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

Inmagene

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema; Eczema

Treatments: Drug: Placebo; Drug: IMG-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT07037901

IMG-007-203

Details and patient eligibility

About

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

Full 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 52 weeks.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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220 participants in 4 patient groups, including a placebo group

IMG-007 dose 1

Experimental group

Description:

Subcutaneous injection as per protocol.

Treatment:

Drug: IMG-007

IMG-007 dose 2

Experimental group

Description:

Subcutaneous injection as per protocol.

Treatment:

Drug: IMG-007

IMG-007 dose 3

Experimental group

Description:

Subcutaneous injection as per protocol.

Treatment:

Drug: IMG-007

Placebo Crossover

Placebo Comparator group

Description:

Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.

Treatment:

Drug: IMG-007

Drug: Placebo