Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis

Aclaris Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: ATI-1777 1.0% w/w; Drug: Vehicle; Drug: ATI-1777 0.5% w/w; Drug: ATI-1777 2.0% w/w

Study type: Interventional

Funder types: Industry

Identifiers

NCT05432596

ATI-1777-AD-202

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 6 patient groups, including a placebo group

ATI-1777 topical solution 2.0% w/w (BID)

Experimental group

Description:

ATI-1777 topical solution 2.0% w/w, twice daily

Treatment:

Drug: ATI-1777 2.0% w/w

ATI-1777 topical solution 1.0% w/w (BID)

Experimental group

Description:

ATI-1777 topical solution 1.0% w/w, twice daily

Treatment:

Drug: ATI-1777 1.0% w/w

ATI-1777 topical solution 0.5% w/w (BID)

Experimental group

Description:

ATI-1777 topical solution 0.5% w/w, twice daily

Treatment:

Drug: ATI-1777 0.5% w/w

Vehicle (BID)

Placebo Comparator group

Description:

Vehicle topical solution, twice daily

Treatment:

Drug: Vehicle

ATI-1777 topical solution 2.0% w/w (QD)

Experimental group

Description:

ATI-1777 topical solution 2.0% w/w, once daily

Treatment:

Drug: ATI-1777 2.0% w/w

Vehicle (QD)

Placebo Comparator group

Description:

Vehicle topical solution, once daily

Treatment:

Drug: Vehicle