A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
Recruiting · NCT05995964 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
PF-07264660PF-07275315Placebo
What this trial is about
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. In Stage 4 of the study participants will receive either 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 each Stage. 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 Stages 1, 2 and 4 will be involved in this study for up to 40 weeks (10 months). Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Must meet the following AD criteria:
- Participants aged 18 years or older
- Clinical diagnosis of chronic atopic dermatitis:
- for at least 6 months prior to Day 1 with diagnosis confirmed by photograph;
- 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;
- Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits).
- Bio-experienced cohort-partial or non-responder to anti-inflammatory proteins (also known as biologics), intolerance or AEs to anti-inflammatory proteins or loss of access to anti-inflammatory proteins with ≥12 weeks of treatment within 5 years.
- ther Inclusion Criteria:
- BMI of 17.5 to 40 kg/m2; and a total body weight \>45 kg (100 lbs).
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.
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; IBD; Multiple Sclerosis.
- 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.
- Any of the following acute or chronic infections or infection history:
- Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening;
- Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
- 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.
- 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 could 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.
Where it is running
60 locations listed across 19 US states.
- 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
- Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. - San Diego, California, United States
- West Dermatology La Jolla - San Diego, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- AboutSkin Research, LLC - Greenwood Village, Colorado, United States
- Renaissance Research and Medical Group - Cape Coral, Florida, United States
- Florida International Medical Research - Coral Gables, Florida, United States
- Revival Research - Doral, Florida, United States
- St. Jude Clinical Research - Doral, Florida, United States
- SouthCoast Research Center - Miami, Florida, United States
- Floridian Research Institute Llc - Miami, Florida, United States
- Global Health Research Center, Inc. - Miami Lakes, Florida, United States
- Ziaderm Research LLC - North Miami Beach, Florida, United States
- Clinical Neuroscience Solutions, Inc. - Orlando, Florida, United States
- GCP Research, Global Clinical professionals - St. Petersburg, Florida, United States
- ForCare Clinical Research - Tampa, Florida, United States
- Dawes Fretzin Clinical Research Group, LLC - Indianapolis, Indiana, United States
- Southern Indiana Clinical Trials - New Albany, Indiana, United States
- Maryland Laser Skin and Vein - Hunt Valley, Maryland, United States
- Michigan Center for Research Company - Clarkston, Michigan, United States
- MI Skin Innovations - Northville, Michigan, United States
- Revival Research Institute LLC - Troy, Michigan, United States
- Skin Specialists, PC dba Schlessinger MD - Omaha, Nebraska, United States
- Empire Dermatology - East Syracuse, New York, United States
- Private Practice - Dr. Bobby Buka - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Sadick Research Group - New York, New York, United States
- Apex Clinical Research Center - Mayfield Heights, Ohio, United States
- Epic Medical Research - Oklahoma - Chickasha, Oklahoma, United States
- Unity Clinical Research - Oklahoma City, Oklahoma, United States
- Vital Prospects Clinical Research Institute, PC - Tulsa, Oklahoma, United States
- Velocity Clinical Research, Medford - Medford, Oregon, United States
- Paddington Testing Co, Inc - Philadelphia, Pennsylvania, United States
- Clinical Partners, LLC - Johnston, Rhode Island, United States
- National Allergy and Asthma - North Charleston, South Carolina, United States
- Spartanburg Medical Research - Spartanburg, South Carolina, United States
- Clinical Neuroscience Solutions Inc. - Memphis, Tennessee, United States
- Dermatology Treatment and Research Center - Dallas, Texas, United States
- North Texas Center for Clinical Research - Frisco, Texas, United States
- Alpesh D. Desai, DO PLLC - Houston, Texas, United States
- DCT-Stone Oak, LLC dba Discovery Clinical Trials - San Antonio, Texas, United States
- Complete Dermatology - Sugar Land, Texas, United States
- Virginia Dermatology and Skin Cancer Center - Norfolk, Virginia, United States
- Synexus Polska Sp. z o.o. Oddzial w Katowicach - Katowice, Poland
- Centre de Recherche Saint-Louis inc. - Québec, Canada
- Shanghai First People's Hospital - Shanghai, China
- Beijing Friendship Hospital Affiliate of Capital University - Beijing, Beijing Municipality, China
- The First Affiliated Hospital Of Fujian Medical University - Fuzhou, Fujian, China
- Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica" - Poznan, Greater Poland Voivodeship, Poland
- Dongguan People's Hospital - Dongguan, Guangdong, China
- Guangdong Province Dermatology Hospital - Guangzhou, Guangdong, China
Showing 60 of 98 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →