Atopic DermatitisPhase 2NCT06585202
Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing ATI-2138 in people with Atopic Dermatitis, run by Aclaris Therapeutics, Inc. at 6 sites in United States.
Trial summary
This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ATI-2138
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Aug 2024to 31 Mar 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- 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 18 to 60 years old, inclusive, at the time of informed consent/assent.
- Have at least a 1-year history of moderate or severe AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit as determined by the Investigator upon review of participant medical history.
Who cannot join
- Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any time prior to Screening.
- Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
- Refractory AD (ie, AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit).
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Aclaris Investigational Site
Austin, Texas, 78759
Aclaris Investigational Site
Birmingham, Alabama, 35244
Aclaris Investigational Site
Encino, California, 91436
Aclaris Investigational Site
Plainfield, Indiana, 46168
Aclaris Investigational Site
San Antonio, Texas, 78213
Aclaris Investigational Site
San Diego, California, 92123
About this study
Official title: A Phase 2a Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of ATI-2138 Administered Over 12 Weeks in Participants With Moderate to Severe Atopic Dermatitis
This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.
Read the detailed description
This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- ATI-2138
- Keywords
- Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases, Eczematous, Skin Diseases
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis, Skin Diseases, Eczematous, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-2138Drug
ATI-2138 Oral Tablets BID
| Study group | Role | What they receive |
|---|---|---|
| ATI-2138 | Experimental | ATI-2138 oral tablets BID Receives: Drug: ATI-2138 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse events (TEAEs)
Measured: From baseline up to two weeks after treatment (Day 98)
Secondary outcomes (8)
Change from baseline Eczema Area and Severity Index (EASI) Over Time
Measured: Up to Week 12
Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time
Measured: Up to Week 12
Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time
Measured: Up to Week 12
Change in IGA score over time
Measured: Up to Week 12
Change from baseline in AD Body Surface Area (BSA) over time
Measured: Up to week 12
Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time
Measured: Up to Week 12
ATI-2138 trough concentration ng/mL
Measured: Day 1 to Week 12
ATI-2138 peak concentration (Cmax) ng/mL
Measured: Day 1 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start19 Aug 2024
- Primary completion13 Mar 2025
- Study completion31 Mar 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ajay Aggarwal, MD, Study director, Aclaris Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585202
- Sponsor's protocol ID
- ATI-2138-AD-201
- Status last verified
- Feb 2026
- First submitted
- 3 Sep 2024
- Last updated
- 12 Mar 2026
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of ATI-2138 Administered Over 12 Weeks in Participants With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06585202
- Acronym / sponsor ID
- ATI-2138-AD-201
- Conditions
- Atopic Dermatitis
- Keywords
- Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases, Eczematous, Skin Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 5 Sep 2024 (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 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.
Detailed description
This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATI-2138 | Experimental | Drug: ATI-2138ATI-2138 oral tablets BID |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 18 to 60 years old, inclusive, at the time of informed consent/assent.
- Have at least a 1-year history of moderate or severe AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit as determined by the Investigator upon review of participant medical history.
Key exclusion criteria (5 listed)
- Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any time prior to Screening.
- Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
- Refractory AD (ie, AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit).
- 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-2138ATI-2138 Oral Tablets BID | Drug | ATI-2138 |
Primary outcome
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: From baseline up to two weeks after treatment (Day 98)
8 secondary outcomes
Change from baseline Eczema Area and Severity Index (EASI) Over Time
Time frame: Up to Week 12
Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time
Time frame: Up to Week 12
Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time
Time frame: Up to Week 12
Change in IGA score over time
Time frame: Up to Week 12
Change from baseline in AD Body Surface Area (BSA) over time
Time frame: Up to week 12
Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time
Time frame: Up to Week 12
ATI-2138 trough concentration ng/mL
Time frame: Day 1 to Week 12
ATI-2138 peak concentration (Cmax) ng/mL
Time frame: Day 1 to Week 12
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 12 Mar 2026.
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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.
Ajay Aggarwal, MD study director
Aclaris Therapeutics, Inc.
6 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-2138 in people with Atopic Dermatitis, run by Aclaris Therapeutics, Inc. at 6 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 5 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
Incidence and severity of treatment emergent adverse events (TEAEs) (time frame: From baseline up to two weeks after treatment (Day 98)). 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 12 Mar 2026.