Summary

Eligibility
for people ages 18-74 (full criteria)
Location
at Lancaster, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

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

Details

A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 52 weeks.

Keywords

Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema, IMG-007, Dermatitis, Atopic, Dermatitis, Skin Diseases, Immune System Diseases, Dermatologic Agents

Eligibility

You can join if…

Open to people ages 18-74

  • 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

You CAN'T join if...

  • 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

Locations

  • Antelope Valley Clinical Trials accepting new patients
    Lancaster California 93534 United States
  • Oregon Dermatology and Research Center accepting new patients
    Portland Oregon 97210 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Inmagene LLC
Links
Sign up for this study
ID
NCT07037901
Phase
Phase 2 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated