Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema
Conditions
Keywords
IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents
Brief summary
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
Detailed description
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.
Interventions
DRUGIMG-007
Participants will receive IMG-007 subcutaneously.
DRUGPlacebo
Participants will receive a placebo subcutaneously.
Sponsors
Inmagene LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 * EASI score ≥16 * vIGA-AD score ≥3 * ≥10% body surface area (BSA) of AD involvement * Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization Key
Exclusion criteria
* 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 * 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 * Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline in EASI at Week 24 | Baseline, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 24 | Baseline, Week 24 |
| Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24 | Baseline, Week 24 |
| Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24 | Baseline, Week 24 |
| Incidence and severity of TEAE including treatment-emergent SAEs | Baseline, End of Study |
Countries
Australia, Canada, New Zealand, United States
Contacts
CONTACTADAPTIVE Study Lead
Outcome results
None listed