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

NCT07037901 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IMG-007-203
• Study Type: interventional
• Target: 405
• Locations: 2 countries
• Sites: 23

Brief Summary

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

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema; Eczema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean percent change from baseline in EASI at Week 24

  Baseline, Week 24

Secondary Outcomes (4)

• 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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

• Incidence and severity of TEAE including treatment-emergent SAEs

  Baseline, End of Study

Study Arms (9)

IMG-007 Dose 1

EXPERIMENTAL

Subcutaneous injection as per protocol.

Drug: IMG-007

IMG-007 Dose 2

EXPERIMENTAL

Subcutaneous injection as per protocol.

Drug: IMG-007

IMG-007 Dose 3

EXPERIMENTAL

Subcutaneous injection as per protocol.

Drug: IMG-007

IMG-007 Dose 4

EXPERIMENTAL

Subcutaneous injection as per protocol.

Drug: IMG-007

IMG-007 Dose 5

EXPERIMENTAL

Subcutaneous injection as per protocol.

Drug: IMG-007

IMG-007 Dose 6

EXPERIMENTAL

Subcutaneous injection as per protocol.

Drug: IMG-007

IMG-007 Dose 7

EXPERIMENTAL

Subcutaneous injection as per protocol.

Drug: IMG-007

Placebo Crossover Dose 1

PLACEBO COMPARATOR

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

Drug: IMG-007; Drug: Placebo

Placebo Crossover Dose 2

PLACEBO COMPARATOR

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

Drug: IMG-007; Drug: Placebo

Interventions

IMG-007 DRUG

Participants will receive IMG-007 subcutaneously.

IMG-007 Dose 1; IMG-007 Dose 2; IMG-007 Dose 3; IMG-007 Dose 4; IMG-007 Dose 5; IMG-007 Dose 6; IMG-007 Dose 7; Placebo Crossover Dose 1; Placebo Crossover Dose 2

Placebo DRUG

Participants will receive a placebo subcutaneously.

Placebo Crossover Dose 1; Placebo Crossover Dose 2

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Inmagene LLC: lead

Study Sites (23)

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 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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Dermatitis; Skin Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity

Central Study Contacts

ADAPTIVE Study Lead

CONTACT

(858) 345-6927; ADAPTIVE_StudyLead@imagenebio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 26, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

US (16); CA (7)