PF-07275315
Drugsubcutaneous injection
NCT Number: NCT05995964
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Australian Clinical Research Network, Sydney, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Must meet the following AD criteria:
Other Inclusion Criteria:
Exclusion criteria
subcutaneous injection
subcutaneous injection
subcutaneous injection
Time frame: Week 16
EASI75 (≥75% improvement from baseline) at Week 16
Time frame: 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
Time frame: 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
Time frame: Screening through study completion, an average of 36 weeks.
Percent change from baseline in EASI total score at scheduled time points
Time frame: Screening - Week 36
Incidence of treatment emergent AEs
Time frame: Screening - Week 36
Incidence of clinically significant changes in vital signs
Time frame: Screening - Week 36
Incidence of clinically significant changes in ECG
Time frame: Screening - Week 36
Incidence of clinically significant changes in laboratory tests
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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