Atopic Dermatitis
Conditions
Keywords
Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases, Eczematous, Skin Diseases
Brief summary
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.
Interventions
DRUGATI-2138
ATI-2138 Oral Tablets BID
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment emergent adverse events (TEAEs) | From baseline up to two weeks after treatment (Day 98) |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline Eczema Area and Severity Index (EASI) Over Time | Up to Week 12 |
| Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time | Up to Week 12 |
| Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time | Up to Week 12 |
| Change in IGA score over time | Up to Week 12 |
| Change from baseline in AD Body Surface Area (BSA) over time | Up to week 12 |
| Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time | Up to Week 12 |
| ATI-2138 trough concentration ng/mL | Day 1 to Week 12 |
| ATI-2138 peak concentration (Cmax) ng/mL | Day 1 to Week 12 |
Countries
United States
Contacts
STUDY_DIRECTORAjay Aggarwal, MD
Aclaris Therapeutics, Inc.
Outcome results
None listed