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A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

Primary Purpose

Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis, AD

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
IMG-007
Sponsored by
Inmagene LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

IMG-007 Dose 1

IMG-007 Dose 2

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Pharmacokinetic Characterization
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants
Pharmacokinetic Characterization
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants
Evaluation of Eczema Area and Severity Index (EASI)
To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)

Full Information

First Posted
July 25, 2023
Last Updated
September 1, 2023
Sponsor
Inmagene LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05984784
Brief Title
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)
Official Title
A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmagene LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis, AD
Keywords
IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMG-007 Dose 1
Arm Type
Experimental
Arm Description
IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
Arm Title
IMG-007 Dose 2
Arm Type
Experimental
Arm Description
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered intravenously 3 times over 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drug: Placebo Intravenous Infusion
Intervention Type
Drug
Intervention Name(s)
IMG-007
Intervention Description
Drug: IMG-007 Intravenous Infusion
Primary Outcome Measure Information:
Title
Evaluation of Adverse Events in Participants
Description
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Pharmacokinetic Characterization
Description
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants
Time Frame
Baseline, Week 24
Title
Pharmacokinetic Characterization
Description
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants
Time Frame
Baseline, Week 24
Title
Evaluation of Eczema Area and Severity Index (EASI)
Description
To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carina Freedman, M.S.
Phone
858-346-6927
Email
freedmanc@inmagenebio.com
Facility Information:
Facility Name
Medical Research Center of Miami II Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Revival Research Institute, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Markowitz Medical, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Sooner Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73170
Country
United States
Individual Site Status
Recruiting
Facility Name
Paddington Testing Co, Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

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