A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: PF-07275315; Drug: PF-07264660; Other: Placebo

• Registration Number: NCT05995964
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD). AD is a long- lasting itchy red rash, caused by a skin reaction.

This study is seeking participants who:

* are 18 years of age or more.

* Were confirmed to have AD at least 6 months ago.

* Are not having an effective treatment result from medicines that are applied on skin for AD.

* Are considered by their doctors to have moderate to severe AD.

In Stage 1 of the study, participants will receive either PF-07275315 or PF-07264660 or placebo. Stage 1 is complete. In Stage 2 of the study participants will receive either PF-07275315 or placebo. In Stage 3 of the study participants who have received anti-inflammatory proteins, will receive either PF-07275315 or placebo. A placebo does not have any medicine in it but looks just like the medicines being studied.

PF-07275315 or PF-07264660 or placebo will be given as multiple shots in the clinic over the course of 12 weeks.

Stage 1 participants will receive shots at the study clinic on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Stage 2 participants will receive shots at the study clinic on Day 1, Week 4, Week 8 and Week 12.

Stage 3 participants will receive shots at the study clinic on Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28.

The experiences of people receiving PF-07275315 or PF-07264660 will be compared to people who do not. This will help determine if PF-07275315 and PF-07264660 are safe and effective.

Participants in Stage 1 and 2 will be involved in this study for up to 40 weeks (10 months). During this time, Stage 1 participants will have 13 visits at the study clinic, and Stage 2 participants will have 9 visits at the study clinic. Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months); and will have 13 visits at the study clinic.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-10
• Study First Posted: 2023-08-16
• Study Start: 2023-08-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2026-06-27
• Study Completion: 2026-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Must meet the following AD criteria:

1. Participants aged 18 years or older

2. Clinical diagnosis of chronic atopic dermatitis:

   1. for at least 6 months prior to Day 1 with diagnosis confirmed by photograph;
   2. Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutive weeks within 6 to 12 months of the first dose of the study intervention; OR documented reason why topical treatments are considered medically inappropriate;
   3. Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits).
   4. Bio-experienced cohort-partial or non-responder to anti-inflammatory proteins, intolerance or AEs to anti-inflammatory proteins or loss of access to anti-inflammatory proteins.

   Other Inclusion Criteria:

3. BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).

4. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria

• Medical Conditions:

1. Significant allergic or autoimmune diseases, other than AD and well controlled mild to moderate including but not limited to: SLE or other complement disorders; Type 1 diabetes; IBD; Multiple Sclerosis.

2. History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, including hypersensitivity to PF-07275315 or PF-07264660 or to the excipients of the formulated drug products. Participants with significant reactions to single, identified, avoidable allergens (eg, peanut allergy) may be eligible if avoidance of these allergens during the study is feasible.

3. Any of the following acute or chronic infections or infection history:

   1. Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening;
   2. Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
   3. Active chronic or acute skin infection requiring treatment with systemic [(not IV)] antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections (requiring no more than topical anti-infective treatments) within 1 week prior to Day 1.
   4. Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;

4. History of or current evidence of inflammatory skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that could interfere with evaluation of AD or response to treatment.

5. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

   • Prior/Concomitant Therapy:

6. Current use of any prohibited concomitant medication(s).

7. Phototherapy narrowband UVB (NB UVB) or broadband phototherapy or regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks prior to Day 1.

   • Prior/Concurrent Clinical Study Experience:

8. Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).

9. HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.

10. Evidence of active or latent TB, or inadequately treated infection with Mycobacterium TB. A participant who is currently being treated for active or latent TB infection must be excluded from this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1_PF-07275315	PF-07275315	Stage 1 PF-07275315 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
Stage 1_PF-07264660	PF-07264660	Stage 1 PF-07264660 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
Stage 1_Placebo	Placebo	Stage 1 Placebo Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
Stage 2_PF-07275315 _Dose A	PF-07275315	Stage 2 PF-07275315 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2_PF-07275315 _Dose B	PF-07275315	Stage 2 PF-07275315 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2_PF-07275315 _Dose C	PF-07275315	Stage 2 PF-07275315 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2_PF-07275315 _Dose D	PF-07275315	Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2_PF-07275315 _Dose D	PF-07264660	Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2_Placebo	Placebo	Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 3_Placebo+PF-07275315_Dose A	PF-07275315	Stage 3 Placebo for 16 weeks followed by PF-07275315 400 mg load + 200 mg Q4W for 16 weeks.
Stage 3_Placebo+PF-07275315_Dose A	Placebo	Stage 3 Placebo for 16 weeks followed by PF-07275315 400 mg load + 200 mg Q4W for 16 weeks.
Stage 3_PF-07275315_Dose B	PF-07275315	Stage 3 PF-07275315 800 mg load + 400 mg Q4W for 32 weeks.

Primary Outcome Measures

Name	Time	Method
The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.	Week 16	EASI75 (≥75% improvement from baseline) at Week 16

Secondary Outcome Measures

Name	Time	Method
The number and % of participants with clinically significant changes in laboratory tests	Screening - Week 36	Incidence of clinically significant changes in laboratory tests
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	Screening through study completion, an average of 36 weeks.	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
The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16	All scheduled timepoints other than Week 16, screening through study completion, an average of 36 weeks.	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	Screening through study completion, an average of 36 weeks.	Percent change from baseline in EASI total score at scheduled time points
The number and % of participants with treatment emergent AEs	Screening - Week 36	Incidence of treatment emergent AEs
The number and % of participants with clinically significant changes in vital signs	Screening - Week 36	Incidence of clinically significant changes in vital signs
The number and % of participants with clinically significant changes in ECG	Screening - Week 36	Incidence of clinically significant changes in ECG

Trial Locations

Locations (96)

Allervie Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Onyx Clinical Research - Peoria; 🇺🇸 Peoria, Arizona, United States

Medical Dermatology Specialists; 🇺🇸 Phoenix, Arizona, United States

Onyx Clinical Research; 🇺🇸 Phoenix, Arizona, United States

Banner - University Medicine Dermatology Clinic; 🇺🇸 Tucson, Arizona, United States

Marvel Clinical Research; 🇺🇸 Huntington Beach, California, United States

California Allergy and Asthma Medical Group; 🇺🇸 Los Angeles, California, United States

University Dermatology Trials, INC.; 🇺🇸 Newport Beach, California, United States

Northridge Clinical Trials; 🇺🇸 Northridge, California, United States

Profound Research LLC; 🇺🇸 Oceanside, California, United States

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