Protein - Other for Moderate-severe atopic dermatitis | Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- \"1.\tParticipants aged 18 years or older.\"\n- 2. Must meet the following AD criteria a. Clinical diagnosis of chronic atopic dermatitis for approximately 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs (at screening) and medical record (if available) (Hanifin and Rajka criteria of AD). b. Either inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) consistent with AD treatment guidelines (eg, the ‘Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children’) for at least 4 consecutive weeks within 6 to 12 months (depending on time since initial diagnosis) of the first dose of the study intervention to ensure that treatment with systemic immunosuppressant therapy is appropriate or have a documented reason why such treatments are considered medically inappropriate. c. Moderate to severe AD (defined as having an affected body surface area [BSA] ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits). d. Stage 3 (bio-experienced) ONLY: Participants in Stage 3 must meet one of the following criteria associated with approved anti-inflammatory protein therapeutics (also known as “biologics”) to treat AD. i. Partial responders or non-responders to anti-inflammatory protein therapeutics determined by investigators and confirmed by medical records (if available) with ≥12 weeks of treatment within 5 years. ii. Participants with intolerance or AEs to anti-inflammatory protein therapeutics. iii. Participants with loss of access to anti-inflammatory protein therapeutics with ≥12 weeks of treatment within 5 years."}

Exclusion criteria

• {"criterion_text":"- 1. Significant autoimmune diseases, other than AD and well controlled mild to moderate asthma, including but not limited to: a.\tSystemic lupus erythematosus (SLE) or other complement disorders; b.\tType 1 diabetes; c.\tInflammatory Bowel Disease (IBD). d.\tMultiple Sclerosis. \"\n- 10.\tPrior randomization in this study or another study PF-07275315 or PF-07264660.\n- 11.\tHuman immunodeficiency virus (HIV) infection, or infection with hepatitis B or hepatitis C viruses.\n- 12.\tEvidence of active or latent tuberculosis (TB), or history of inadequately treated infection with Mycobacterium TB.\n- 13.\tInvestigator 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- 2.\tHistory 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. Participants with such a history need to have and know how to use an epinephrine injection (eg, EpiPen).\n- 3.\tHistory of any recent, clinically significant infection.\n- 4.\tHistory of or current evidence of other 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.\n- 5.\tRecent exposure to live or attenuated vaccines within 2 weeks of the screening.\n- 6.\tAny malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.\n- 7.\tAny 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. a.\tAt 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 Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 5 years, the participant will not be included in the study. b.\tAt the Baseline visit (Day 1), 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- 8. Current use of any prohibited concomitant medication(s):  Oral or parenteral corticosteroids, or other systemic anti-inflammatory/ immunosuppressant small molecule drugs to treat AD within 4 weeks prior to Day 1 and through end of study.  Topical corticosteroids, phosphodiesterase-4 (PDE4) or Janus kinase (JAK) inhibitors, or other anti-inflammatory drugs (eg, CalciNeurin Inhibitors [CNIs]) within 2 weeks prior to Day 1 and through end of study.  Stages 1.2, and 4 ONLY: Prior or concurrent treatment with any systemic JAK inhibitors for the treatment of AD is exclusionary. However, participants who may have received a JAK inhibitor as part of a clinical trial and who were not considered a treatment failure or who had been treated with a JAK inhibitor but discontinued treatment due to lack of access or other reason not related to safety or lack of efficacy may be eligible if the JAK inhibitor was discontinued at least 4 weeks or 5 half-lives (whichever is longer) prior to Day 1. Participants who either have failed treatment or had an adverse reaction are not eligible to enroll in the study.  Stage 3 ONLY: Systemic JAK inhibitors within 4 weeks or 5 half-lives (whichever is longer) prior to Day 1 and through end of study.  Stages 1,2, and 4 ONLY: Prior or concurrent use of anti-inflammatory protein therapeutics (to treat AD or asthma) including but not limited to anti-Interleukin-33 (IL-33), anti-Interleukin-5 (IL-5), anti-Interleukin-4 (IL-4)/Interleukin-13 (IL-13), anti-thymic stromal lymphopoietin (TSLP), and/or IL-13 targeted therapies are exclusionary.  Stage 3 ONLY: Anti-inflammatory protein therapeutics (to treat AD) within 6 weeks prior to Day 1 and through end of study. Herbal medications with presumed anti-inflammatory properties must be discontinued at least 1 week or 5 half-lives (whichever is longer) prior to Day 1 and through end of study.  Oral and parenteral anti-infectives within 2 weeks or 5 half-lives (whichever is longer) prior to Day 1 and through end of study.  Participants who are on a stable (not as needed [PRN]) dose of an oral antihistamine for treatment of AD for at least 4 weeks before screening may be eligible provided that the dose is not changed during the course of the study.\n- 9.\tPrevious 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)."}

Primary endpoints

• {"endpoint_text":"- \"EASI75 (≥75% improvement from baseline) at Week 16\"","definition_or_measurement_approach":"EASI75 defined as ≥75% improvement from baseline in Eczema Area and Severity Index (EASI) measured at Week 16."}

Secondary endpoints

• {"endpoint_text":"- \"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\"","definition_or_measurement_approach":"vIGA: validated Investigator Global Assessment on a 5-point scale; endpoint requires score 0 or 1 and ≥2-point reduction from baseline at scheduled time points."}
• {"endpoint_text":"- \"EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16\"","definition_or_measurement_approach":"EASI75 measured at scheduled time points other than Week 16; defined as ≥75% improvement from baseline."}
• {"endpoint_text":"- \"Percent change from baseline in EASI total score at scheduled time points\"","definition_or_measurement_approach":"Percent change in total EASI score from baseline measured at scheduled time points."}
• {"endpoint_text":"- \"Incidence of treatment emergent AEs, clinically significant changes in vital signs, electrocardiogram (ECG), and laboratory tests\"","definition_or_measurement_approach":"Safety assessments include incidence of treatment-emergent adverse events and clinically significant changes in vital signs, ECG, and laboratory tests."}

Methods

• Patient invite letter (documents: K2a, K13a, K16a) — country-specific versions (PL and DE).
• Study poster (documents: K3a, K15, K15a) — country-specific (PL and DE).
• Study brochure (documents: K4a, K12a, K16a) — country-specific (PL and DE).
• Digital media board / DIGITALMEDIABOARD (document: K5a) — digital channel.
• Facebook Page (document: K6a / placeholders) — social media recruitment.
• Website (document: K11a and K11a web placeholders) — study website recruitment materials (PL and DE).
• Outbound call script (document: K7a) — phone outreach.
• Prescreener scripts and prescreener additional question (documents: K8a, K9a) — pre-screening via calls or online.
• Referral confirmation email (documents: K10a) — email communications to referred participants.
• Patient invite letters and part-specific invite letters (K13a, K14) targeted to potential participants with AD.

Poland

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

15-11-2025

Processing Time Days

499

Number Of Sites

6

Number Of Participants

50

Germany

Earliest CTIS Part Ii Submission Date

05-07-2024

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

500

Number Of Sites

3

Number Of Participants

20

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

eConsent; eCOA

Name

Icon Clinical Research Limited

Responsibilities

Central Lab

Name

Canfield Scientific Inc.

Responsibilities

Camera

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"eConsent","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Camera","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}