What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly systemic treatments similar to PF-07275315 and PF-07264660, include monoclonal antibodies like dupilumab, JAK inhibitors, and anti-IL-31 antibodies. Known side effects of these treatments can include injection site reactions, nasopharyngitis, headache, and an increased risk of infections. Dupilumab specifically has been associated with conjunctivitis and facial redness. JAK inhibitors may cause nasopharyngitis and headache, while anti-IL-31 antibodies like nemolizumab can lead to mild adverse events such as exacerbation of atopic dermatitis. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several systemic treatments for moderate-to-severe atopic dermatitis. Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, was one of the first biologics approved for this condition. Other similar treatments include tralokinumab, which also targets IL-13, and abrocitinib, a Janus kinase (JAK) inhibitor. These treatments have shown efficacy in reducing the symptoms of atopic dermatitis and are administered either via injection or orally, similar to the investigational drugs PF-07275315 and PF-07264660.

What other types of research exist?

Promising, novel alternatives for atopic dermatitis treatment in 2024 include: 1) Crisaborole ointment, a non-steroidal phosphodiesterase 4 inhibitor, which has shown safety and efficacy in clinical trials for mild to moderate AD. 2) E6005, another topical phosphodiesterase 4 inhibitor, which has demonstrated positive results in both children and adults with AD. These alternatives offer new mechanisms of action and have been evaluated in recent clinical studies, making them potential options for AD patients.

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Monoclonal Antibodies

PF-07275315 + PF-07264660 for Eczema

Phase 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all scheduled timepoints other than week 16, screening through study completion, an average of 36 weeks.

Summary

This trial is testing two new medicines, PF-07275315 and PF-07264660, given as shots to adults with moderate to severe atopic dermatitis that hasn't improved with other treatments. The goal is to see if these medicines are safe and effective in reducing the symptoms of this itchy red rash.

Who is the study for?

Adults over 18 with moderate to severe atopic dermatitis (AD), diagnosed at least 6 months ago, who haven't responded well to topical treatments or for whom these are not suitable. Participants must have a BMI of 17.5-40 and weigh over 45 kg. Exclusions include significant allergies or autoimmune diseases, recent serious infections, other skin conditions that could affect AD assessment, psychiatric risks, prohibited medication use, recent phototherapy or investigational drug use.

What is being tested?

The trial is testing two potential medications for AD: PF-07275315 and PF-07264660 against a placebo. These are administered as injections in the clinic across different schedules in Stage 1 and Stage 2 of the study. The trial aims to determine their safety and effectiveness by comparing outcomes between those receiving the drugs and those on placebo over up to an approximately 20-month period.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with clinical trials for new AD medications may include reactions at injection sites such as redness or pain, possible allergic reactions due to protein content in therapeutics, fatigue, headaches, gastrointestinal issues like nausea or diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all scheduled timepoints other than week 16, screening through study completion, an average of 36 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all scheduled timepoints other than week 16, screening through study completion, an average of 36 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all scheduled timepoints other than week 16, screening through study completion, an average of 36 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.

Secondary study objectives

The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16

The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points

The number and % of participants achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points

+4 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Stage 2_PlaceboExperimental Treatment1 Intervention

Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.

Group II: Stage 2_PF-07275315 or PF-07264660_Dose DExperimental Treatment2 Interventions

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Group III: Stage 2_PF-07275315 or PF-07264660_Dose CExperimental Treatment2 Interventions

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Group IV: Stage 2_PF-07275315 or PF-07264660_Dose BExperimental Treatment2 Interventions

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Group V: Stage 2_PF-07275315 or PF-07264660_Dose AExperimental Treatment2 Interventions

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Group VI: Stage 1_PlaceboExperimental Treatment1 Intervention

Stage 1 Placebo Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Group VII: Stage 1_PF-07275315Experimental Treatment1 Intervention

Stage 1 PF-07275315 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Group VIII: Stage 1_PF-07264660Experimental Treatment1 Intervention

Stage 1 PF-07264660 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-07275315

2022

Completed Phase 1

~70

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atopic Dermatitis (AD) include topical corticosteroids, which reduce inflammation and immune responses in the skin, and calcineurin inhibitors like tacrolimus and pimecrolimus, which inhibit T-cell activation and cytokine release. Phosphodiesterase 4 (PDE4) inhibitors, such as crisaborole, work by reducing the production of inflammatory cytokines. Biologics, like dupilumab, target specific pathways in the immune system, such as the interleukin-4 and interleukin-13 pathways, to reduce inflammation and itch. These mechanisms are crucial for AD patients as they directly address the underlying inflammation and immune dysregulation that cause the symptoms of AD. The investigational drugs PF-07275315 and PF-07264660 are likely designed to target similar inflammatory pathways, aiming to provide effective and safe treatment options for those with moderate to severe AD.

Emerging Treatment Options in Atopic Dermatitis: Topical Therapies.Safety and efficacy of topical E6005, a phosphodiesterase 4 inhibitor, in Japanese adult patients with atopic dermatitis: results of a randomized, vehicle-controlled, multicenter clinical trial.