Table of Contents
- Trial overview
- Who participated
- What was studied
- Trial phases and status
- Outcomes measured
- What the trial records show
Trial overview
Two clinical trials in the source data are studying Img-007 in adults with atopic dermatitis, which is also called eczema.[1][2] One study is a Phase 2 trial in people with moderate-to-severe disease, and the other is a Phase 1 study in adults with atopic dermatitis.[1][2]
Both studies are interventional, which means participants receive a study treatment so researchers can compare results.[1][2] The records show that the trials are focused on two main questions: how safe Img-007 is and how well it may improve skin disease.[1][2]
Who participated
The Phase 2 study included adult participants with moderate-to-severe atopic dermatitis.[1] The Phase 1 study also included adults with atopic dermatitis.[2]
The source data do not give more details about age ranges, sex, or other entry rules beyond the adult population and the skin condition being studied.[1][2] This means the main target group was adults living with eczema, especially those with more serious disease in the Phase 2 trial.[1]
What was studied
The Phase 2 trial studied different dose regimens of Img-007 compared with placebo, which is a look-alike treatment without the active ingredient.[1] Its brief summary says the goal was to see the effect on disease activity at the end of the placebo-controlled period.[1]
The Phase 1 trial focused on adverse events, which are unwanted medical problems that happen during a study.[2] Its main purpose was to evaluate treatment-emergent adverse events, meaning side effects or medical problems that appear after treatment begins.[2]
The interventions listed in the records show Img-007 given in different ways across the studies, including subcutaneous injection and intravenous use, along with placebo in the Phase 1 record.[1][2] The source data do not provide more detail about the study design beyond what is listed in the trial records.[1][2]
Trial phases and status
The Phase 2 study, NCT2024-520117-50-00, is listed as Authorised and planned for 220 participants.[1] This phase usually means researchers are looking more closely at whether the treatment works, while still watching safety.[1]
The Phase 1 study, NCT05984784, is listed as Completed and enrolled 55 participants.[2] Phase 1 studies are usually early studies that focus mainly on safety and how the treatment is tolerated.[2]
Outcomes measured
The main outcome in the Phase 2 study is the mean percent change from baseline in EASI at Week 20.[1] Baseline means the starting point before treatment, and EASI stands for Eczema Area and Severity Index, a score that measures how much skin is affected and how severe the eczema is.[1]
The main outcome in the Phase 1 study is the incidence of TEAEs.[2] Incidence means how often these events happened during the study, and TEAEs means treatment-emergent adverse events.[2]
Together, these outcomes show that the trials are trying to understand both safety and possible benefit in atopic dermatitis.[1][2] The Phase 2 trial is centered on skin improvement, while the Phase 1 trial is centered on safety monitoring.[1][2]
What the trial records show
The available records show a small early evidence base for Img-007 in eczema, with one completed Phase 1 study and one authorised Phase 2 study.[1][2] The studies are not about the general use of the substance; they are about testing it in adults with atopic dermatitis under clinical trial conditions.[1][2]
The Phase 2 trial is the larger study in the source data, with 220 planned participants, and it uses placebo comparison to measure change in eczema severity.[1] The Phase 1 study is smaller, with 55 participants, and focuses on safety findings collected during treatment.[2]
