A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorInmagene LLC
About this trial
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
Eligibility criteria
Qualifiers
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
Male participants must agree to use a highly effective method of contraception
Disqualifiers
Positive 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
Trial design
Treatments tested in this trial
- IMG-007
- Placebo
Treatment groups
405 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Locations
23Canada
Inmagene Site 15V3R 6A7, SurreyBritish Columbia, Canada
Inmagene Site 22V6H 4B1, VancouverBritish Columbia, Canada
Inmagene Site 17P3C 1X8, Greater SudburyOntario, Canada
Inmagene Site 13L4Y 4C5, MississaugaOntario, Canada
Sponsors and collaborators
Inmagene LLC
Lead sponsor
Source ClinicalTrials.gov