A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT07037901
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2025-06-17
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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IMG-007 dose 1
Subcutaneous injection as per protocol.
IMG-007
Participants will receive IMG-007 subcutaneously.
IMG-007 dose 2
Subcutaneous injection as per protocol.
IMG-007
Participants will receive IMG-007 subcutaneously.
IMG-007 dose 3
Subcutaneous injection as per protocol.
IMG-007
Participants will receive IMG-007 subcutaneously.
Placebo Crossover
Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
IMG-007
Participants will receive IMG-007 subcutaneously.
Placebo
Participants will receive a placebo subcutaneously.
Interventions
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IMG-007
Participants will receive IMG-007 subcutaneously.
Placebo
Participants will receive a placebo subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
74 Years
ALL
No
Sponsors
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Inmagene LLC
INDUSTRY
Responsible Party
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Locations
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Antelope Valley Clinical Trials
Lancaster, California, United States
Renstar Medical Research
Ocala, Florida, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Inmagene Site 1
New York, New York, United States
Vitality Clinical Trials LLC
Woodbury, New York, United States
Darst Dermatology
Charlotte, North Carolina, United States
Red River Research Partners, LLC
Fargo, North Dakota, United States
ClinOhio Research Services LLC.
Columbus, Ohio, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina, United States
Stryde Research-Epiphany Dermatology
Southlake, Texas, United States
Dermatology of Seattle & Bellevue
Burien, Washington, United States
Dr. Chin-ho-Hong Medical Inc.
Surrey, British Columbia, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Other Identifiers
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IMG-007-203
Identifier Type: -
Identifier Source: org_study_id