A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
Atopic Dermatitis
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema
Eligibility Criteria
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%, IGA ≥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.
Sites / Locations
- Allervie Clinical Research
- Marvel Clinical ResearchRecruiting
- Sunwise Clinical Research
- Renaissance Research and Medical Group
- Florida International Medical ResearchRecruiting
- Revival ResearchRecruiting
- Global Health Research Center, Inc.
- SouthCoast Research Center
- Floridian Research Institute LlcRecruiting
- Floridian Research InstituteRecruiting
- Clinical Neuroscience Solutions, Inc.Recruiting
- Southern Indiana Clinical Trials
- Maryland Laser Skin and VeinRecruiting
- Michigan Center for Research CompanyRecruiting
- Epic Medical Research-Oklahoma
- Clinical Partners, LLC
- Clinical Neuroscience Solutions Inc.Recruiting
- North Texas Center for Clinical Research
- Complete Dermatology
- Virginia Dermatology and Skin Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Stage 1_PF-07275315
Stage 1_PF-07264660
Stage 1_Placebo
Stage 2_PF-07275315 or PF-07264660_Dose A
Stage 2_PF-07275315 or PF-07264660_Dose B
Stage 2_PF-07275315 or PF-07264660_Dose C
Stage 2_PF-07275315 or PF-07264660_Dose D
Stage 2_Placebo
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 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
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 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.