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NCT05375955 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 263
- Enrollment target
NCT05375955 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 263 participants.
The verdict
NCT05375955, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 263 participants
- Enrollment target
Study 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.
Interventions
- DRUG Vehicle ointment
- DRUG PF-07038124 ointment 0.01%
- DRUG PF-07038124 ointment 0.03%
- DRUG PF-07038124 ointment 0.06%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2023-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05375955
The ClinicalTrials.gov registry entry for NCT05375955 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 263 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Vehicle ointment is the first listed.
NCT05375955 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05375955 about?
NCT05375955 is a clinical study titled "A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.". 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 ...
What is the current status of trial NCT05375955?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 263 participants. The study started on 2022-09-26. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT05375955?
The interventions under investigation include: Vehicle ointment (DRUG), PF-07038124 ointment 0.01% (DRUG), PF-07038124 ointment 0.03% (DRUG), PF-07038124 ointment 0.06% (DRUG).
Who is sponsoring clinical trial NCT05375955?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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