50 Participants Needed

APG777 + APG990 for Atopic Dermatitis

Recruiting at 18 trial locations
SD
Overseen ByStudy Director
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination, APG777 and APG990, for individuals with moderate-to-severe atopic dermatitis, a type of eczema that causes itchy and inflamed skin. The goal is to determine the safety and effectiveness of these medications compared to an existing treatment, dupilumab. Participants will be involved for about 82 weeks, including time for screening, treatment, and follow-up. This study may suit adults who have had atopic dermatitis for at least a year, with symptoms not well controlled by creams or ointments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using any topical medications for atopic dermatitis 7 days before starting and any systemic treatments or therapies that could affect atopic dermatitis 4 weeks before starting. It's best to discuss your current medications with the study team to see if they are affected.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that APG990 is generally safe. One study found that it remains in the body for about 60 days and is well-tolerated, making it a promising treatment for atopic dermatitis. This suggests it might only need administration every 3-6 months, reducing the number of doses required.

For APG777, earlier trials showed positive results in patients with moderate-to-severe atopic dermatitis. Although specific safety details for APG777 alone weren't highlighted, its progression to later trials suggests it was well-tolerated in earlier studies.

The current trial examines the safety and tolerability of these two treatments when used together. Since this trial is in the early stages, it primarily focuses on how well participants handle taking both drugs simultaneously.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of APG777 and APG990 for atopic dermatitis because it brings a fresh approach to treatment. Unlike standard options like Dupilumab, which typically target immune pathways to reduce inflammation, this combination may offer a novel mechanism or pathway that directly alters the disease process. Such innovation could potentially provide enhanced efficacy or faster relief, giving hope to patients who haven't found success with existing therapies. By targeting different aspects of the condition, APG777 and APG990 could change the way we manage atopic dermatitis.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Research has shown that APG777 and APG990 may help treat moderate-to-severe atopic dermatitis (AD). In this trial, participants will receive a combination of these two treatments. A recent study demonstrated that APG777 achieved its main goals after 16 weeks, proving it can reduce symptoms. Early results for APG990, an antibody, also surpassed expectations, suggesting it might help manage AD. These findings indicate that using APG777 and APG990 together could potentially provide relief for people with AD.15678

Are You a Good Fit for This Trial?

Adults with moderate-to-severe atopic dermatitis can join this study. Participants will be involved for about 82 weeks, including screening, treatment, and follow-up periods. Specific eligibility details are not provided.

Inclusion Criteria

My skin condition did not improve with creams or ointments.
Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1) visit
I have been diagnosed with Alzheimer's disease for over a year.
See 1 more

Exclusion Criteria

I have previously been treated with specific monoclonal antibodies.
History of known hypersensitivity to any of the ingredients in APG777, APG990, or dupilumab
I haven't used any systemic treatments, phototherapies, or laser therapy that could affect my condition in the last 4 weeks.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 6 weeks

Treatment

Participants receive the combination of APG777 + APG990 or dupilumab from Baseline to Week 24

24 weeks
Visits at Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks
Visits from Week 28 to Week 76

What Are the Treatments Tested in This Trial?

Interventions

  • APG777
  • APG990
Trial Overview The trial is testing the safety and how the body processes a combination of two drugs (APG777 + APG990) compared to an existing medication called Dupilumab in adults with moderate-to-severe atopic dermatitis.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: APG777 + APG990Experimental Treatment2 Interventions
Group II: DupilumabActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Apogee Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
390+

Citations

NCT07027527 | An Active Comparator Safety Study ...The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults ...
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 ...
Apogee Therapeutics Announces Positive Interim Phase 1 ...Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately ...
Apogee Reveals New APG777 Atopic Dermatitis Phase 2 ...Apogee's Phase 2 APEX trial of APG777 in moderate-to-severe atopic dermatitis met its primary and secondary endpoints at 16 weeks, ...
An Active Comparator Safety Study Evaluating the ...The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + ...
Apogee Therapeutics Provides Pipeline Progress and Reports ...Pipeline programs continue to advance, with four clinical data readouts anticipated in 2026; APG777 trial readout timelines accelerated, ...
Release Details - Investor Relations | Apogee Therapeutics, Inc.The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG990 and is expected to enroll approximately 40 healthy adults ...
Apogee Therapeutics' APG990 Demonstrates Extended ...APG990 showed a 60-day half-life and favorable safety, supporting potential 3-6 month maintenance dosing for atopic dermatitis.
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