 2NCT07011706
ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing ATI-045 in people with Atopic Dermatitis and Atopic, run by Aclaris Therapeutics, Inc. at 60 sites in 2 countries.
Trial summary
This study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis, Atopic, Dermatitis
- What is being tested?
- ATI-045
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 60 sitesin 2 countries
- Study dates
- 30 May 2025to 24 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic atopic dermatitis that has been present for ≥ 6 months before the screening visit and with no significant AD flares during the past 4 weeks before screening
- Have active moderate to severe AD at screening and baseline visits
- EASI score ≥ 16 and ≥10% BSA at the screening and baseline visits
- History of inadequate response to treatment for AD with topical medications; or determination that topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks)
- Patient applied a stable dose of non-medicated topical moisturizer (ideally once or twice daily) for ≥ 7 days prior to the baseline visit and agrees to continue use during study
Who cannot join
- Treatment with any of the following:
- Intravenous immunoglobulin within 12 weeks prior to the baseline visit (W0D1)
- Systemic antibiotics within 2 weeks prior to the baseline visit (W0D1)
- Topical antibiotics within 1 week prior the baseline visit (W0D1)
- Topical medicated treatment that could affect atopic dermatitis should be prohibited for at least 2 weeks prior to baseline visit. Example: topical corticosteroids, crisaborole, calcineurin inhibitors, ruxolitinib, roflumilast, tars, antimicrobials, medical devices, and bleach baths.
- Topical products containing urea within 1 week prior to baseline visit (W0D1)
Show all 14Show fewer
- Doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (W0D1)
- Patient has used systemic treatments (other than biologics) that could affect AD less than 4 weeks or 5 half-lives (whichever is longer) prior to the baseline visit (W0D1), including, but not limited to, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids, baricitinib, upadacitinib, and abrocitinib.
- Biologics for AD treatments (such as dupilumab, tralokinumab, lebrikizumab, investigational biologics) within 5 half- lives or 12 weeks, whichever is longer prior to the baseline visit (W0D1)
- An investigational drug (non-biologic) within 4 weeks or within 5 half-lives (if known), whichever is longer prior to the baseline visit (W0D1)
- Phototherapy and photochemotherapy for AD within 4 weeks prior to the baseline visit (W0D1)
- A live (attenuated) vaccine within 12 weeks prior to the baseline visit (W0D1)
- History of anaphylaxis following biologic therapy.
- History of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine.
Trial locations and contacts
60 sites in 2 countries.
60 sites in 2 countries
United States53 sites
Aclaris Clinical Site
Ann Arbor, Michigan, 48103
Aclaris Clinical Site
Atlanta, Georgia, 30315
Aclaris Study Site
Auburn Hills, Michigan, 48326
Aclaris Clinical Site
Beverly Hills, California, 90212
Aclaris Study Site
Boise, Idaho, 83706
Aclaris Study Site
Bowling Green, Kentucky, 42104
Aclaris Study Site
Bryant, Arkansas, 71913
Aclaris Study Site
Camp Hill, Pennsylvania, 17011
Aclaris Clinical Site
Cary, North Carolina, 27518
Aclaris Study Site
Clarksville, Indiana, 47129
Aclaris Study Site
Coral Gables, Florida, 33134
Aclaris Clinical Site
Dallas, Texas, 75230
Aclaris Study Site
Encinitas, California, 92024
Aclaris Clinical Site
Encino, California, 91436
Aclaris Clinical Site
Hollywood, Florida, 33486
Aclaris Clinical Site
Houston, Texas, 77004
Aclaris Clinical Site
Huntington Beach, California, 92647
Aclaris Study Site
Indianapolis, Indiana, 46250
Aclaris Clinical Site
Jacksonville, Florida, 32256
Aclaris Clinical Site
Lafayette, Indiana, 47906
Aclaris Study Site
Los Angeles, California, 90045
Aclaris Clinical Site
Margate, Florida, 33063
Aclaris Clinical Site
Missoula, Montana, 59804
Aclaris Clinical Site
Myrtle Beach, South Carolina, 29588
Aclaris Study Site
New York, New York, 10023
Aclaris Study Site
New York, New York, 10075
Aclaris Clinical Site
New York, New York, 10128
Aclaris Study Site
Norfolk, Virginia, 23502
Aclaris Study Site
North Miami Beach, Florida, 33162
Aclaris Study Site
Oceanside, California, 92056
Aclaris Clinical Site
Philadelphia, Pennsylvania, 19103
Aclaris Clinical Site
Phoenix, Arizona, 85008
Aclaris Clinical Site
Providence, Utah, 84332
Aclaris Clinical Site
Ridgeland, Mississippi, 39157
Aclaris Study Site
Saint Joseph, Missouri, 64506
Aclaris Study Site
San Antonio, Texas, 78213
Aclaris Study Site
San Antonio, Texas, 78218
Aclaris Study Site
Santa Monica, California, 90404
Aclaris Clinical Site
Savannah, Georgia, 31405
Aclaris Clinical Site
Seattle, Washington, 98004
Aclaris Clinical Site
Sherman Oaks, California, 91403
Aclaris Clinical Site
Spokane, Washington, 99202
Aclaris Study Site
Sweetwater, Florida, 33172
Aclaris Study Site
Tampa, Florida, 33607
Aclaris Clinical Site
The Bronx, New York, 10455
Aclaris Clinical Site
The Woodlands, Texas, 77380
Aclaris Clinical Site
Thousand Oaks, California, 91320
Aclaris Clinical Site
Troy, Michigan, 48084
Aclaris Clinical Site
Tucson, Arizona, 85704
Aclaris Study Site
Webster, Texas, 77598
Aclaris Clinical Site
Wellington, Florida, 33449
Aclaris Study Site
West Lafayette, Indiana, 47906
Aclaris Clinical Site
Wilmington, North Carolina, 28405
Canada7 sites
Aclaris Clinical Site
Barrie, Ontario, L4M 7G1
Aclaris Site
Markham, Ontario, L3P 1X3
Aclaris Site
Mississauga, Ontario, L4Y 4C5
Aclaris Clinical Site
Montreal, Quebec, H1Y3L1
Aclaris Site
Richmond Hill, Ontario, L4B 1A5
Aclaris Clinical Site
Toronto, Ontario, M2N 3A6
Aclaris Site
Toronto, Ontario, M4W 2N2
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients With Moderate-to-Severe Atopic Dermatitis
This study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe Atopic Dermatitis.
