IMG-007 for Eczema

(ADAPTIVE Trial)

Recruiting at 18 trial locations

Overseen By ADAPTIVE Study Lead

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Inmagene LLC

Must not be taking: Antibiotics, Antivirals, Antifungals, Antiprotozoals

Disqualifiers: Hepatitis, HIV, Tuberculosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IMG-007, an experimental therapy, to evaluate its effectiveness and safety for people with eczema, a condition causing itchy and inflamed skin. Researchers compare different doses of IMG-007 to a placebo, which contains no active drug, to identify the best option. Candidates for this trial have moderate-to-severe eczema and have not responded to other skin treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in eczema treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that IMG-007 is likely to be safe for humans?

Research has shown that IMG-007 has been safe in previous studies. In one study, healthy participants took single doses of IMG-007 up to 600 mg, and these doses were well-tolerated and remained in the body for an extended period. Another study found that the form of IMG-007 administered under the skin was also safe and demonstrated strong safety results. While these findings are encouraging, it is important to remember that this trial is still in the early stages of testing for eczema. Safety information is still being collected, but no major safety issues have been reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about IMG-007 for eczema because it offers a fresh approach by targeting specific pathways in the immune system. Unlike current treatments like topical corticosteroids or calcineurin inhibitors, which mainly reduce inflammation, IMG-007 is a biologic that modulates immune responses more precisely, potentially reducing flare-ups and skin irritation with fewer side effects. Additionally, its subcutaneous injection delivery method ensures that the medication is efficiently absorbed, which could lead to quicker and more consistent relief for patients. This innovative mechanism and delivery method position IMG-007 as a promising new option in eczema care.

What evidence suggests that IMG-007 might be an effective treatment for eczema?

Studies have shown that IMG-007 can effectively treat eczema. In a previous study, using IMG-007 for 4 weeks led to a 77% reduction in the size and severity of eczema, as measured by a standard tool. Additionally, 54% of patients experienced at least a 75% improvement in their eczema. IMG-007 targets a specific part of the immune system to help reduce inflammation. These early results suggest that IMG-007 has the potential to significantly improve eczema symptoms. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe atopic dermatitis, commonly known as eczema. Participants should have a history of the condition and meet specific criteria that will be detailed by the study organizers.

Inclusion Criteria

Moderate-to-severe AD

Topical treatments have not worked for me or I cannot use them.

vIGA-AD score ≥3

Exclusion Criteria

Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection

I have signs of active or latent TB.

I have had TB that was not treated or not treated properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various dose regimens of IMG-007 or placebo for up to 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IMG-007

Trial Overview The trial is testing different doses of IMG-007 to see how well it works compared to a placebo (a treatment with no active drug). The goal is to find out if IMG-007 can improve skin conditions in those with atopic dermatitis.

How Is the Trial Designed?

Group I: IMG-007 dose 3 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol.

Group II: IMG-007 dose 2 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol.

Group III: IMG-007 dose 1 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol.

Group IV: Placebo Crossover Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Inmagene LLC

Lead Sponsor

Trials

6

Recruited

200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07037901

A Study to Evaluate the Efficacy and Safety of IMG-007 in ... The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.

2. academic.oup.com academic.oup.com/bjd/article-abstract/191/Supplement_2/ljae266.076/7728601

702 - IMG-007, a nondepleting OX40 monoclonal antibody ... Key endpoints included safety and efficacy as measured by EASI, IGA, BSA, and SCORing atopic dermatitis (SCORAD) index. Results. A total of 13 ...

3. imagenebio.com imagenebio.com/press_releases/inmagene-reports-positive-topline-results-of-img-007-a-nondepleting-anti-ox40-monoclonal-antibody-with-an-extended-half-life-for-the-treatment-of-atopic-dermatitis/

Inmagene Reports Positive Topline Results of IMG-007, a ... A 4-week treatment with IMG-007 resulted in a mean reduction in eczema area and severity index (EASI) of 77% and EASI-75 response of 54%, ...

4. hcplive.com hcplive.com/view/new-phase-2a-findings-released-img-007-treatment-atopic-dermatitis

New Phase 2a Findings Released on IMG-007 Treatment ... New topline data released by Inmagene indicate positive findings from a phase 2a trial on IMG-007 for moderate-to-severe atopic dermatitis.

5. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress_2024/47373.pdf

Abstract N°: 5899 Safety and efficacy of IMG-007, a ... OX40 antagonists have shown efficacy in treating atopic dermatitis (AD). IMG-007 is a nondepleting OX40 antibody with a Fc N297A mutation designed to ...

6. annallergy.org annallergy.org/article/S1081-1206(23)00886-4/fulltext

SAFETY AND PHARMACOKINETICS OF IMG-007, AN ... Single doses of IMG-007 up to 600 mg were well-tolerated in healthy participants and exhibited an extended half-life at high doses.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120623008864

p286 safety and pharmacokinetics of img-007, an ox40 ... Single doses of IMG-007 up to 600 mg were well-tolerated in healthy participants and exhibited an extended half-life at high doses.