A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

Inmagene

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Atopic Dermatitis; AD; Moderate-to-severe Atopic Dermatitis

Treatments: Drug: IMG-007; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05984784

IMG-007-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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13 participants in 3 patient groups, including a placebo group

Cohort 1 IMG-007 Dose 1

Experimental group

Description:

IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks

Treatment:

Drug: IMG-007

Cohort 2 IMG-007 Dose 2

Experimental group

Description:

IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks

Treatment:

Drug: IMG-007

Placebo

Placebo Comparator group

Description:

Placebo will be administered intravenously 3 times over 4 weeks

Treatment:

Drug: Placebo