Long-term Safety and Efficacy Evaluation of IMG-007 in Participants With Moderate-to-Severe Atopic Dermatitis

A Long-term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous IMG-007 in Participants of a Previous IMG-007 Moderate-To-Severe Atopic Dermatitis Clinical Trial

Status

Enrolling by invitation

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07734415

Enrollment

400

Registered

2026-07-29

Start date

2026-06-05

Completion date

2028-03-01

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema

Keywords

IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents

Brief summary

The purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD)

Interventions

DRUGIMG-007

Participants will receive IMG-007 subcutaneously.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Enrolling by invitation participants with moderate to severe AD who have completed IMG-007-203

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis	Baseline, Week 44	Incidence and severity of TEAEs, including treatment-emergent SAEs, AESIs, and AEs leading to discontinuation

Secondary

Measure	Time frame
Characterize the safety of long-term treatment with IMG-007 based on body temperature (Celsius)	Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on pulse rate (beats per minute)	Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on respiratory rate (breaths per minute)	Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on blood pressure (systolic and diastolic) (mmHg)	Baseline, Week 44
Number of Participants With Clinically Significant Abnormal (defined by rate, rhythm, morphology, and conduction abnormalities) ECG Findings (unit is number of participants).	Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by hematology	Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by blood chemistry	Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by urinalysis	Baseline, Week 44
Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Eczema Area and Severity Index (EASI)	Baseline, Week 44
Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)	Baseline, Week 44

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026