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Atopic DermatitisPhase 2NCT07216027

A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema

A Phase 2 study testing PF-08049820 in people with Atopic Dermatitis and Eczema, Atopic, run by Pfizer at 42 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin. The study is seeking participants who: 1. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Atopic Dermatitis, Eczema, Atopic
What is being tested?
PF-08049820
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
42 sitesin 8 countries
Study dates
20 Nov 2025to 2 Feb 2028
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 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants must meet the following criteria:
  • Are 18 to 64 years of age
  • Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
  • Have moderate to severe AD as defined by the following at screening and baseline visits:
  • Affected body surface area (BSA) greater than or equal to 10% and up to 60%;
  • Validated Investigator's Global Assessment (vIGA) greater than or equal to 3;
Show all 11Show fewer
  • Eczema Area and Severity Index (EASI) greater than or equal to 16;
  • AND
  • -Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit
  • Do not have a suitable prescribed medicine for AD.
  • Body Mass Index (BMI) of 18 to 38 kg/m2 and a total body weight greater than 48 kg (106 lbs)

Who cannot join

  • Participants must not meet the following criteria:
  • Have an infection that requires treatment
  • Have other skin conditions other than AD
  • Have severe uncontrolled asthma
  • Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit

Trial locations and contacts

42 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

42 sites in 8 countries

United States17 sites, 16 recruiting

  • Marvel Clinical Research

    Huntington Beach, California, 92647

    Recruiting

  • Metropolis Dermatology - DTLA

    Los Angeles, California, 90017

    Not yet recruiting

  • Gsi Clinical Research

    Margate, Florida, 33063

    Recruiting

  • Apex Clinical Research Center, LLC.

    Mayfield Heights, Ohio, 44124

    Not yet recruiting

  • Skin Research of South Florida

    Miami, Florida, 33173

    Active, not recruiting

  • Northridge Clinical Trials

    Northridge, California, 91325

    Recruiting

  • Paddington Testing Co, Inc

    Philadelphia, Pennsylvania, 19103

    Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

    Recruiting

  • Mayo Clinic Specialty Building

    Phoenix, Arizona, 85054

    Recruiting

  • UPMC Department of Dermatology

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • Clinical Science Institute

    Santa Monica, California, 90403

    Recruiting

  • Mayo Clinic

    Scottsdale, Arizona, 85259

    Recruiting

  • Montefiore - Jacobi Dermatology Clinic

    The Bronx, New York, 10461

    Recruiting

  • Montefiore - Clinical Research Center

    The Bronx, New York, 10467

    Recruiting

  • Montefiore - Greene Medical Arts Pavillion

    The Bronx, New York, 10467

    Recruiting

  • Montefiore - The Dermatology Center

    The Bronx, New York, 10467

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

Other trials in United States

Japan6 sites, 6 recruiting

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo, 103-0025

    Recruiting

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

    Recruiting

  • Kosugi Dermatology Clinic

    Kawasaki-shi, Kanagawa, 211-0063

    Recruiting

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324

    Recruiting

  • Hattori Dermatology Clinic

    Takasaki, Gunma, 370-0071

    Recruiting

  • Queen's square Medical Facilities Queen's square Dermatology and Allergology

    Yokohama, Kanagawa, 220-6208

    Recruiting

Other trials in Japan

Poland5 sites, 5 recruiting

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

    Not yet recruiting

  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

    Krakow, Lesser Poland Voivodeship, 30-348

    Not yet recruiting

  • Centrum Nowoczesnych Terapii Dobry Lekarz spółka z ograniczoną odpowiedzialnością

    Krakow, 31-011

    Not yet recruiting

  • Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki

    Szczecin, West Pomeranian Voivodeship, 70-332

    Not yet recruiting

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-500

    Not yet recruiting

Other trials in Poland

China4 sites, 4 recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350008

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Recruiting

Other trials in China

Czechia4 sites, 4 recruiting

  • DERMAMEDICA s.r.o.

    Náchod, 547 01

    Not yet recruiting

  • CCR Ostrava, s.r.o.

    Ostrava, 702 00

    Recruiting

  • Pratia Czech s.r.o.

    Pardubice, 530 02

    Recruiting

  • Pratia Czech s.r.o.

    Prague, 130 00

    Not yet recruiting

Other trials in Czechia

France3 sites, 3 recruiting

  • Hopital Saint Louis

    Paris, 75010

    Not yet recruiting

  • Hopital Charles Nicolle

    Rouen, 76031

    Recruiting

  • Hopital Larrey

    Toulouse, 31059

    Not yet recruiting

Other trials in France

Canada2 sites, 2 recruiting

  • Centre de Recherche Saint-Louis inc.

    Québec, G1W 4R4

    Recruiting

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8

    Not yet recruiting

Other trials in Canada

Bulgaria1 site, 1 recruiting

  • ASMC - IPSMC - skin and venereal diseases

    Sofia, Sofia (stolitsa), 1407

    Not yet recruiting

Other trials in Bulgaria

About this study

Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.

The study is seeking participants who:

Read more
  1. Are 18 to 64 years of age;
  2. Were confirmed to have AD at least 6 months ago;
  3. Do not have a suitable prescribed medicine for AD;
  4. Are considered by their doctors to have moderate to severe AD.

The study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.

Being tested
PF-08049820, Placebo
Keywords
Eczema, Atopic Dermatitis
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-08049820Drug

    Tablet

  • PlaceboDrug

    Tablet

Study groups in NCT07216027
Study groupRoleWhat they receive
Arm 2ExperimentalStages 1 and 2: Tablets taken by mouth daily for 12 weeks
Receives: Drug: PF-08049820
Arm 3ExperimentalStages 1 and 2: Tablets taken by mouth daily for 12 weeks
Receives: Drug: PF-08049820
Arm 1ExperimentalStages 1 and 2: Tablets taken by mouth daily for 12 weeks
Receives: Drug: PF-08049820
Arm 4Placebo comparatorStages 1 and 2: Tablets taken by mouth daily for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12

    Measured: Week 12

Secondary outcomes (6)

  1. Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points

    Measured: Day 1 through Week 16

  2. Percent change from baseline in EASI total score at scheduled time points other than Week 12

    Measured: Day 1 through Week 16

  3. Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >2 points at scheduled time points

    Measured: Day 1 through Week 16

  4. Response based on achieving ≥4 points of reduction from baseline in weekly averages of Peak Pruritus-Numerical Rating Scale (PP-NRS4) at scheduled time points

    Measured: Day 1 through Week 16

  5. Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs), and clinically significant changes in laboratory tests, vital signs and ECGs

    Measured: Day 1 through Week 16

  6. Change from baseline in biomarker at scheduled time points

    Measured: Day 1 through Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2025
  2. Study start20 Nov 2025
  3. Primary completion2 Feb 2028 (estimated)
  4. Study completion2 Feb 2028 (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
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07216027
Sponsor's protocol ID
C6231002
Other IDs
2025-522965-31-00, 2025
Status last verified
Oct 2026
First submitted
9 Oct 2025
Last updated
13 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-08049820 in people with Atopic Dermatitis and Eczema, Atopic, run by Pfizer at 42 sites in 8 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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 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 42 sites in United States, Japan, Poland, China, Czechia and 3 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. Some participants in this study may receive a placebo. 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?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12 (time frame: Week 12). 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 NCT07216027.

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 13 Oct 2026.

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Clinical Trial NCT07216027 | AzTrials