ClinicalTrials.gg
RecruitingNCT07037901ADAPTIVEUpdated Aug 12, 2026

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

A Phase 2 interventional study of IMG-007 and Placebo in Atopic Dermatitis, Atopic Dermatitis Eczema and Eczema, sponsored by Inmagene LLC. Recruiting at 30 sites in 4 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Inmagene LLC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
405
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Atopic Dermatitis
  • Atopic Dermatitis Eczema
  • Eczema

Keywords

  • IMG-007
  • Atopic Dermatitis
  • Dermatitis, Atopic
  • Dermatitis
  • Eczema
  • Skin Diseases
  • Immune System Diseases
  • Dermatologic Agents
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 405 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Inmagene LLC is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 or of childbearing potential and agrees to use a highly effective method of
  • 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 , , or 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
405 participants (estimated)

Study arms

  • Experimental
    IMG-007 Dose 1

    Subcutaneous injection as per protocol.

    Drug: IMG-007

  • Experimental
    IMG-007 Dose 2

    Subcutaneous injection as per protocol.

    Drug: IMG-007

  • Experimental
    IMG-007 Dose 3

    Subcutaneous injection as per protocol.

    Drug: IMG-007

  • Experimental
    IMG-007 Dose 4

    Subcutaneous injection as per protocol.

    Drug: IMG-007

  • Experimental
    IMG-007 Dose 5

    Subcutaneous injection as per protocol.

    Drug: IMG-007

  • Experimental
    IMG-007 Dose 6

    Subcutaneous injection as per protocol.

    Drug: IMG-007

  • Experimental
    IMG-007 Dose 7

    Subcutaneous injection as per protocol.

    Drug: IMG-007

  • Placebo comparator
    Placebo Crossover Dose 1

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

    Drug: IMG-007 · Drug: Placebo

  • Placebo comparator
    Placebo Crossover Dose 2

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

    Drug: IMG-007 · Drug: Placebo

Interventions

  • Participants will receive IMG-007 subcutaneously.

  • DrugPlacebo

    Participants will receive a placebo subcutaneously.

06

What researchers measure

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

07

Study locations

23 of 30 sites recruiting
  • Inmagene Site 1
    Lancaster, California 93534, United States
    Recruiting
  • Inmagene Site 23
    Los Angeles, California 90095, United States
    Recruiting
  • Inmagene Site 19
    Ocala, Florida 34470, United States
    Recruiting
  • Inmagene Site 4
    Tampa, Florida 33609, United States
    Recruiting
  • Inmagene Site 2
    Rolling Meadows, Illinois 60008, United States
    Recruiting
  • Inmagene Site 6
    Kew Gardens, New York 11415, United States
    Recruiting
  • Inmagene Site 21
    New York, New York 10029, United States
    Recruiting
  • Inmagene Site 11
    Woodbury, New York 11797, United States
    Recruiting
  • Inmagene Site 20
    Charlotte, North Carolina 28277, United States
    Recruiting
  • Inmagene Site 10
    Fargo, North Dakota 58103, United States
    Recruiting
  • Inmagene Site 9
    Columbus, Ohio 43213, United States
    Recruiting
  • Inmagene Site 5
    Mayfield Heights, Ohio 44124, United States
    Recruiting
  • Inmagene Site 3
    Portland, Oregon 97210, United States
    Recruiting
  • Inmagene Site 12
    Anderson, South Carolina 29621, United States
    Recruiting
  • Inmagene Site 8
    Southlake, Texas 76092, United States
    Recruiting
  • Inmagene Site 7
    Burien, Washington 698168, United States
    Recruiting
  • Inmagene Site 25
    Woden, Australian Capital Territory 2606, Australia
    Not yet recruiting
  • Inmagene Site 28
    Liverpool, New South Wales 2170, Australia
    Not yet recruiting
  • Inmagene Site 26
    Benowa, Queensland 4217, Australia
    Not yet recruiting
  • Inmagene Site 27
    Carlton, Victoria 3053, Australia
    Not yet recruiting
  • Inmagene Site 24
    Mitcham, Victoria 3132, Australia
    Not yet recruiting
  • Inmagene Site 15
    Surrey, British Columbia V3R 6A7, Canada
    Recruiting
  • Inmagene Site 22
    Vancouver, British Columbia V6H 4B1, Canada
    Recruiting
  • Inmagene Site 17
    Greater Sudbury, Ontario P3C 1X8, Canada
    Recruiting
  • Inmagene Site 13
    Mississauga, Ontario L4Y 4C5, Canada
    Recruiting
  • Inmagene Site 18
    North Bay, Ontario P1B 3Z7, Canada
    Recruiting
  • Inmagene Site 14
    Montreal, Quebec H2X 2V1, Canada
    Recruiting
  • Inmagene Site 16
    Saskatoon, Saskatchewan S7K 2C1, Canada
    Recruiting
  • Inmagene Site 29
    Hamilton, Waikato Region 3204, New Zealand
    Not yet recruiting
  • Inmagene Site 30
    Auckland, 1051, New Zealand
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07037901
Lead sponsor
Inmagene LLC
Responsible party
Sponsor
First posted
Jun 26, 2025
Start date
Jun 17, 2025
Primary completion
Dec 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Aug 12, 2026

Study contacts

ADAPTIVE Study Lead
Contact
ADAPTIVE_StudyLead@imagenebio.com
(858) 345-6927

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: IMG-007

Start the discussion