The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.
This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Amicis Research Center
Northridge, California, United States
Amicis Research Center
Valencia, California, United States
Medical Research Center of Miami II Inc
Miami, Florida, United States
Evaluation of Adverse Events in Participants
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)
Time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
Pharmacokinetic Characterization
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in AD participants
Time frame: Serum concentrations of IMG-007 were measured at Week 4 (pre-dose and post-dose), Week 12 (post-dose), and Week 24 (post-dose).
Evaluation of Eczema Area and Severity Index (EASI)
The Eczema Area and Severity Index (EASI) is a validated composite scoring system assessed by the investigator based on the body area involved in each of the four body regions (head and neck, upper limbs, lower limbs, and trunk) and the average severity of each of the four key signs of AD (erythema, edema/papulation, excoriation, and lichenification) based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The total EASI score ranges from 0 (clear or no eczema) to 72 (maximum severity), with higher values indicating more severe and/or extensive disease.
Time frame: Mean percent change from baseline in Eczema Area and Severity Index (EASI) at week 12.
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Optimal Research Sites
Orange City, Florida, United States
USF Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Markowitz Medical, LLC
New York, New York, United States
Central Sooner Research
Oklahoma City, Oklahoma, United States
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, United States
Brunswick Dermatology Center
Fredericton, New Brunswick, Canada
...and 2 more locations