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Trial record 1 of 1 for:    IMG-007 | Atopic Dermatitis
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A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05984784
Recruitment Status : Active, not recruiting
First Posted : August 9, 2023
Last Update Posted : March 20, 2024
Sponsor:
Information provided by (Responsible Party):
Inmagene LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Moderate-to-severe Atopic Dermatitis AD Drug: Placebo Drug: IMG-007 Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 9, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: IMG-007 Dose 1
IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
 Drug: IMG-007
Drug: IMG-007 Intravenous Infusion
Experimental: IMG-007 Dose 2
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
 Drug: IMG-007
Drug: IMG-007 Intravenous Infusion
Placebo Comparator: Placebo
Placebo will be administered intravenously 3 times over 4 weeks
 Drug: Placebo
Drug: Placebo Intravenous Infusion


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of Adverse Events in Participants [ Time Frame: Baseline, Week 24 ]
    To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)


Secondary Outcome Measures :
  1. Pharmacokinetic Characterization [ Time Frame: Baseline, Week 24 ]
    To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants

  2. Pharmacokinetic Characterization [ Time Frame: Baseline, Week 24 ]
    To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants

  3. Evaluation of Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 12 ]
    To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984784


Locations
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United States, California
Amicis Research Center
Northridge, California, United States, 91324
Amicis Research Center
Valencia, California, United States, 91355
United States, Florida
Medical Research Center of Miami II Inc
Miami, Florida, United States, 33134
Optimal Research Sites
Orange City, Florida, United States, 32763
USF Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States, 33612
United States, Michigan
Revival Research Institute, LLC
Troy, Michigan, United States, 48084
United States, New York
Markowitz Medical, LLC
New York, New York, United States, 10128
United States, Oklahoma
Central Sooner Research
Oklahoma City, Oklahoma, United States, 73170
United States, Pennsylvania
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, United States, 19103
Canada, New Brunswick
Brunswick Dermatology Center
Fredericton, New Brunswick, Canada, E3B 1G9
Canada, Ontario
DermEffects
London, Ontario, Canada, N6H 5L5
Canada
Centre de Recherche Saint-Louis (Québec)
Québec, Canada, G1W4R4
Sponsors and Collaborators
Inmagene LLC
More Information
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Responsible Party: Inmagene LLC
ClinicalTrials.gov Identifier: NCT05984784    
Other Study ID Numbers: IMG-007-201
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inmagene LLC:
IMG-007
Atopic Dermatitis
Dermatitis, Atopic
Dermatitis
 Eczema
Skin Diseases
Immune System Diseases
Dermatologic Agents
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases