AD, Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
Conditions
Keywords
IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents
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 AD patients.
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 screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.
Interventions
DRUGPlacebo
Drug: Placebo Intravenous Infusion
DRUGIMG-007
Drug: IMG-007 Intravenous Infusion
Sponsors
Inmagene LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Adverse Events in Participants | Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks. | To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Characterization | Serum concentrations of IMG-007 were measured at Week 4 (pre-dose and post-dose), Week 12 (post-dose), and Week 24 (post-dose). | To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in AD participants |
| Evaluation of Eczema Area and Severity Index (EASI) | Mean percent change from baseline in Eczema Area and Severity Index (EASI) at week 12. | The Eczema Area and Severity Index (EASI) is a validated composite scoring system assessed by the investigator based on the body area involved in each of the four body regions (head and neck, upper limbs, lower limbs, and trunk) and the average severity of each of the four key signs of AD (erythema, edema/papulation, excoriation, and lichenification) based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The total EASI score ranges from 0 (clear or no eczema) to 72 (maximum severity), with higher values indicating more severe and/or extensive disease. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 IMG-007 Dose 1 IMG-007 Dose 1 was to be administered intravenously 3 times over 4 weeks
IMG-007: Drug: IMG-007 Intravenous Infusion | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Cohort 1 IMG-007 Dose 1 |
|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 15 |
| EASI score | 29.5 units on a scale STANDARD_DEVIATION 13.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 9 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Evaluation of Adverse Events in Participants
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)
Time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 IMG-007 Dose 1 | Evaluation of Adverse Events in Participants | Participants with at least 1 TEAE | 9 participants |
| Cohort 1 IMG-007 Dose 1 | Evaluation of Adverse Events in Participants | SAE | 0 participants |
| Cohort 1 IMG-007 Dose 1 | Evaluation of Adverse Events in Participants | Investigational product-related TEAE | 0 participants |
| Cohort 1 IMG-007 Dose 1 | Evaluation of Adverse Events in Participants | TEAE that was an infusion-related reaction | 0 participants |
| Cohort 1 IMG-007 Dose 1 | Evaluation of Adverse Events in Participants | TEAE leading to 4-week dosing period discontinuation | 0 participants |
| Cohort 1 IMG-007 Dose 1 | Evaluation of Adverse Events in Participants | TEAE with outcome of death | 0 participants |
Secondary
Evaluation of Eczema Area and Severity Index (EASI)
The Eczema Area and Severity Index (EASI) is a validated composite scoring system assessed by the investigator based on the body area involved in each of the four body regions (head and neck, upper limbs, lower limbs, and trunk) and the average severity of each of the four key signs of AD (erythema, edema/papulation, excoriation, and lichenification) based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The total EASI score ranges from 0 (clear or no eczema) to 72 (maximum severity), with higher values indicating more severe and/or extensive disease.
Time frame: Mean percent change from baseline in Eczema Area and Severity Index (EASI) at week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 IMG-007 Dose 1 | Evaluation of Eczema Area and Severity Index (EASI) | -68.5 percentage of change | Standard Error 11.4 |
Secondary
Pharmacokinetic Characterization
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in AD participants
Time frame: Serum concentrations of IMG-007 were measured at Week 4 (pre-dose and post-dose), Week 12 (post-dose), and Week 24 (post-dose).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 IMG-007 Dose 1 | Pharmacokinetic Characterization | Week 4, Pre-dose | 47650.0 ng/mL | Standard Deviation 16255.6 |
| Cohort 1 IMG-007 Dose 1 | Pharmacokinetic Characterization | Week 4, Post-dose | 131400.0 ng/mL | Standard Deviation 18379.3 |
| Cohort 1 IMG-007 Dose 1 | Pharmacokinetic Characterization | Week 12, Post-dose | 16088.0 ng/mL | Standard Deviation 12662.2 |
| Cohort 1 IMG-007 Dose 1 | Pharmacokinetic Characterization | Week 24, Post-Dose | 1334.2 ng/mL | Standard Deviation 1720.5 |