Atopic DermatitisPhase 2NCT05995964
A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
A Phase 2 study testing PF-07275315 and PF-07264660 in people with Atopic Dermatitis, run by Pfizer at 96 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- PF-07275315 and PF-07264660
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 507 participants
- Where
- 96 sitesin 7 countries
- Study dates
- 22 Aug 2023to 1 Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
- Other 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
96 sites in 7 countries.
96 sites in 7 countries
United States50 sites
Allervie Clinical Research
Birmingham, Alabama, 35209
Renaissance Research and Medical Group
Cape Coral, Florida, 33991
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, 73018
Michigan Center for Research Company
Clarkston, Michigan, 48346
Florida International Medical Research
Coral Gables, Florida, 33134
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Revival Research
Doral, Florida, 33122
St. Jude Clinical Research
Doral, Florida, 33172
Empire Dermatology
East Syracuse, New York, 13057
North Texas Center for Clinical Research
Frisco, Texas, 75034
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111
Alpesh D. Desai, DO PLLC
Houston, Texas, 77008
Maryland Laser Skin and Vein
Hunt Valley, Maryland, 21030
Marvel Clinical Research
Huntington Beach, California, 92647
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Clinical Partners, LLC
Johnston, Rhode Island, 02919
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
Velocity Clinical Research, Medford
Medford, Oregon, 97504
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119
SouthCoast Research Center
Miami, Florida, 33136
Floridian Research Institute Llc
Miami, Florida, 33179
Global Health Research Center, Inc.
Miami Lakes, Florida, 33016
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
Private Practice - Dr. Bobby Buka
New York, New York, 10012
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sadick Research Group
New York, New York, 10075
University Dermatology Trials, INC.
Newport Beach, California, 92660
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502
Ziaderm Research LLC
North Miami Beach, Florida, 33162
Northridge Clinical Trials
Northridge, California, 91325
MI Skin Innovations
Northville, Michigan, 48167
Profound Research LLC
Oceanside, California, 92056
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, 68144
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Onyx Clinical Research - Peoria
Peoria, Arizona, 85381
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103
Onyx Clinical Research
Phoenix, Arizona, 85050
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, 92121
West Dermatology La Jolla
San Diego, California, 92121
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
GCP Research, Global Clinical professionals
St. Petersburg, Florida, 33714
Complete Dermatology
Sugar Land, Texas, 77479
ForCare Clinical Research
Tampa, Florida, 33613
Revival Research Institute LLC
Troy, Michigan, 48084
Banner - University Medicine Dermatology Clinic
Tucson, Arizona, 85718
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
Sunwise Clinical Research
Walnut Creek, California, 94596
China19 sites
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, 100050
The first hospital of jilin university
Changchun, Jilin, 130021
The Second Xiangya Hospital of Central South University
Changsha, Hu'nan, 410011
Chengdu second people's hospital
Chengdu, Sichuan, 610017
Dongguan People's Hospital
Dongguan, Guangdong, 523109
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350008
Guangdong Province Dermatology Hospital
Guangzhou, Guangdong, 510091
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai First People's Hospital
Shanghai, 201620
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
The First Hospital of Wuhan
Wuhan, Hubei, 430022
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Canada8 sites
INTERMED Groupe Sante
Chicoutimi, Quebec, G7H 7Y8
Medicor Research Inc
Greater Sudbury, Ontario, P3C 1X3
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8
Lima's Excellence in Allergy and Dermatology Research
Hamilton, Ontario, L8L 3C3
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Centre de Recherche Saint-Louis inc.
