NCT05432596CompletedPhase 2
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
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)
Source: ClinicalTrials.gov · Last updated 26 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (actual)
- First submitted
- 1 Jun 2022
- Start date
- 11 May 2022
- Primary completion date
- 26 Oct 2023
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05432596
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 250
- From 11 May 2022 to the primary completion date, 26 Oct 2023
- 32 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
- Female patients who are pregnant, nursing, or planning to become pregnant during the study.
Who the study is looking for
- 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 12 to 65 years old, inclusive, at the time of informed consent/assent.
- 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.
Age in the registry: 12 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.