← Back to Search

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 76 weeks.

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of two drugs to treat long-lasting itchy red skin rash caused by skin reaction. Participants will receive shots in the clinic over 12 weeks.

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.Check my eligibility

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.See study design

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 76 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all scheduled timepoints other than week 16, screening through study completion, an average of 76 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 76 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,662 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,091,880 Total Patients Enrolled

Media Library

PF-07264660 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05995964 — Phase 2

Atopic Dermatitis Research Study Groups: Stage 1_Placebo, Stage 2_PF-07275315 or PF-07264660_Dose A, Stage 2_PF-07275315 or PF-07264660_Dose D, Stage 2_PF-07275315 or PF-07264660_Dose B, Stage 2_PF-07275315 or PF-07264660_Dose C, Stage 2_Placebo, Stage 1_PF-07275315, Stage 1_PF-07264660

Atopic Dermatitis Clinical Trial 2023: PF-07264660 Highlights & Side Effects. Trial Name: NCT05995964 — Phase 2

PF-07264660 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05995964 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How perilous is Stage 1_PF-07275315 to human health?

"In terms of safety, the rating for Stage 1_PF-07275315 stands at a 2 as there is some evidence for its security but no information regarding efficacy."

Answered by AI

Is there an opportunity for individuals to participate in this clinical investigation?

"Data found on clinicaltrials.gov reveals that this particular medical trial is not presently seeking participants, even though it was first posted on August 22nd 2023 and last updated a few weeks later. Nonetheless, there are 233 other trials actively recruiting patients at the moment."

Answered by AI