Long-term Safety and Efficacy Evaluation of IMG-007 in Participants With Moderate-to-Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMG-007.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug IMG-007
Participants will receive IMG-007 subcutaneously.
Primary outcome measures
- Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis [Time frame: Baseline, Week 44]
Secondary outcome measures (10)
- Characterize the safety of long-term treatment with IMG-007 based on body temperature (Celsius) [Time frame: Baseline, Week 44]
- Characterize the safety of long-term treatment with IMG-007 based on pulse rate (beats per minute) [Time frame: Baseline, Week 44]
- Characterize the safety of long-term treatment with IMG-007 based on respiratory rate (breaths per minute) [Time frame: Baseline, Week 44]
- Characterize the safety of long-term treatment with IMG-007 based on blood pressure (systolic and diastolic) (mmHg) [Time frame: 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). [Time frame: Baseline, Week 44]
- Characterize the safety of long-term treatment with IMG-007, as assessed by hematology [Time frame: Baseline, Week 44]
- Characterize the safety of long-term treatment with IMG-007, as assessed by blood chemistry [Time frame: Baseline, Week 44]
- Characterize the safety of long-term treatment with IMG-007, as assessed by urinalysis [Time frame: 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) [Time frame: 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) [Time frame: Baseline, Week 44]
Eligibility criteria
Enrolling by invitation participants with moderate to severe AD who have completed IMG-007-203
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- Inmagene Site 1 — Lancaster
- Inmagene Site 23 — Los Angeles
- Inmagene Site 19 — Ocala
- Inmagene Site 4 — Tampa
- Inmagene Site 2 — Rolling Meadows
- Inmagene Site 6 — Kew Gardens
- Inmagene Site 21 — New York
- Inmagene Site 11 — Woodbury
- … and 8 more centers
Canada · 7 centers
- Inmagene Site 15 — Surrey
- Inmagene Site 22 — Vancouver
- Inmagene Site 17 — Greater Sudbury
- Inmagene Site 13 — Mississauga
- Inmagene Site 18 — North Bay
- Inmagene Site 14 — Montreal
- Inmagene Site 16 — Saskatoon
Identifiers
NCT: NCT07734415 · IMG-007-205