Recruiting
Phase 2

IMG-007

Sponsor:

Inmagene LLC

Code:

NCT07037901

Conditions

Atopic Dermatitis

Atopic Dermatitis Eczema

Eczema

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IMG-007

Placebo

Study Details

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

Study ID

NCT07037901

Start date

Jun 17, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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

Key Exclusion Criteria:

  • 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

Study Design

Enrollment

405 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IMG-007 Dose 1

Subcutaneous injection as per protocol.

experimental: IMG-007 Dose 2

Subcutaneous injection as per protocol.

experimental: IMG-007 Dose 3

Subcutaneous injection as per protocol.

experimental: IMG-007 Dose 4

Subcutaneous injection as per protocol.

experimental: IMG-007 Dose 5

Subcutaneous injection as per protocol.

experimental: IMG-007 Dose 6

Subcutaneous injection as per protocol.

experimental: IMG-007 Dose 7

Subcutaneous injection as per protocol.

placebo comparator: Placebo Crossover Dose 1

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

placebo comparator: Placebo Crossover Dose 2

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

Interventions

IMG-007

Participants will receive IMG-007 subcutaneously.

Placebo

Participants will receive a placebo subcutaneously.

Primary outcome measure

  • Mean percent change from baseline in EASI at Week 24 [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

ADAPTIVE Study Lead

(858) 345-6927ADAPTIVE_StudyLead@imagenebio.com

Locations

Inmagene Site 1

Recruiting

Lancaster, California, United States, 93534

Inmagene Site 23

Recruiting

Los Angeles, California, United States, 90095

Inmagene Site 19

Recruiting

Ocala, Florida, United States, 34470

Inmagene Site 4

Recruiting

Tampa, Florida, United States, 33609

Inmagene Site 2

Recruiting

Rolling Meadows, Illinois, United States, 60008

Inmagene Site 6

Recruiting

Kew Gardens, New York, United States, 11415

Inmagene Site 21

Recruiting

New York, New York, United States, 10029

Inmagene Site 11

Recruiting

Woodbury, New York, United States, 11797

Inmagene Site 20

Recruiting

Charlotte, North Carolina, United States, 28277

Inmagene Site 10

Recruiting

Fargo, North Dakota, United States, 58103

Inmagene Site 9

Recruiting

Columbus, Ohio, United States, 43213

Inmagene Site 5

Recruiting

Mayfield Heights, Ohio, United States, 44124

Inmagene Site 3

Recruiting

Portland, Oregon, United States, 97210

Inmagene Site 12

Recruiting

Anderson, South Carolina, United States, 29621

Inmagene Site 8

Recruiting

Southlake, Texas, United States, 76092

Inmagene Site 7

Recruiting

Burien, Washington, United States, 698168

Inmagene Site 15

Recruiting

Surrey, British Columbia, Canada, V3R 6A7

Inmagene Site 22

Recruiting

Vancouver, British Columbia, Canada, V6H 4B1

Inmagene Site 17

Recruiting

Greater Sudbury, Ontario, Canada, P3C 1X8

Inmagene Site 13

Recruiting

Mississauga, Ontario, Canada, L4Y 4C5

Inmagene Site 18

Recruiting

North Bay, Ontario, Canada, P1B 3Z7

Inmagene Site 14

Recruiting

Montreal, Quebec, Canada, H2X 2V1

Inmagene Site 16

Recruiting

Saskatoon, Saskatchewan, Canada, S7K 2C1

More Information

Sponsor

Inmagene LLC

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Inmagene LLC on 2026-08-12.