431 Participants Needed

APG777 for Eczema

Recruiting at 182 trial locations
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TC
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Overseen ByMarilia Oliveira
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Apogee Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called APG777 for individuals with moderate-to-severe eczema, also known as atopic dermatitis. The researchers aim to assess the safety and effectiveness of APG777 by testing various doses against a placebo (a treatment with no active drug). Individuals who have struggled with eczema for over a year without relief from creams or ointments might be suitable for this study. Participants will continue using their usual moisturizer and complete itch questionnaires during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to be part of early efficacy testing.

Will I have to stop taking my current medications?

The trial requires that you stop using any AD-related topical medications 7 days before the study starts and any systemic treatments or therapies that could affect AD 4 weeks before the study starts.

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

Research has shown that APG777 has promising safety results from earlier studies. For example, one study found that APG777 achieved its main goals without major safety issues during a 16-week trial, indicating that participants generally handled the treatment well. Another long-term study is ongoing to further assess its safety, suggesting that early results were positive. Since this trial is in Phase 2, the treatment has already passed initial safety tests in earlier phases. While more data will help confirm these findings, current evidence suggests APG777 is well-tolerated by people with moderate-to-severe eczema.12345

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

Most treatments for eczema, like topical steroids and calcineurin inhibitors, focus on reducing inflammation and suppressing the immune response. But APG777 works differently, targeting specific pathways involved in the inflammatory process, potentially offering a more targeted approach. Unlike the standard creams and ointments, APG777 is administered via injection, which might provide longer-lasting relief with less frequent dosing. Researchers are excited about APG777 because it could offer a new way to manage eczema with potentially fewer side effects and improved effectiveness over existing treatments.

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

Research has shown that APG777, which participants in this trial may receive, could be a promising treatment for eczema. In one study, two out of every three patients who used APG777 saw significant improvement in their condition by week 16. Another study found that patients experienced a 71% reduction in eczema severity after 16 weeks, compared to a 33.8% reduction with a placebo. This treatment targets a protein called IL-13, involved in inflammation, suggesting it might effectively reduce eczema symptoms. These findings indicate that APG777 could be a good option for people with moderate-to-severe atopic dermatitis.12367

Are You a Good Fit for This Trial?

This trial is for people with moderate-to-severe Atopic Dermatitis (AD), commonly known as eczema. Participants will be involved in the study for up to 106 weeks, which includes different phases such as screening and treatment follow-ups. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Moderate-to-severe AD at Screening and Baseline visits
I have been diagnosed with Alzheimer's disease for at least 1 year.
Have completed itch questionnaires in the electronic diary for >=4 of 7 days prior to Baseline visit
See 2 more

Exclusion Criteria

I have previously been treated with specific monoclonal antibodies.
I have used skin medication for AD within the last 7 days.
I haven't used any systemic treatments, phototherapies, or laser therapy that could affect my condition in the last 4 weeks.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive APG777 or placebo in various regimens to evaluate safety and efficacy

Duration not specified

Maintenance

Participants continue receiving APG777 in maintenance regimens to evaluate long-term safety and efficacy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • APG777
Trial Overview The trial is testing APG777 against a placebo to see if it's safe and effective for AD. It has two parts: Part A tests one induction dose regimen of APG777 and two maintenance regimens; Part B compares three dose regimens of APG777 with a placebo, including one maintenance regimen.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: Maintenance Period: APG777Experimental Treatment1 Intervention
Group II: Part B: Induction Period: APG777Experimental Treatment1 Intervention
Group III: Part A: Maintenance Period: APG777Experimental Treatment1 Intervention
Group IV: Part A: Induction Period: APG777Experimental Treatment1 Intervention
Group V: Part B: Induction Period: PlaceboPlacebo Group1 Intervention
Group VI: Part A: Induction Period: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Apogee Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
390+

Citations

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 ...
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 ...
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 ...
APG777 Trial Demonstrates Efficacy, Safety in ADTreatment with APG777 led to a significant 71.0% reduction in EASI scores from baseline to week 16, compared to a 33.8% reduction with ...
Apogee claims IL-13 antibody sets new eczema treatment ...Apogee Therapeutics' anti-IL-13 antibody has been tied to a 71% reduction in eczema severity after 16 weeks, hitting the main goal of a phase 2 trial.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40739793/
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 ...
A Study Evaluating APG777 in Atopic DermatitisThis is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD).
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