NCT07734415

Brief 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)

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Jun 2026

Geographic Reach
2 countries

23 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Mar 2028

Study Start

First participant enrolled

June 5, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

June 11, 2026

Last Update Submit

July 24, 2026

Conditions

Atopic DermatitisAtopic Dermatitis EczemaEczema

Keywords

IMG-007Atopic DermatitisDermatitis, AtopicDermatitisEczemaSkin DiseasesImmune System DiseasesDermatologic Agents

Outcome Measures

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

    Baseline, Week 44

Secondary Outcomes (10)

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

    Baseline, Week 44

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

    Baseline, Week 44

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

    Baseline, Week 44

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

    Baseline, Week 44

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

    Baseline, Week 44

  • +5 more secondary outcomes

Study Arms (1)

IMG-007 Dose

EXPERIMENTAL

Subcutaneous injection as per protocol.

Drug: IMG-007

Interventions

IMG-007DRUG

Participants will receive IMG-007 subcutaneously.

IMG-007 Dose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Enrolling by invitation participants with moderate to severe AD who have completed IMG-007-203

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (23)

Inmagene Site 1

Lancaster, California, 93534, United States

Location

Inmagene Site 23

Los Angeles, California, 90095, United States

Location

Inmagene Site 19

Ocala, Florida, 34470, United States

Location

Inmagene Site 4

Tampa, Florida, 33609, United States

Location

Inmagene Site 2

Rolling Meadows, Illinois, 60008, United States

Location

Inmagene Site 6

Kew Gardens, New York, 11415, United States

Location

Inmagene Site 21

New York, New York, 10029, United States

Location

Inmagene Site 11

Woodbury, New York, 11797, United States

Location

Inmagene Site 20

Charlotte, North Carolina, 28277, United States

Location

Inmagene Site 10

Fargo, North Dakota, 58103, United States

Location

Inmagene Site 9

Columbus, Ohio, 43213, United States

Location

Inmagene Site 5

Mayfield Heights, Ohio, 44124, United States

Location

Inmagene Site 3

Portland, Oregon, 97210, United States

Location

Inmagene Site 12

Anderson, South Carolina, 29621, United States

Location

Inmagene Site 8

Southlake, Texas, 76092, United States

Location

Inmagene Site 7

Burien, Washington, 698168, United States

Location

Inmagene Site 15

Surrey, British Columbia, V3R 6A7, Canada

Location

Inmagene Site 22

Vancouver, British Columbia, V6H 4B1, Canada

Location

Inmagene Site 17

Greater Sudbury, Ontario, P3C 1X8, Canada

Location

Inmagene Site 13

Mississauga, Ontario, L4Y 4C5, Canada

Location

Inmagene Site 18

North Bay, Ontario, P1B 3Z7, Canada

Location

Inmagene Site 14

Montreal, Quebec, H2X 2V1, Canada

Location

Inmagene Site 16

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczemaDermatitisSkin DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivity

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

July 29, 2026

Study Start

June 5, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations

CA(7)US(16)