ClinicalTrials.gg
Enrolling by invitationNCT07734415Updated Jul 29, 2026

Long-term Safety and Efficacy Evaluation of IMG-007 in Participants With Moderate-to-Severe Atopic Dermatitis

A Phase 2 interventional study of IMG-007 in Atopic Dermatitis, Atopic Dermatitis Eczema and Eczema, sponsored by Inmagene LLC. Enrolling by invitation at 23 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

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

Phase
Phase 2
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD)

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 400 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 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Enrolling by invitation participants with moderate to severe AD who have completed IMG-007-203

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    IMG-007 Dose

    Subcutaneous injection as per protocol.

    Drug: IMG-007

Interventions

  • Participants will receive IMG-007 subcutaneously.

06

What researchers measure

Primary outcomes

  1. Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis

    Incidence and severity of TEAEs, including treatment-emergent SAEs, AESIs, and AEs leading to discontinuation

    Time frame: Baseline, Week 44

Secondary outcomes

  1. Characterize the safety of long-term treatment with IMG-007 based on body temperature (Celsius)

    Time frame: Baseline, Week 44

  2. Characterize the safety of long-term treatment with IMG-007 based on pulse rate (beats per minute)

    Time frame: Baseline, Week 44

  3. Characterize the safety of long-term treatment with IMG-007 based on respiratory rate (breaths per minute)

    Time frame: Baseline, Week 44

  4. Characterize the safety of long-term treatment with IMG-007 based on blood pressure (systolic and diastolic) (mmHg)

    Time frame: Baseline, Week 44

  5. Number of Participants With Clinically Significant Abnormal (defined by rate, rhythm, morphology, and conduction abnormalities) ECG Findings (unit is number of participants).

    Time frame: Baseline, Week 44

  6. Characterize the safety of long-term treatment with IMG-007, as assessed by hematology

    Time frame: Baseline, Week 44

  7. Characterize the safety of long-term treatment with IMG-007, as assessed by blood chemistry

    Time frame: Baseline, Week 44

  8. Characterize the safety of long-term treatment with IMG-007, as assessed by urinalysis

    Time frame: Baseline, Week 44

  9. Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Eczema Area and Severity Index (EASI)

    Time frame: Baseline, Week 44

  10. Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)

    Time frame: Baseline, Week 44

07

Study locations

23 sites
  • Inmagene Site 1
    Lancaster, California 93534, United States
  • Inmagene Site 23
    Los Angeles, California 90095, United States
  • Inmagene Site 19
    Ocala, Florida 34470, United States
  • Inmagene Site 4
    Tampa, Florida 33609, United States
  • Inmagene Site 2
    Rolling Meadows, Illinois 60008, United States
  • Inmagene Site 6
    Kew Gardens, New York 11415, United States
  • Inmagene Site 21
    New York, New York 10029, United States
  • Inmagene Site 11
    Woodbury, New York 11797, United States
  • Inmagene Site 20
    Charlotte, North Carolina 28277, United States
  • Inmagene Site 10
    Fargo, North Dakota 58103, United States
  • Inmagene Site 9
    Columbus, Ohio 43213, United States
  • Inmagene Site 5
    Mayfield Heights, Ohio 44124, United States
  • Inmagene Site 3
    Portland, Oregon 97210, United States
  • Inmagene Site 12
    Anderson, South Carolina 29621, United States
  • Inmagene Site 8
    Southlake, Texas 76092, United States
  • Inmagene Site 7
    Burien, Washington 698168, United States
  • Inmagene Site 15
    Surrey, British Columbia V3R 6A7, Canada
  • Inmagene Site 22
    Vancouver, British Columbia V6H 4B1, Canada
  • Inmagene Site 17
    Greater Sudbury, Ontario P3C 1X8, Canada
  • Inmagene Site 13
    Mississauga, Ontario L4Y 4C5, Canada
  • Inmagene Site 18
    North Bay, Ontario P1B 3Z7, Canada
  • Inmagene Site 14
    Montreal, Quebec H2X 2V1, Canada
  • Inmagene Site 16
    Saskatoon, Saskatchewan S7K 2C1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07734415
Lead sponsor
Inmagene LLC
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Jun 5, 2026
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Jul 29, 2026

Oversight

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

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Studies of the drug tested here: IMG-007

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