Status:
TERMINATED
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)
Lead Sponsor:
Inmagene LLC
Conditions:
Atopic Dermatitis
Moderate-to-severe Atopic Dermatitis
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in ...
Detailed Description
This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a s...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05984784
Start Date
August 9 2023
End Date
April 26 2024
Last Update
November 6 2025
Active Locations (12)
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1
Amicis Research Center
Northridge, California, United States, 91324
2
Amicis Research Center
Valencia, California, United States, 91355
3
Medical Research Center of Miami II Inc
Miami, Florida, United States, 33134
4
Optimal Research Sites
Orange City, Florida, United States, 32763