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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Participants will receive IMG-007 subcutaneously.
Inmagene Site 1
Lancaster, California, United States
Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis
Incidence and severity of TEAEs, including treatment-emergent SAEs, AESIs, and AEs leading to discontinuation
Time frame: Baseline, Week 44
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Inmagene Site 23
Los Angeles, California, United States
Inmagene Site 19
Ocala, Florida, United States
Inmagene Site 4
Tampa, Florida, United States
Inmagene Site 2
Rolling Meadows, Illinois, United States
Inmagene Site 6
Kew Gardens, New York, United States
Inmagene Site 21
New York, New York, United States
Inmagene Site 11
Woodbury, New York, United States
Inmagene Site 20
Charlotte, North Carolina, United States
Inmagene Site 10
Fargo, North Dakota, United States
...and 13 more locations
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