A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
ADAPTIVE
A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
1 other identifier
interventional
220
2 countries
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2025
23 active sites
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
First Submitted
Initial submission to the registry
June 17, 2025
CompletedStudy Start
First participant enrolled
June 17, 2025
CompletedFirst Posted
Study publicly available on registry
June 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
February 19, 2026
February 1, 2026
1.4 years
June 17, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean percent change from baseline in EASI at Week 20
Baseline, Week 20
Secondary Outcomes (4)
Mean percent change from baseline in EASI at Week 16
Baseline, Week 16
Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 16 and Week 20, respectively
Week 16, Week 20
Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 16 and Week 20, respectively
Week 16, Week 20
Incidence and severity of TEAE including treatment-emergent SAEs
Baseline, End of Study
Study Arms (4)
IMG-007 dose 1
EXPERIMENTALSubcutaneous injection as per protocol.
IMG-007 dose 2
EXPERIMENTALSubcutaneous injection as per protocol.
IMG-007 dose 3
EXPERIMENTALSubcutaneous injection as per protocol.
Placebo Crossover
PLACEBO COMPARATORSubcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inmagene LLClead
Study Sites (23)
Antelope Valley Clinical Trials
Lancaster, California, 93534, United States
UCLA Division of Dermatology
Los Angeles, California, 90095, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida, 33609, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11415, United States
Inmagene Site 1
New York, New York, 10029, United States
Vitality Clinical Trials LLC
Woodbury, New York, 11797, United States
Darst Dermatology
Charlotte, North Carolina, 28277, United States
Red River Research Partners, LLC
Fargo, North Dakota, 58103, United States
ClinOhio Research Services LLC.
Columbus, Ohio, 43213, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina, 29621, United States
Stryde Research-Epiphany Dermatology
Southlake, Texas, 76092, United States
Dermatology of Seattle & Bellevue
Burien, Washington, 698168, United States
Dr. Chin-ho-Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
PacificDerm
Vancouver, British Columbia, V6H 4B1, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8, Canada
DermEdge Research
Mississauga, Ontario, L4Y 4C5, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- 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)
November 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
February 19, 2026
Record last verified: 2026-02