Clinical trial NCT05984784: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Moderate-to-severe Atopic Dermatitis
AD
Keywords: IMG-007
Atopic Dermatitis
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Immune System Diseases
Dermatologic Agents
Lead sponsor: Inmagene LLC
Sponsor class: INDUSTRY
First posted: 2023-08-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluation of Adverse Events in Participants
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Pharmacokinetic Characterization
timeFrame: Baseline, Week 24
measure: Pharmacokinetic Characterization
timeFrame: Baseline, Week 24
measure: Evaluation of Eczema Area and Severity Index (EASI)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Amicis Research Center
state: California
city: Valencia
country: United States
facility: Amicis Research Center
state: California
city: Miami
country: United States
facility: Medical Research Center of Miami II Inc
state: Florida
city: Orange City
country: United States
facility: Optimal Research Sites
state: Florida
city: Tampa
country: United States
facility: USF Carol and Frank Morsani Center for Advanced Healthcare
state: Florida
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: New York
country: United States
facility: Markowitz Medical, LLC
state: New York
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc
state: Pennsylvania
city: Fredericton
country: Canada
facility: Brunswick Dermatology Center
state: New Brunswick
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Québec
country: Canada
facility: Centre de Recherche Saint-Louis (Québec)
Study officials:
References: