A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Phase
Recruitment status
Participants
Lead sponsor
Start date
Number of sites

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. * 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).
Short title
A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
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

Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design

  1. The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.

    Timeframe: Week 16

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

  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

    Timeframe: Screening through study completion, an average of 36 weeks.

    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. The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16

    Timeframe: All scheduled timepoints other than Week 16, screening through study completion, an average of 36 weeks.

    EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16

  3. The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points

    Timeframe: Screening through study completion, an average of 36 weeks.

    Percent change from baseline in EASI total score at scheduled time points

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

    Timeframe: Screening - Week 36

    Incidence of treatment emergent AEs

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

    Timeframe: Screening - Week 36

    Incidence of clinically significant changes in vital signs

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

    Timeframe: Screening - Week 36

    Incidence of clinically significant changes in ECG

  7. The number and % of participants with clinically significant changes in laboratory tests

    Timeframe: Screening - Week 36

    Incidence of clinically significant changes in laboratory tests

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Must meet the following AD criteria:

  1. Participants aged 18 years or older

  2. Clinical diagnosis of chronic atopic dermatitis:

    1. for at least 6 months prior to Day 1 with diagnosis confirmed by photograph;
    2. 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;
    3. Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits).
    4. 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:

  3. BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).

  4. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

- Medical Conditions:

  1. 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.

  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.

  3. Any of the following acute or chronic infections or infection history:

    1. Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening;
    2. Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
    3. 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.
    4. Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;
  4. 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.

  5. 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:

  6. Current use of any prohibited concomitant medication(s).

  7. 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:

  8. 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).

  9. HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.

  10. 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.

Sources for eligibility

  • Allervie Clinical ResearchBirmingham, United StatesRecruiting
  • Onyx Clinical Research - PeoriaPeoria, United StatesRecruiting
  • Medical Dermatology SpecialistsPhoenix, United StatesRecruiting
  • Onyx Clinical ResearchPhoenix, United StatesRecruiting
  • Banner - University Medicine Dermatology ClinicTucson, United StatesRecruiting
  • Marvel Clinical ResearchHuntington Beach, United StatesRecruiting
  • California Allergy and Asthma Medical GroupLos Angeles, United StatesRecruiting
  • University Dermatology Trials, INC.Newport Beach, United StatesRecruiting
  • Northridge Clinical TrialsNorthridge, United StatesRecruiting
  • Profound Research LLCOceanside, United StatesRecruiting
  • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.San Diego, United StatesRecruiting
  • West Dermatology La JollaSan Diego, United StatesRecruiting
  • Sunwise Clinical ResearchWalnut Creek, United StatesTerminated
  • AboutSkin Research, LLCGreenwood Village, United StatesTerminated
  • Renaissance Research and Medical GroupCape Coral, United StatesActive, not recruiting
  • Florida International Medical ResearchCoral Gables, United StatesTerminated
  • Revival ResearchDoral, United StatesRecruiting
  • St. Jude Clinical ResearchDoral, United StatesTerminated
  • SouthCoast Research CenterMiami, United StatesTerminated
  • Floridian Research Institute LlcMiami, United StatesRecruiting
  • Global Health Research Center, Inc.Miami Lakes, United StatesRecruiting
  • Ziaderm Research LLCNorth Miami Beach, United StatesRecruiting
  • Clinical Neuroscience Solutions, Inc.Orlando, United StatesRecruiting
  • GCP Research, Global Clinical professionalsSt. Petersburg, United StatesRecruiting
  • ForCare Clinical ResearchTampa, United StatesRecruiting

And 73 more, listed on the interactive page.

Sources for sites

  • 2023
  • 2023-505218-68-00
Sources for references

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)