APG777 for Atopic Dermatitis

Recruiting at 28 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Apogee Therapeutics, Inc.

Disqualifiers: Adverse events, Early termination, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the experimental treatment APG777 is safe and effective for individuals with moderate-to-severe atopic dermatitis over an extended period. It involves participants who completed a previous study with APG777 and experienced positive outcomes. These participants will continue their treatment to assess its long-term effectiveness. Individuals diagnosed with atopic dermatitis who finished the earlier study without requiring additional medication are well-suited for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any prohibited medications from the Parent Study during the Screening Visit of this study.

Is there any evidence suggesting that APG777 is likely to be safe for humans?

Research has shown that APG777 was safe in earlier studies. After 16 weeks, patients with moderate-to-severe atopic dermatitis (AD) who took APG777 experienced few side effects. Most side effects were mild to moderate, and patients generally tolerated the treatment well. The most common side effect was a reaction at the injection site, typical for treatments administered this way. No serious side effects related to the treatment were reported in these studies. APG777 is a new type of antibody that targets IL-13, a protein involved in inflammation, to help reduce AD symptoms. The ongoing long-term study aims to confirm these safety results over a longer period. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for atopic dermatitis?

Researchers are excited about APG777 for atopic dermatitis because it offers a unique approach compared to traditional treatments like topical corticosteroids and calcineurin inhibitors. Unlike these standard therapies that primarily address inflammation, APG777 is designed to target specific pathways involved in the skin's immune response, potentially offering more precise relief. Additionally, APG777 is administered via injections, which could provide a longer-lasting effect than topical treatments, reducing the frequency of application and potentially improving adherence. This new method of action and delivery could be a game-changer for patients seeking more effective and convenient solutions for managing atopic dermatitis.

What evidence suggests that APG777 might be an effective treatment for atopic dermatitis?

Research has shown that APG777 effectively treats moderate-to-severe atopic dermatitis, also known as eczema. In a recent study, two out of every three participants experienced a 75% or greater improvement in eczema symptoms after 16 weeks. The treatment also resulted in a significant 71% reduction in eczema severity scores, compared to a 33.8% reduction in those who did not receive the treatment. These findings suggest that APG777 may provide significant relief for people with eczema. Participants in this trial will receive APG777 in different treatment arms, including a long-term extension treatment for either 12 or 24 weeks, or an open-label escape arm for those who did not achieve desired results in the parent study. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with moderate-to-severe atopic dermatitis who finished treatment in a previous APG777 study and could benefit from continued use, as determined by the researcher.

Inclusion Criteria

Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol

Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777

I have been using the same moisturizer since the end of the last study and will continue to do so.

Exclusion Criteria

Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient

I haven't taken any prohibited medications from the main study up to the first visit of the long-term extension study.

I don't have skin conditions that could affect the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Coincides with last visit of Parent Study

Extended Treatment

Participants receive long-term treatment with APG777, maintaining the same dose regimen from the Parent Study

12-24 weeks

Open Label Escape Arm

Participants who did not achieve EASI 75 or used rescue medication receive APG777 per protocol defined dosing regimen

Post-treatment Follow-up

Participants are monitored for safety and effectiveness after treatment

Average of 2 years

What Are the Treatments Tested in This Trial?

Interventions

• APG777

Trial Overview The long-term safety and effectiveness of APG777 for atopic dermatitis are being tested. Participants will go through an extended treatment period after initial screening, followed by post-treatment follow-up.

How Is the Trial Designed?

Group I: APG777 - Open Label Escape Arm Experimental Treatment 1 Intervention

Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen.

Group II: APG777 - Long Term Extension Treatment - 24 Weeks Experimental Treatment 1 Intervention

Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).

Group III: APG777 - Long Term Extension Treatment - 12 Weeks Experimental Treatment 1 Intervention

Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).

Who Is Running the Clinical Trial?

Apogee Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

390+

Citations

1. investors.apogeetherapeutics.com investors.apogeetherapeutics.com/news-releases/news-release-details/apogee-therapeutics-announces-late-breaker-presentation-16-week

Release Details - Investor Relations | Apogee Therapeutics, Inc. “In July, we announced 16-week topline data from the APEX clinical trial, in which APG777 met the primary and secondary endpoints, reinforcing ...

2. investors.apogeetherapeutics.com investors.apogeetherapeutics.com/news-releases/news-release-details/apogee-therapeutics-announces-positive-16-week-data-phase-2-apex

Release Details - Investor Relations | Apogee Therapeutics, Inc. “With two out of every three patients treated with APG777 achieving EASI-75 response at Week 16 in the Phase 2 APEX Part A trial, APG777 ...

3. dermatologytimes.com dermatologytimes.com/view/apg777-trial-demonstrates-efficacy-safety-in-ad

APG777 Trial Demonstrates Efficacy, Safety in AD Treatment with APG777 led to a significant 71.0% reduction in EASI scores from baseline to week 16, compared to a 33.8% reduction with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06395948

A Study Evaluating APG777 in Atopic Dermatitis This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD).

5. clinicaltrial.be clinicaltrial.be/en/details/435205?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Study Evaluating APG777 in Atopic Dermatitis This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07003425

A Long-term Safety and Efficacy Study Evaluating APG777 ... This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/10915818251355584

Preclinical Safety of APG777, A Novel Extended Half-Life ... The safety and efficacy of APG777 are currently being investigated in a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe ...