PF-08049820 for Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- Participants ≥18 years of age (or the minimum age of consent in accordance with local regulations) at screening.  Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.  Although no effects on reproduction were noted in rat and rabbit dose-rangefinding EFD studies, enrollment of IOCBP will be limited to 150 participants in the study until all the GLP EFD toxicity studies are completed and demonstrate that there are no adverse effects on the reproduction.  Individuals on HRT and whose menopausal status is in doubt will be required to use 1 of the highly effective non-estrogen hormonal contraception methods if they wish to continue their HRT during the trial. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before trial enrollment (Section 10.4.3).\n- Must meet the following AD criteria: a. Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs (at screening) and medical record (if available) (according to Hanifin and Rajka criteria of AD). b. 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 A documented reason why topical treatments are considered medically inappropriate (eg, because of important side effects or safety risks) within the last year. c. Naïve to anti-inflammatory protein therapeutics and/or JAK inhibitors or have responded to prior anti-inflammatory protein therapeutics and/or JAK inhibitors but lost access (e.g. insurance changes) or had intolerance/AEs. Participants who have had inadequate response to anti-inflammatory protein therapeutics and/or JAK inhibitors are ineligible. d. Moderate to severe AD at both the screening and baseline visits as defined by the following: i. BSA ≥10% and up to 60% (15% cap will be placed on the number of participants with BSA ≥41% to 60%); ii. vIGA ≥3; iii. EASI ≥16; AND iv. PP-NRS ≥4 at screening and weekly average PP-NRS of ≥4 at baseline from 7 days to 1 day prior to randomization. Four or more daily PPNRS entries are needed to calculate the weekly average.\n- BMI of 17.5 to 40 kg/m² and a total body weight >45 kg (100 lbs).\n- Willing and able to comply with all scheduled visits, treatment plan and study procedures."}

Exclusion criteria

• {"criterion_text":"- Presence of skin comorbidities that would interfere with study assessment or response to treatment.\n- Undergone significant trauma or surgery within 1 month prior to screening.\n- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. a. At screening visit, if there are “yes” answers on items 4 or 5 in the past year or on any question in the suicidal behavior section of the C-SSRS in the past 5 years, the participant will not be included in the study. b. At screening visit, if the PHQ-8 total score is ≥15 at screening the participant will be excluded from the study. c. At Day 1 visit, if there are “yes” answers on items 4, 5 of the suicidal ideation subscale or on any behavioral question of the Since Last Visit C‑SSRS, the participant will not be dosed and will be discontinued from the study.\n- Use of any prohibited concomitant medication(s). Refer to Section 6.9 and Appendix 9.\n- Regular use (more than 2 visits per week) of a tanning booth/parlor or phototherapy for AD within 4 weeks of the screening visit.\n- Treatment with a live (attenuated) vaccine within 12 weeks of Day 1 visit or planned during the study.\n- Inadequate response to anti-inflammatory protein therapeutics and/or JAK inhibitors.\n- Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.\n- Renal impairment as defined by eGFR <60 mL/min/1.73 m², which may be confirmed by a single repeat test, if necessary.\n- Hepatic dysfunction defined as having any 1 of the following, which may be confirmed by a single repeat test, if necessary:  Total bilirubin ≥1.5 × ULN (For Gilbert’s syndrome, direct bilirubin > ULN is exclusionary  AST ≥2.0 × ULN  ALT ≥2.0 × ULN\n- Hematologic abnormalities defined as any 1 of the following, which may be confirmed by a single repeat test, if necessary:  ANC ≤1,500/mm3  Platelets ≤120,000/mm3  Hemoglobin: ≤13 g/dL for males; ≤12 g/dL for females\n- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day 1 visit or superficial skin infections within 1 week before Day 1 visit. Note: participants may be rescreened after infection resolves.\n- Baseline standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (including, but not limited to, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST segment and/or T wave changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant’s eligibility. Computer-interpreted ECGs should be overread by an investigator experienced in reading ECGs before excluding a participant.\n- Have current or a history of alcohol abuse or binge drinking and/or any other illicit drug use or dependence in the past 2 years which, in the opinion of the investigator, could create a risk for the participant’s health or protocol adherence. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).\n- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.\n- Hypersensitivity to PF-08049820 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. Participants with such a history need to have and know how to use an epinephrine injection (eg, EpiPen).\n- A history (within approximately 3 months prior to Day 1) of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy (within approximately 2 weeks prior to Day 1), or as otherwise judged clinically significant by the investigator.\n- Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg, comorbid severe uncontrolled asthma or a history ≥2 asthma exacerbations within the last 12 months requiring systemic (oral and/or parenteral) corticosteroid treatment or hospitalization for >24 hours. a. Participants with well controlled mild to moderate asthma (ie, not requiring high dose inhaled corticosteroids, systemic [oral or parenteral] corticosteroids, or biologic asthma treatment, and having FEV1 ≥ 70% predicted) are eligible.\n- Current or recent history (within approximately 3 months prior to Day 1) of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.\n- Currently on any suppressive therapy for a chronic infection (such as pneumocystis, CMV, and atypical mycobacteria) that, in the opinion of the investigator and sponsor, would place the participant at risk for reactivation. Participants receiving prophylactic therapy for prior outbreaks of herpes simplex virus or herpes zoster may be enrolled with the expectation that this treatment will continue for the duration of the study.\n- A history of cancer within 5 years or has undergone treatment for any type of cancer at the time of screening, with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.\n- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, Hepatitis B or C. Refer to Section 8.3.5, Section 8.3.6, and Appendix 2.\n- Evidence of active or latent TB, or history of inadequately treated infection with Mycobacterium TB. See Section 8.3.7 and Appendix 2."}