Read the detailed description
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients with Moderate-to-Severe Atopic Dermatitis.
- Conditions
- Atopic Dermatitis, Atopic, Dermatitis, AD, Eczema
- Being tested
- ATI-045, Placebo
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-045Drug
ATI-045 group
PlaceboDrug
Placebo group
| Study group | Role | What they receive |
|---|---|---|
| ATI-045 group | Experimental | ATI-045 group Receives: Drug: ATI-045 |
| Placebo group | Placebo comparator | Placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Eczema Area and Severity Index (EASI)
Percent change from baseline in EASI score at Week 24
Measured: Baseline to Week 24
Secondary outcomes (7)
Investigator Global Assessment (vIGA) treatment success (IGA-TS)
Proportion of patients with validated Investigator Global Assessment (vIGA) treatment success (IGA-TS)
Measured: Baseline to Week 24
EASI reduction
Proportion of patients with EASI reduction of 75% (EASI75), 50% (EASI50), 90% (EASI90)
Measured: Baseline to Week 24
Peak Pruritus Numerical Rating Scale (PP-NRS) score
Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
Measured: Baseline to Week 24
PP-NRS improvement
Proportion of patients with a 4-point improvement or greater from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS)
Measured: Baseline to Week 24
Body Surface Area (BSA)
Change from baseline in BSA
Measured: Baseline to Week 24
Incidence and severity of safety measurements
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after first study drug dose on W0D1 until patient's last visit.
Measured: From Baseline to Week 34
Anti-ATI-045 antidrug antibody (ADA)
ADA evaluation
Measured: From Baseline to Week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start30 May 2025
- Primary completion21 Sep 2026
- Study completion24 Nov 2026 (estimated)
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 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
- NCT07011706
- Sponsor's protocol ID
- ATI-045-AD-201
- Status last verified
- Sep 2026
- First submitted
- 27 May 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07011706
- Acronym / sponsor ID
- ATI-045-AD-201
- Conditions
- Atopic Dermatitis, Atopic, Dermatitis, AD, Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 10 Jun 2025 (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 study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe Atopic Dermatitis.
Detailed description
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients with Moderate-to-Severe Atopic Dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATI-045 group | Experimental | Drug: ATI-045ATI-045 group |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of chronic atopic dermatitis that has been present for ≥ 6 months before the screening visit and with no significant AD flares during the past 4 weeks before screening
- Have active moderate to severe AD at screening and baseline visits
- EASI score ≥ 16 and ≥10% BSA at the screening and baseline visits
- History of inadequate response to treatment for AD with topical medications; or determination that topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks)
- Patient applied a stable dose of non-medicated topical moisturizer (ideally once or twice daily) for ≥ 7 days prior to the baseline visit and agrees to continue use during study
Key exclusion criteria (14 listed)
- Treatment with any of the following:
- History of anaphylaxis following biologic therapy.
- History of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine.
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-045ATI-045 group | Drug | ATI-045 group |
| PlaceboPlacebo group | Drug | Placebo group |
Primary outcome
Percent Change in Eczema Area and Severity Index (EASI)
Time frame: Baseline to Week 24
Percent change from baseline in EASI score at Week 24
7 secondary outcomes
Investigator Global Assessment (vIGA) treatment success (IGA-TS)
Time frame: Baseline to Week 24
EASI reduction
Time frame: Baseline to Week 24
Peak Pruritus Numerical Rating Scale (PP-NRS) score
Time frame: Baseline to Week 24
PP-NRS improvement
Time frame: Baseline to Week 24
Body Surface Area (BSA)
Time frame: Baseline to Week 24
Incidence and severity of safety measurements
Time frame: From Baseline to Week 34
Anti-ATI-045 antidrug antibody (ADA)
Time frame: From Baseline to Week 34
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
60 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 ATI-045 in people with Atopic Dermatitis and Atopic, run by Aclaris Therapeutics, Inc. at 60 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 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?
This study is still under way. Results are not available in the source record yet.
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?
Percent Change in Eczema Area and Severity Index (EASI) (time frame: Baseline to Week 24). 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 Sep 2026.