Québec, Quebec, G1W 4R4
Toronto Research Centre
Toronto, Ontario, M3H 5Y8
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Japan6 sites
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, 158-0097
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825
Poland6 sites
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400
Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"
Poznan, Greater Poland Voivodeship, 60-681
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-381
Australia4 sites
Box Hill Hospital
Box Hill, Victoria, 3128
Sinclair Dermatology
East Melbourne, Victoria, 3002
Fremantle Dermatology
Fremantle, Western Australia, 6160
Australian Clinical Research Network
Sydney, New South Wales, NSW 2035
Germany3 sites
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455
Magdeburger Company for Medical Studies and Services
Magdeburg, Saxony-Anhalt, 39104
BAG Drs. Med. Quist PartG
Mainz, Rhineland-Palatinate, 55128
About this study
Official title: 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
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:
Read more
- 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).
- Conditions
- Atopic Dermatitis
- Being tested
- PF-07275315, PF-07264660, Placebo
- Keywords
- Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07275315Drug
subcutaneous injection
PF-07264660Drug
subcutaneous injection
PlaceboOther
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Stage 1_PF-07275315 | Experimental | Stage 1 PF-07275315 Injections over 12 weeks Receives: Drug: PF-07275315 |
| Stage 1_PF-07264660 | Experimental | Stage 1 PF-07264660 Injections over 12 weeks Receives: Drug: PF-07264660 |
| Stage 1_Placebo | Experimental | Stage 1 Placebo Injections over 12 weeks Receives: Other: Placebo |
| Stage 2_PF-07275315 _Dose A | Experimental | Stage 2 PF-07275315 Injections over 12 weeks. Receives: Drug: PF-07275315 |
| Stage 2_PF-07275315 _Dose B | Experimental | Stage 2 PF-07275315 Injections over 12 weeks. Receives: Drug: PF-07275315 |
| Stage 2_PF-07275315 _Dose C | Experimental | Stage 2 PF-07275315 Injections over 12 weeks. Receives: Drug: PF-07275315 |
| Stage 2_PF-07275315 _Dose D | Experimental | Stage 2 PF-07275315 or PF-07264660 Injections over 12 weeks. Receives: Drug: PF-07275315; Drug: PF-07264660 |
| Stage 2_Placebo | Experimental | Stage 2 Placebo Injections over 12 weeks. Receives: Other: Placebo |
| Stage 3_Placebo+PF-07275315_Dose A | Experimental | Stage 3 Placebo Injections for 16 weeks followed by PF-07275315 Injections for 16 weeks. Receives: Drug: PF-07275315; Other: Placebo |
| Stage 3_PF-07275315_Dose B | Experimental | Stage 3 PF-07275315 Injections for 32 weeks. Receives: Drug: PF-07275315 |
| Stage 4_PF-07264660_Dose A | Experimental | Stage 4 PF-07264660 Injections for 12 weeks Receives: Drug: PF-07264660 |
| Stage 4_PF-07264660_Dose B | Experimental | Stage 4 PF-07264660 Injections for 12 weeks Receives: Drug: PF-07264660 |
| Stage 4_PF-07264660_Dose C | Experimental | Stage 4 PF-07264660 Injections for 12 weeks Receives: Drug: PF-07264660 |
| Stage 4_Placebo | Experimental | Stage 2 Placebo Injections for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.
EASI75 (≥75% improvement from baseline) at Week 16
Measured: Week 16
Secondary outcomes (7)
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
Measured: Screening through study completion, an average of 36 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
Measured: All scheduled timepoints other than Week 16, screening through study completion, an average of 36 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
Measured: Screening through study completion, an average of 36 weeks.
The number and % of participants with treatment emergent AEs
Incidence of treatment emergent AEs
Measured: Screening - Week 36
The number and % of participants with clinically significant changes in vital signs
Incidence of clinically significant changes in vital signs
Measured: Screening - Week 36
The number and % of participants with clinically significant changes in ECG
Incidence of clinically significant changes in ECG
Measured: Screening - Week 36
The number and % of participants with clinically significant changes in laboratory tests
Incidence of clinically significant changes in laboratory tests
Measured: Screening - Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start22 Aug 2023
- Primary completion12 Nov 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995964
- Sponsor's protocol ID
- C4531002
- Other IDs
- 2023-505218-68-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.