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NCT04598269 · ClinicalTrials.gov registry record · Phase 2
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
A Phase 2 study of Atopic Dermatitis, sponsored by Aclaris Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 14
- Study locations
NCT04598269: Completed Phase 2 study of Atopic Dermatitis, sponsored by Aclaris Therapeutics.
NCT04598269 is a Phase 2 study of Atopic Dermatitis that has completed, run by Aclaris Therapeutics. The registered enrollment target is 50 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (92% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04598269, a Phase 2 study of Atopic Dermatitis, has completed, sponsored by Aclaris Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of participants with moderate or severe atopic dermatitis (AD).
Primary Outcome
The EASI evaluation was performed by the Principal Investigator and evaluated atopic dermatitis in each of 3 body regions (trunk \[excluding groin and genitalia\], upper extremities \[excluding palms of hands\], and lower extremities \[excluding soles of feet\]). The EASI scoring system uses a defined process to grade the severity of the signs of atopic dermatitis and the extent affected. EASI Scores ranged from 0-72, with higher scores indicative of more severe disease.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG ATI-1777
Study Locations (14)
California
- Aclaris Investigational Site - Encino
- Aclaris Investigational Site - Los Angeles
Texas
- Aclaris Investigational Site - Austin
- Aclaris Investigational Site - San Antonio
Virginia
- Aclaris Investigational Site - Lynchburg
- Aclaris Investigational Site - Newport News
Arizona
- Aclaris Investigational Site - Scottsdale
Florida
- Aclaris Investigational Site - Tampa
Indiana
- Aclaris Investigational Site - Indianapolis
Kansas
- Aclaris Investigational Site - Overland Park
Nebraska
- Aclaris Investigational Site - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2021-04-22 |
| Phase | Phase 2 |
What the finished NCT04598269 record still lists
NCT04598269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT04598269 lists 14 locations in 11 states (California, Texas, Virginia).
Frequently Asked Questions
What is clinical trial NCT04598269 about?
NCT04598269 is a clinical study titled "Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis". This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of participants with moderate or severe atopic dermatitis (AD).
What is the current status of trial NCT04598269?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2020-09-30. Estimated completion is 2021-04-22.
What conditions does trial NCT04598269 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT04598269?
The interventions under investigation include: Vehicle (DRUG), ATI-1777 (DRUG).
Who is sponsoring clinical trial NCT04598269?
This trial is sponsored by Aclaris Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04598269 being conducted?
This trial has 14 study locations across Arizona, California, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04598269's enrollment target sits among peer trials
50 109th of 150 higher than 42 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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