Trial Outcomes & Findings for Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis (NCT NCT04598269)

NCT ID: NCT04598269

Last Updated: 2023-09-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline, Week 4
• Results posted on: 2023-09-28

Participant Flow

Participant milestones

Measure	ATI-1777 ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle Vehicle topical solution, twice daily
Overall Study STARTED	25	25
Overall Study Received at Least 1 Dose of Study Drug	23	25
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Measure	ATI-1777 ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle Vehicle topical solution, twice daily
Overall Study Adverse Event	0	3
Overall Study Withdrawal by Subject	1	4
Overall Study Lost to Follow-up	1	0
Overall Study Not Treated	2	0

Baseline Characteristics

Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis

Baseline characteristics by cohort

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 Participants Vehicle topical solution, twice daily	Total n=48 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 13.99 • n=5 Participants	41.4 years STANDARD_DEVIATION 14.31 • n=7 Participants	42.3 years STANDARD_DEVIATION 14.03 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiple race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Full Analysis Set: included all participants who were randomized and administered at least one dose of study medication. Data was imputed using last observation carried forward (LOCF).

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.

Outcome measures

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 Participants Vehicle topical solution, twice daily
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4	-74.45 percent change Standard Error 6.455	-41.43 percent change Standard Error 6.189

SECONDARY outcome

Timeframe: Baseline, Days 8 and 15

Population: Full Analysis Set: included all participants who were randomized and administered at least one dose of study medication. Data was imputed using LOCF.

The EASI evaluation is performed by the Principal Investigator and will evaluate 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 range from 0-72, with higher scores indicative of more severe disease.

Outcome measures

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 Participants Vehicle topical solution, twice daily
Percent Change From Baseline in EASI Score at Days 8 and 15 Day 8	-35.95 percent change Standard Error 6.455	-12.42 percent change Standard Error 6.189
Percent Change From Baseline in EASI Score at Days 8 and 15 Day 15	-54.12 percent change Standard Error 6.455	-30.68 percent change Standard Error 6.189

SECONDARY outcome

Timeframe: Week 4

Population: Full Analysis Set: included all participants who were randomized and administered at least one dose of study medication.

The EASI evaluation is performed by the Principal Investigator and will evaluate 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 range from 0-72, with higher scores indicative of more severe disease.

Outcome measures

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 Participants Vehicle topical solution, twice daily
Number of Participants Who Achieve 50% Improvement in EASI Score (EASI 50) by Week 4	21 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Full Analysis Set: included all participants who were randomized and administered at least one dose of study medication.

The EASI evaluation is performed by the Principal Investigator and will evaluate 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 range from 0-72, with higher scores indicative of more severe disease.

Outcome measures

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 Participants Vehicle topical solution, twice daily
Number of Participants Who Achieve 75% Improvement in EASI Score (EASI-75) by Week 4	15 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Full Analysis Set: included all participants who were randomized and administered at least one dose of study medication.

The EASI evaluation is performed by the Principal Investigator and will evaluate 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 range from 0-72, with higher scores indicative of more severe disease.

Outcome measures

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 Participants Vehicle topical solution, twice daily
Number of Participants Who Achieve 90% Improvement in EASI Score (EASI-90) by Week 4	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, Days 8 and 15, and Week 4

Population: Full Analysis Set: included all participants who were randomized and administered at least one dose of study medication. Data was imputed using LOCF.

The IGA is a validated investigator's assessment of the average overall severity of participants' atopic dermatitis at a particular point in time. Scores ranged from 0-4, with higher scores indicative of more severe disease.

Outcome measures

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 Participants Vehicle topical solution, twice daily
Change From Baseline in Investigator Global Assessment (IGA) Score for Atopic Dermatitis at Days 8 and 15, and Week 4 Day 8	-0.50 units on a scale Standard Error 0.163	-0.26 units on a scale Standard Error 0.156
Change From Baseline in Investigator Global Assessment (IGA) Score for Atopic Dermatitis at Days 8 and 15, and Week 4 Day 15	-1.15 units on a scale Standard Error 0.163	-0.66 units on a scale Standard Error 0.156
Change From Baseline in Investigator Global Assessment (IGA) Score for Atopic Dermatitis at Days 8 and 15, and Week 4 Week 4	-1.59 units on a scale Standard Error 0.163	-0.90 units on a scale Standard Error 0.156

SECONDARY outcome

Timeframe: Baseline, Days 8 and 15, and Week 4

Population: Full Analysis Set: included all participants who were randomized and administered at least one dose of study medication. Data was imputed using LOCF.

The total percentage of the participants BSA affected by atopic dermatitis was estimated by the investigator or designee using the handprint method, which estimates that the area of a participants' full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores ranged from 0-100%, with higher scores indicative of increased percentage of atopic dermatitis on the skin.

Outcome measures

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 Participants Vehicle topical solution, twice daily
Change From Baseline in Percent of Body Surface Area (BSA) of Atopic Dermatitis at Days 8 and 15 and Week 4 Day 8	-1.55 percentage of BSA Standard Error 0.616	-0.37 percentage of BSA Standard Error 0.590
Change From Baseline in Percent of Body Surface Area (BSA) of Atopic Dermatitis at Days 8 and 15 and Week 4 Day 15	-3.33 percentage of BSA Standard Error 0.616	-1.57 percentage of BSA Standard Error 0.590
Change From Baseline in Percent of Body Surface Area (BSA) of Atopic Dermatitis at Days 8 and 15 and Week 4 Week 4	-5.59 percentage of BSA Standard Error 0.616	-2.09 percentage of BSA Standard Error 0.590

SECONDARY outcome

Timeframe: Baseline, Days 8 and 15, and Week 4

Population: Full Analysis Set: included all participants who were randomized and administered at least one dose of study medication. Data was imputed using LOCF. Here, Overall Number of Participants Analyzed represents the participants evaluable for this measure.

The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores ranged from 0-10, with higher scores indicative of more severe itching.

Outcome measures

Measure	ATI-1777 n=23 Participants ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=24 Participants Vehicle topical solution, twice daily
Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Days 8 and 15, and Week 4 Day 8	-2.18 units on a scale Standard Error 0.548	-0.45 units on a scale Standard Error 0.536
Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Days 8 and 15, and Week 4 Day 15	-2.57 units on a scale Standard Error 0.548	-1.41 units on a scale Standard Error 0.536
Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Days 8 and 15, and Week 4 Week 4	-2.92 units on a scale Standard Error 0.548	-1.70 units on a scale Standard Error 0.536

Adverse Events

ATI-1777

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ATI-1777 n=23 participants at risk ATI-1777 topical solution 2.0% w/w, twice daily	Vehicle n=25 participants at risk Vehicle topical solution, twice daily
Blood and lymphatic system disorders Blood creatine phosphokinase increased	8.7% 2/23 • Day 1 (after dosing) through Day 42	0.00% 0/25 • Day 1 (after dosing) through Day 42
Nervous system disorders Headache	8.7% 2/23 • Day 1 (after dosing) through Day 42	0.00% 0/25 • Day 1 (after dosing) through Day 42

Additional Information

Clinical Operations

Aclaris Therapeutics, Inc.

Phone: 1-833-225-2747

Email: clinicaloperations@aclaristx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place