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Recruiting NCT07037901

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

Phase II Interventional Atopic Dermatitis Atopic Dermatitis Eczema Eczema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMG-007, Placebo.
Who it may be relevant to
Registry conditions: Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Detailed description

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 48 weeks.

Interventions

  • Drug IMG-007
    Participants will receive IMG-007 subcutaneously.
  • Drug Placebo
    Participants will receive a placebo subcutaneously.

Primary outcome measures

  • Mean percent change from baseline in EASI at Week 24 [Time frame: Baseline, Week 24]
Secondary outcome measures (4)
  • Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 24 [Time frame: Baseline, Week 24]
  • Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24 [Time frame: Baseline, Week 24]
  • Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24 [Time frame: Baseline, Week 24]
  • Incidence and severity of TEAE including treatment-emergent SAEs [Time frame: Baseline, End of Study]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 16 centers
  • Inmagene Site 1 — Lancaster
  • Inmagene Site 23 — Los Angeles
  • Inmagene Site 19 — Ocala
  • Inmagene Site 4 — Tampa
  • Inmagene Site 2 — Rolling Meadows
  • Inmagene Site 6 — Kew Gardens
  • Inmagene Site 21 — New York
  • Inmagene Site 11 — Woodbury
  • … and 8 more centers
Canada · 7 centers
  • Inmagene Site 15 — Surrey
  • Inmagene Site 22 — Vancouver
  • Inmagene Site 17 — Greater Sudbury
  • Inmagene Site 13 — Mississauga
  • Inmagene Site 18 — North Bay
  • Inmagene Site 14 — Montreal
  • Inmagene Site 16 — Saskatoon

Identifiers

NCT: NCT07037901 · IMG-007-203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