APG777 for Eczema

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Apogee Therapeutics, Inc.

Must not be taking: Monoclonal antibodies, others

Disqualifiers: Prior APG777 study, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.

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.

Research Team

Eligibility Criteria

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

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.

Trial Timeline

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

Treatment Details

Interventions

• APG777 (Monoclonal Antibodies)

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.

Participant Groups

Group I: Part B: Maintenance Period: APG777 Experimental Treatment 1 Intervention

Participants will receive APG777 per protocol defined dosing regimen

Group II: Part B: Induction Period: APG777 Experimental Treatment 1 Intervention

Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen

Group III: Part A: Maintenance Period: APG777 Experimental Treatment 1 Intervention

Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen

Group IV: Part A: Induction Period: APG777 Experimental Treatment 1 Intervention

Participants will receive APG777 per protocol defined dosing regimen

Group V: Part B: Induction Period: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo injections per protocol defined dosing regimen

Group VI: Part A: Induction Period: Placebo Placebo Group 1 Intervention

Participants will receive matching Placebo injections per protocol defined dosing regimen

Who Is Running the Clinical Trial?

Apogee Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

390+