In short
Clinical trials are studying Img-007 in adults with atopic dermatitis, also called eczema. These studies are looking at safety, side effects, and how well Img-007 works compared with placebo. The trials include people with moderate-to-severe disease and use different phases to test the treatment in a step-by-step way.
Key points
- Clinical trials of Img-007 are studying adults with atopic dermatitis, including people with moderate-to-severe disease. The trial data include one Phase 1 study and one Phase 2 study. The Phase 1 study focused on safety and treatment-emergent adverse events, while the Phase 2 study looked at how well Img-007 works compared with placebo. One key outcome is the change in EASI, a score that measures eczema severity and affected skin area. The studies together show a step-by-step approach to testing Img-007 in this skin condition.
Trial overview
Two clinical trials in the source data are studying Img-007 in adults with atopic dermatitis, which is also called eczema. 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.
Both studies are interventional, which means participants receive a study treatment so researchers can compare results. 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.
Who participated
The Phase 2 study included adult participants with moderate-to-severe atopic dermatitis. The Phase 1 study also included adults with atopic dermatitis.
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. This means the main target group was adults living with eczema, especially those with more serious disease in the Phase 2 trial.
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. Its brief summary says the goal was to see the effect on disease activity at the end of the placebo-controlled period.
The Phase 1 trial focused on adverse events, which are unwanted medical problems that happen during a study. Its main purpose was to evaluate treatment-emergent adverse events, meaning side effects or medical problems that appear after treatment begins.
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. The source data do not provide more detail about the study design beyond what is listed in the trial records.
Trial phases and status
The Phase 2 study, NCT2024-520117-50-00, is listed as Authorised and planned for 220 participants. This phase usually means researchers are looking more closely at whether the treatment works, while still watching safety.
The Phase 1 study, NCT05984784, is listed as Completed and enrolled 55 participants. Phase 1 studies are usually early studies that focus mainly on safety and how the treatment is tolerated.
Outcomes measured
The main outcome in the Phase 2 study is the mean percent change from baseline in EASI at Week 20. 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.
The main outcome in the Phase 1 study is the incidence of TEAEs. Incidence means how often these events happened during the study, and TEAEs means treatment-emergent adverse events.
Together, these outcomes show that the trials are trying to understand both safety and possible benefit in atopic dermatitis. The Phase 2 trial is centered on skin improvement, while the Phase 1 trial is centered on safety monitoring.
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. 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.
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. The Phase 1 study is smaller, with 55 participants, and focuses on safety findings collected during treatment.