Primary endpoints

• {"endpoint_text":"- Percent change from baseline in EASI total score at Week 12","definition_or_measurement_approach":"Percent change from baseline in the Eczema Area and Severity Index (EASI) total score measured at Week 12."}

Secondary endpoints

• {"endpoint_text":"- Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points","definition_or_measurement_approach":"Proportion of participants achieving ≥75% improvement from baseline in EASI (EASI75) at scheduled time points."}
• {"endpoint_text":"- Percent change from baseline in EASI total score at scheduled time points other than Week 12","definition_or_measurement_approach":"Percent change from baseline in EASI total score measured at scheduled time points other than Week 12."}
• {"endpoint_text":"- Response based on achieving 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","definition_or_measurement_approach":"Proportion of participants achieving vIGA 0 or 1 with ≥2-point reduction from baseline on the validated Investigator Global Assessment at scheduled time points."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of participants achieving a ≥4-point reduction from baseline in weekly average PP-NRS (peak pruritus NRS) at scheduled time points; weekly average calculated from daily entries (≥4 daily entries required)."}
• {"endpoint_text":"- Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs), and clinically significant changes in laboratory tests, vital signs, and electrocardiograms (ECGs)","definition_or_measurement_approach":"Incidence and nature of treatment-emergent AEs and SAEs and clinically significant changes in labs, vital signs and ECGs collected during the study."}

Methods

• Participant Database Letter (documents present for multiple countries: BG, CZ, PL) - site-to-patient database outreach as indicated by 'Participant Database Letter' files.
• Patient Flyer / Patient Flyer (country-specific) and Patient Poster / Patient Brochure (BG, CZ, FR, DE, PL) - printed/digital materials for patient outreach listed in recruitment documents.
• Call Scripts and Referral Confirmation Email (DE, PL) - telephone outreach and email follow-up materials indicated.
• Global Participant Website Layout - presence of a global participant website layout file indicates planned website-based recruitment/participant information.
• Prescreener and Participant Media Board (PL) - prescreening materials and site media boards indicated by filenames.

Bulgaria

Earliest CTIS Part Ii Submission Date

02-04-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

18

Number Of Sites

4

Number Of Participants

7

Czechia

Earliest CTIS Part Ii Submission Date

18-03-2026

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

27

Number Of Sites

4

Number Of Participants

16

France

Earliest CTIS Part Ii Submission Date

16-02-2026

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

59

Number Of Sites

4

Number Of Participants

5

Germany

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

25

Number Of Sites

4

Number Of Participants

6

Poland

Earliest CTIS Part Ii Submission Date

27-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

24

Number Of Sites

7

Number Of Participants

15

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

Sponsor duty code: 4

Name

Premier Research International LLC

Responsibilities

Dictionary Coding (code 15) and sponsor duty code: 6

Third parties

• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Medical imaging - Central Reader/Reading Service","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Sponsor duty code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"Sponsor duty code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Sponsor duty code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Sponsor duty code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp","duties_or_roles":"Sponsor duty code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Premier Research International LLC","duties_or_roles":"Dictionary Coding (code 15) and sponsor duty code: 6","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Sponsor duty code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"Sponsor duty code: 7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sponsor duty code: 4","organisation_type":"Pharmaceutical company"}