A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)
Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis, AD
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents
Eligibility Criteria
Key Inclusion Criteria: Male or female aged ≥ 18 and < 75 years. Moderate-to-severe AD. Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable. Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception. Key Exclusion Criteria: Known hepatitis B, hepatitis C, or human immunodeficiency virus infection. Evidence of active or latent tuberculosis (TB). History of untreated or inadequately treated TB infection. Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit. Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement. Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
Sites / Locations
- Medical Research Center of Miami II IncRecruiting
- Revival Research Institute, LLCRecruiting
- Markowitz Medical, LLCRecruiting
- Central Sooner ResearchRecruiting
- Paddington Testing Co, IncRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
IMG-007 Dose 1
IMG-007 Dose 2
Placebo
IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
Placebo will be administered intravenously 3 times over 4 weeks