NCT04090229

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: ASLAN Pharmaceuticals · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1B, multi-center, double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) clinical study is designed to evaluate ASLAN004 versus placebo in patients who have moderate-severe AD. The treatment period duration will be 8 weeks with a 12-week follow-up period after the end of treatment.

Detailed description

The study is designed as a MAD escalation in up to 3 cohorts of patients, followed by a cohort expansion to further confirm the safety and tolerability of the selected dose, prior to further investigation in Phase 2 studies. The cohort expansion will also support the assessment of the trial's secondary efficacy objectives. Approximately 50 patients are planned to be enrolled across the entire study. Approximately 24 patients are planned to be enrolled in the initial MAD escalation, with a maximum of 3 ascending dose levels (low, medium and high) of ASLAN004 (Cohorts 1-3). In all dose cohorts, 8 patients will be randomized in a 3:1 ratio to receive ASLAN004 (at specified cohort dose, n=6) or matching placebo (n=2). Additional cohorts may be optional depending on the data from the preceding cohort. An expansion cohort (Cohort 4) of approximately 27 patients is planned and will be randomized in a 2:1 ratio to receive ASLAN004 (n=18) or matching placebo (n=9). The rationale for this is to provide greater assurance about the safety and tolerability of the selected dose level, and to provide preliminary estimates of the PD and clinical effects at this dose, prior to further dose and schedule finding work in Phase 2 studies. A total of 8 subcutaneous injections of ASLAN004 or matching placebo will be administered according to a weekly schedule of injection from Day 1 (baseline visit) to Day 50 (Week 7) of the study. Patients will be closely monitored and observed for a period of 30 minutes after each injection of study drug (all visits). The clinical assessments and blood sampling for safety laboratory tests, PK analysis, ADA assays, and biomarkers will be performed at each visit as noted in the Schedule of Assessments. The treatment period will end at the last day of Week 8 (ie., Day 56) after which patients will be followed every week for 12 weeks for safety, PK parameters, ADA, and PD marker assessments. In the event that patients develop adverse events (AEs)/serious AEs (SAEs) which are determined as definitely related, probably related, or possibly related to ADA, and/or patients have a positive ADA result, additional unscheduled sampling of ADA may be performed during the study or after Day 141, as deemed clinically necessary. The exact timepoints for ADA sampling after Day 141 will be discussed between the Investigator and Sponsor for each case.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ASLAN004	Subcutaneous injections of ASLAN004 100 mg/mL will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.
DRUG	ASLAN004 Placebo	Subcutaneous injections of ASLAN004 Placebo will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.

Timeline

• Start date: 2019-09-09
• Primary completion: 2021-10-28
• Completion: 2021-12-03
• First posted: 2019-09-16
• Last updated: 2022-01-12

Locations

11 sites across 3 countries: United States, Australia, Singapore

Regulatory

• FDA-regulated drug study