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

ConditionsAtopic DermatitisAtopic Dermatitis EczemaEczema
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorInmagene LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • IMG-007

    Drug

    Participants will receive IMG-007 subcutaneously.

  • Placebo

    Drug

    Participants will receive a placebo subcutaneously.

Treatment groups

405 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: IMG-007 Dose 1Experimental treatment 1 intervention
Group B: IMG-007 Dose 2Experimental treatment 1 intervention
Group C: IMG-007 Dose 3Experimental treatment 1 intervention
Group D: IMG-007 Dose 4Experimental treatment 1 intervention
Group E: IMG-007 Dose 5Experimental treatment 1 intervention
Group F: IMG-007 Dose 6Experimental treatment 1 intervention
Group G: IMG-007 Dose 7Experimental treatment 1 intervention
Group H: Placebo Crossover Dose 1Placebo comparator 2 interventions
Group I: Placebo Crossover Dose 2Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mean percent change from baseline in EASI at Week 24

Time frame
Baseline, Week 24

Secondary outcomes

1

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
2

Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24

Time frame
Baseline, Week 24
3

Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24

Time frame
Baseline, Week 24
4

Incidence and severity of TEAE including treatment-emergent SAEs

Time frame
Baseline, End of Study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inmagene LLC

Lead sponsor

Source ClinicalTrials.gov
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