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

Study Overview
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Brief Summary
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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. All participants in the study will receive either PF-07275315 or PF-07264660 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. 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 will be involved in this study for up to 80 weeks (20 months). During this time, Stage 1 participants will have 16 visits at the study clinic, and Stage 2 participants will have 12 visits at the study clinic.

Official Title
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A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 AND PF-07264660 IN ADULT PARTICIPANTS WITH MODERATE-SEVERE ATOPIC DERMATITIS

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: PF-07275315
* Drug: PF-07264660
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must meet the following AD criteria: Clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to Day 1; Either an inadequate response to treatment with topical medications (for at least 4 consecutive weeks within 1 year of the first dose of the study intervention); OR documented reason why topical treatments are considered medically inappropriate; Moderate to severe AD (defined as having an affected BSA (captured as part of EASI) ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits). Other Inclusion Criteria: BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs). Exclusion Criteria: - Medical Conditions: 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; Irritable bowel syndrome; Multiple Sclerosis. History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, except to single, identified, avoidable allergens (eg, peanut allergy). Any of the following acute or chronic infections or infection history: Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to the screening; Infection requiring hospitalization or systemic (eg, parenteral, oral) antimicrobial therapy within 60 days prior to Day 1; Active chronic or acute skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections within 1 week prior to Day 1. Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1; History of or current evidence of inflammatory skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment. 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: Current use of any prohibited concomitant medication(s). 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: 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). HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1_PF-07275315<br>Stage 1 PF-07275315 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. | Drug: PF-07275315<br>* subcutaneous injection<br>|
| Experimental: Stage 1_PF-07264660<br>Stage 1 PF-07264660 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. | Drug: PF-07264660<br>* subcutaneous injection<br>|
| Experimental: Stage 1_Placebo<br>Stage 1 Placebo Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. | Other: Placebo<br>* subcutaneous injection<br>|
| Experimental: Stage 2_PF-07275315 or PF-07264660_Dose A<br>Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. | Drug: PF-07275315<br>* subcutaneous injection<br>Drug: PF-07264660<br>* subcutaneous injection<br>|
| Experimental: Stage 2_PF-07275315 or PF-07264660_Dose B<br>Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. | Drug: PF-07275315<br>* subcutaneous injection<br>Drug: PF-07264660<br>* subcutaneous injection<br>|
| Experimental: Stage 2_PF-07275315 or PF-07264660_Dose C<br>Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. | Drug: PF-07275315<br>* subcutaneous injection<br>Drug: PF-07264660<br>* subcutaneous injection<br>|
| Experimental: Stage 2_PF-07275315 or PF-07264660_Dose D<br>Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. | Drug: PF-07275315<br>* subcutaneous injection<br>Drug: PF-07264660<br>* subcutaneous injection<br>|
| Experimental: Stage 2_Placebo<br>Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12. | Other: Placebo<br>* subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants achieving ≥75% improvement in EAS175 from baseline at week16. | EASI75 (≥75% improvement from baseline) at Week 16 | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 76 weeks. | 
| The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16 | 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 76 weeks. | 
| The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points | Percent change from baseline in EASI total score at scheduled time points | Screening through study completion, an average of 76 weeks. | 
| The number and % of participants with treatment emergent AEs | Incidence of treatment emergent AEs | Screening - Week 76 | 
| The number and % of participants with clinically significant changes in vital signs | Incidence of clinically significant changes in vital signs | Screening - Week 76 | 
| The number and % of participants with clinically significant changes in ECG | Incidence of clinically significant changes in ECG | Screening - Week 76 | 
| The number and % of participants with clinically significant changes in laboratory tests | Incidence of clinically significant changes in laboratory tests | Screening - Week 76 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema