Tests IMG-007 doses in adults with moderate-to-severe atopic dermatitis
Tests different IMG-007 doses against placebo in adults with atopic dermatitis.
Key facts
- Who runs it
- Inmagene LLC
- Where
- Moravska Ostrava A Privoz, Nový Jičín, Pardubice I, Prague, and Prague 10, CzechiaSee the 8 sitesAlso in 8 other countries, 77 sites
- Trial code
- Registry title
- A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 405 people, planned
- Started
- 17 Jun 2025
- Expected to end
- Aug 2028
- Type of study
- Interventional, 9 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- IMG-007
- Placebo
- Record updated
- 12 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate-to-severe atopic dermatitis (eczema) who did not respond well to, or could not tolerate, topical treatments.
- Age
- 18 to 74 years
- Sex
- All sexes can join.
- Disease stage
- Moderate-to-severe atopic dermatitis: EASI score ≥16, vIGA-AD score ≥3, ≥10% of body surface area affected, and mean peak itch score ≥ 4 in the 7 days before randomization.
- Earlier treatment
- Must have had an inadequate response or poor tolerance to a stable regimen of one or more topical treatments before screening, or topical treatments are otherwise inadvisable.
Main reasons for not taking part
- Positive hepatitis B, hepatitis C, or HIV infection
- Active or latent tuberculosis, or past untreated or inadequately treated TB infection
- Active infection needing systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals
- Other active unstable itchy skin conditions that would interfere with assessing AD
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals
- Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit
- 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 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Where in Czechia
Also in 8 other countries, 77 sites
- CCR Ostrava s.r.o.Moravska Ostrava A Privoz, CzechiaNot yet recruiting
- Nemocnice AGEL Nový Jičín a.s.Nový Jičín, CzechiaNot yet recruiting
- Pratia Czech s.r.o.Pardubice I, CzechiaNot yet recruiting
- Dermatovenerologicka ordinace MUDr. Blanka HavlickovaPrague, CzechiaNot yet recruiting
- Fakultni nemocnice BulovkaPrague, CzechiaNot yet recruiting
- Praglandia s.r.o.Prague, CzechiaNot yet recruiting
- Pratia Czech, s.r.o.Prague, CzechiaNot yet recruiting
- Clintrial s.r.o.Prague 10, CzechiaNot yet recruiting
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
The 9 groups in the trial
- IMG-007 Dose 1Treatment being tested
Subcutaneous injection as per protocol.
Treatment: IMG-007
- IMG-007 Dose 2Treatment being tested
Subcutaneous injection as per protocol.
Treatment: IMG-007
- IMG-007 Dose 3Treatment being tested
Subcutaneous injection as per protocol.
Treatment: IMG-007
- IMG-007 Dose 4Treatment being tested
Subcutaneous injection as per protocol.
Treatment: IMG-007
- IMG-007 Dose 5Treatment being tested
Subcutaneous injection as per protocol.
Treatment: IMG-007
- IMG-007 Dose 6Treatment being tested
Subcutaneous injection as per protocol.
Treatment: IMG-007
- IMG-007 Dose 7Treatment being tested
Subcutaneous injection as per protocol.
Treatment: IMG-007
- Placebo Crossover Dose 1Placebo, for comparison
Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
Treatment: IMG-007 and Placebo
- Placebo Crossover Dose 2Placebo, for comparison
Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
Treatment: IMG-007 and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests IMG-007 doses in adults with moderate-to-severe atopic dermatitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07037901, who can take part
- Record updated
- 12 August 2026