CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 263 enrolled
Drug / intervention
PF-07038124 ointment 0.01% +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05375955
NCT05375955Phase 2Completed

A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS

Pfizer·interventional·Posted May 17, 2022·Updated Oct 2, 2024

In Brief

A Phase 2 clinical trial evaluating PF-07038124 ointment 0.01%, Vehicle ointment, and 2 other interventions for Atopic Dermatitis and Plaque Psoriasis. Completed, enrolled 263 participants across 39 sites in 4 countries.

Detailed Summary

The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form. This study is seeking participants who If they have Atopic Dermatitis (AD): * Have a diagnosis for at least 3 months * Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA) * Have percent Body Surface Area (%BSA) covering 5% up to 40% * A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period If they have plaque psoriasis (PsO): * Have a diagnosis for at least 6 months * Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA) * Have percent Body Surface Area (%BSA) covering 2% up to 20% All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group. PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective. Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Japan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMay 17, 2022
Enrollment StartSep 26, 2022
Primary CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.1 years ago

Interventions

PF-07038124 ointment 0.01%drug

Atopic Dermatitis and Plaque Psoriasis

Vehicle ointmentdrug

Atopic Dermatitis and Plaque Psoriasis

PF-07038124 ointment 0.03%drug

Atopic Dermatitis and Plaque Psoriasis

PF-07038124 ointment 0.06%drug

PF-07038124 ointment 0.06% (Plaque Psoriasis only)