A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis (ADAPTIVE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Inmagene LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2025-09-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Inmagene LLC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Safety, Pharmacodynamic, Therapy, Efficacy, Pharmacokinetic

• To evaluate the effect of different dose regimens of IMG-007, compared to placebo, on disease activity, as measured by Eczema Area and Severity Index (EASI) in participants with moderate to-severe atopic dermatitis (AD), at the end of the placebo-controlled treatment period

Secondary objectives 2

1. • To evaluate the effect of different dose regimens of IMG-007, compared to placebo, on disease activity, as measured by EASI and Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) in AD participants, during the placebo-controlled treatment period
2. • To evaluate the safety profile of different regimens of IMG-007 in AD participants

Conditions and MedDRA coding

Atopic Dermatitis

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. • Male or female aged ≥ 18 and < 75 years
2. • Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study
3. • Diagnosis of AD (according to the American Academy of Dermatology Consensus diagnostic criteria) that has been present for at least 1 year before the Screening visit
4. • Active moderate-to-severe AD
5. • Documented history of inadequate response to or lack of tolerability of, as assessed by the investigator, a stable regimen (≥ 4 weeks) of one or more topical treatments, e.g., topical corticosteroids (TCSs) and/or topical calcineurin inhibitors (TCIs) before the Screening visit, or for whom topical treatments are otherwise inadvisable
6. • Agree to apply a stable dose of a non-medicated emollient (moisturizer)
7. • Female participants must not be pregnant or breastfeeding and must meet at least one of the following conditions: a) Not of childbearing potential, OR b) Of childbearing potential and agree to use a highly effective method of contraception
8. • Male participants must agree to use a highly effective method of contraception or must be surgically sterilized

Exclusion criteria 8

1. • Severe cardiovascular, pulmonary, renal, autoimmune, or metabolic illness(es), or any other acute or chronic medical or psychiatric condition or laboratory abnormality
2. • History of clinically significant abnormal laboratory values
3. • Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology results at Screening visit
4. • Evidence of active or latent tuberculosis (TB) as confirmed by the screening TB blood test
5. • History of untreated or inadequately treated TB infection
6. • Active infection (including skin infection) requiring treatment with topical or systemic antibiotics, antivirals, antifungals, antiparasitic or antiprotozoals within 2 weeks prior to the Baseline (Day 1) visit.
7. • Active unstable (e.g., in an acute flare) pruritic skin conditions or other skin diseases in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgment
8. • Previous participation in a study using IMG-007 as the study treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean percent change from baseline in EASI at Week 20

Secondary endpoints 4

1. • Mean percent change from baseline in EASI at Week 16
2. • Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 16 and Week 20, respectively
3. • 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
4. • Incidence and severity of TEAE including treatment-emergent SAEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inmagene LLC

Sponsor organisation

Inmagene LLC

Address

12526 High Bluff Drive Ste 345

City

San Diego

Postcode

92130-3015

Country

United States

Scientific contact point

Organisation

Inmagene LLC

Contact name

ADAPTIVE Study Lead

Public contact point

Organisation

Inmagene LLC

Contact name

ADAPTIVE Study Lead

Third parties 16

Locations

5 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 101 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications