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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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

Other trials in United States

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

Other trials in China

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

Other trials in Canada

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

Other trials in Japan

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

Other trials in Poland

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

Other trials in Australia

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

Other trials in Germany

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).

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 groups in NCT05995964
Study groupRoleWhat they receive
Stage 1_PF-07275315ExperimentalStage 1 PF-07275315 Injections over 12 weeks
Receives: Drug: PF-07275315
Stage 1_PF-07264660ExperimentalStage 1 PF-07264660 Injections over 12 weeks
Receives: Drug: PF-07264660
Stage 1_PlaceboExperimentalStage 1 Placebo Injections over 12 weeks
Receives: Other: Placebo
Stage 2_PF-07275315 _Dose AExperimentalStage 2 PF-07275315 Injections over 12 weeks.
Receives: Drug: PF-07275315
Stage 2_PF-07275315 _Dose BExperimentalStage 2 PF-07275315 Injections over 12 weeks.
Receives: Drug: PF-07275315
Stage 2_PF-07275315 _Dose CExperimentalStage 2 PF-07275315 Injections over 12 weeks.
Receives: Drug: PF-07275315
Stage 2_PF-07275315 _Dose DExperimentalStage 2 PF-07275315 or PF-07264660 Injections over 12 weeks.
Receives: Drug: PF-07275315; Drug: PF-07264660
Stage 2_PlaceboExperimentalStage 2 Placebo Injections over 12 weeks.
Receives: Other: Placebo
Stage 3_Placebo+PF-07275315_Dose AExperimentalStage 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 BExperimentalStage 3 PF-07275315 Injections for 32 weeks.
Receives: Drug: PF-07275315
Stage 4_PF-07264660_Dose AExperimentalStage 4 PF-07264660 Injections for 12 weeks
Receives: Drug: PF-07264660
Stage 4_PF-07264660_Dose BExperimentalStage 4 PF-07264660 Injections for 12 weeks
Receives: Drug: PF-07264660
Stage 4_PF-07264660_Dose CExperimentalStage 4 PF-07264660 Injections for 12 weeks
Receives: Drug: PF-07264660
Stage 4_PlaceboExperimentalStage 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.

  1. 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)

  1. 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.

  2. 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.

  3. 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.

  4. The number and % of participants with treatment emergent AEs

    Incidence of treatment emergent AEs

    Measured: Screening - Week 36

  5. The number and % of participants with clinically significant changes in vital signs

    Incidence of clinically significant changes in vital signs

    Measured: Screening - Week 36

  6. The number and % of participants with clinically significant changes in ECG

    Incidence of clinically significant changes in ECG

    Measured: Screening - Week 36

  7. 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.

  1. First posted16 Aug 2023
  2. Study start22 Aug 2023
  3. Primary completion12 Nov 2026 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-07275315 and PF-07264660 in people with Atopic Dermatitis, run by Pfizer at 96 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, China, Canada, Japan, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants achieving ≥75% improvement in EAS175 from baseline at week16. (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05995964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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