RECRUITING

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Description

The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.

Study Overview

Study Details

Study overview

The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.

A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Lancaster

Antelope Valley Clinical Trials, Lancaster, California, United States, 93534

Rolling Meadows

Arlington Dermatology, Rolling Meadows, Illinois, United States, 60008

Portland

Oregon Dermatology and Research Center, Portland, Oregon, United States, 97210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 74 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inmagene LLC,

Study Record Dates

2027-10