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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

12 Jun 2025 → ongoing

Decision date (initial)

2024-08-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer, Inc

External identifiers

EU CT number

2023-505218-68-00

ClinicalTrials.gov

NCT05995964

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To compare the efficacy of PF 07275315 and PF 07264660 versus placebo using measures of Eczema Area and Severity Index (EASI) in participants with moderate to severe AD.

Secondary objectives 3

1. To compare the efficacy of PF 07275315 and PF 07264660 versus placebo using measures of Validated Investigator Global Assessment (vIGA) in participants with moderate to severe AD.
2. "To compare the efficacy of PF 07275315 and PF 07264660 versus placebo using measures of EASI in participants with moderate to severe AD"
3. "To characterize the safety and tolerability of PF-07275315 and PF-07264660 versus placebo in participants with moderate to severe AD"

Conditions and MedDRA coding

Moderate-Severe Atopic Dermatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. "1. Participants aged 18 years or older."
2. 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 13

1. 1. Significant autoimmune diseases, other than AD and well controlled mild to moderate asthma, including but not limited to: a. Systemic lupus erythematosus (SLE) or other complement disorders; b. Type 1 diabetes; c. Inflammatory Bowel Disease (IBD). d. Multiple Sclerosis. "
2. 2. 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. Participants with such a history need to have and know how to use an epinephrine injection (eg, EpiPen).
3. 3. History of any recent, clinically significant infection.
4. 4. History 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.
5. 5. Recent exposure to live or attenuated vaccines within 2 weeks of the screening.
6. 6. Any 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.
7. 7. 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. 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 Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 5 years, the participant will not be included in the study. b. At 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.
8. 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.
9. 9. 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).
10. 10. Prior randomization in this study or another study PF-07275315 or PF-07264660.
11. 11. Human immunodeficiency virus (HIV) infection, or infection with hepatitis B or hepatitis C viruses.
12. 12. Evidence of active or latent tuberculosis (TB), or history of inadequately treated infection with Mycobacterium TB.
13. 13. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. "EASI75 (≥75% improvement from baseline) at Week 16"

Secondary endpoints 4

1. "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"
2. "EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16"
3. "Percent change from baseline in EASI total score at scheduled time points"
4. "Incidence of treatment emergent AEs, clinically significant changes in vital signs, electrocardiogram (ECG), and laboratory tests"

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 4

Locations

2 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 71 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications