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

Sponsored by Inmagene LLC

About this trial

Last updated 2 years ago

Study ID

IMG-007-201

Status

Recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 74 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 months ago

What is this trial 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.

What are the Participation Requirements?

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting