--- title: Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis nct_id: NCT05432596 overall_status: COMPLETED phase: PHASE2 sponsor: Aclaris Therapeutics, Inc. study_type: INTERVENTIONAL primary_condition: Atopic Dermatitis countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05432596.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05432596" ct_last_update_post_date: 2024-10-26 last_seen_at: "2026-05-12T06:14:00.642Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis **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) **NCT ID:** [NCT05432596](https://clinicaltrials.gov/study/NCT05432596) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 250 - **Lead Sponsor:** Aclaris Therapeutics, Inc. - **Conditions:** Atopic Dermatitis - **Start Date:** 2022-05-11 - **Completion Date:** 2023-11-14 - **CT.gov Last Update:** 2024-10-26 ## Brief 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. ## Eligibility - **Minimum age:** 12 Years - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures. 2. Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent. 3. 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. Exclusion Criteria: 1. Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period. 2. 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. 3. Female patients who are pregnant, nursing, or planning to become pregnant during the study. ``` ## Arms - **ATI-1777 topical solution 2.0% w/w (BID)** (EXPERIMENTAL) — ATI-1777 topical solution 2.0% w/w, twice daily - **ATI-1777 topical solution 1.0% w/w (BID)** (EXPERIMENTAL) — ATI-1777 topical solution 1.0% w/w, twice daily - **ATI-1777 topical solution 0.5% w/w (BID)** (EXPERIMENTAL) — ATI-1777 topical solution 0.5% w/w, twice daily - **Vehicle (BID)** (PLACEBO_COMPARATOR) — Vehicle topical solution, twice daily - **ATI-1777 topical solution 2.0% w/w (QD)** (EXPERIMENTAL) — ATI-1777 topical solution 2.0% w/w, once daily - **Vehicle (QD)** (PLACEBO_COMPARATOR) — Vehicle topical solution, once daily ## Interventions - **ATI-1777 2.0% w/w** (DRUG) — ATI-1777 topical solution 2.0% w/w - **ATI-1777 1.0% w/w** (DRUG) — ATI-1777 topical solution 1.0% w/w - **ATI-1777 0.5% w/w** (DRUG) — ATI-1777 topical solution 0.5% w/w - **Vehicle** (DRUG) — Vehicle topical solution ## Primary Outcomes - **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. ## 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)_ ## Locations (32) - Aclaris Investigational Site, Birmingham, Alabama, United States - Aclaris Investigational Site, Scottsdale, Arizona, United States - Aclaris Investigational Site, Bryant, Arkansas, United States - Aclaris Investigational Site, North Little Rock, Arkansas, United States - Aclaris Investigational Site, Encinitas, California, United States - Aclaris Investigational Site, Encino, California, United States - Aclaris Investigational Site, Castle Rock, Colorado, United States - Aclaris Investigational Site, Colorado Springs, Colorado, United States - Aclaris Investigational Site, Delray Beach, Florida, United States - Aclaris Investigational Site, Miami, Florida, United States - Aclaris Investigational Site, Miami Lakes, Florida, United States - Aclaris Investigational Site, Tampa, Florida, United States - Aclaris Investigational Site, West Palm Beach, Florida, United States - Aclaris Investigational Site, Sandy Springs, Georgia, United States - Aclaris Investigational Site, Normal, Illinois, United States - Aclaris Investigational Site, Skokie, Illinois, United States - Aclaris Investigational Site, Indianapolis, Indiana, United States - Aclaris Investigational Site, New Albany, Indiana, United States - Aclaris Investigational Site, West Lafayette, Indiana, United States - Aclaris Investigational Site, Baton Rouge, Louisiana, United States - Aclaris Investigational Site, Houma, Louisiana, United States - Aclaris Investigational Site, Saint Joseph, Missouri, United States - Aclaris Investigational Site, Wilmington, North Carolina, United States - Aclaris Investigational Site, Oklahoma City, Oklahoma, United States - Aclaris Investigational Site, Medford, Oregon, United States - Aclaris Investigational Site, Greenville, South Carolina, United States - Aclaris Investigational Site, Murfreesboro, Tennessee, United States - Aclaris Investigational Site, Arlington, Texas, United States - Aclaris Investigational Site, Dallas, Texas, United States - Aclaris Investigational Site, Houston, Texas, United States - Aclaris Investigational Site, San Antonio, Texas, United States - Aclaris Investigational Site, Richmond, Virginia, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.aclaris investigational site|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|scottsdale|arizona|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|bryant|arkansas|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|north little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|encinitas|california|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|encino|california|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|castle rock|colorado|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|colorado springs|colorado|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|delray beach|florida|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|miami|florida|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|miami lakes|florida|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|tampa|florida|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|west palm beach|florida|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|sandy springs|georgia|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|normal|illinois|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|skokie|illinois|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|new albany|indiana|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|west lafayette|indiana|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|baton rouge|louisiana|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|houma|louisiana|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|saint joseph|missouri|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|wilmington|north carolina|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|medford|oregon|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|greenville|south carolina|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|murfreesboro|tennessee|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|arlington|texas|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|dallas|texas|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|houston|texas|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.aclaris investigational site|richmond|virginia|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05432596.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05432596* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*