NCT07216027 A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
| NCT ID | NCT07216027 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pfizer |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2028-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 165 participants in total. It began in 2025-11-20 with a primary completion date of 2028-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin. The study is seeking participants who: 1. Are 18 to 64 years of age; 2. Were confirmed to have AD at least 6 months ago; 3. Do not have a suitable prescribed medicine for AD; 4. Are considered by their doctors to have moderate to severe AD. The study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.
Eligibility Criteria
Inclusion Criteria: Participants must meet the following criteria: 1. Are 18 to 64 years of age 2. Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs 3. Have moderate to severe AD as defined by the following at screening and baseline visits: * Affected body surface area (BSA) greater than or equal to 10% and up to 60%; * Validated Investigator's Global Assessment (vIGA) greater than or equal to 3; * Eczema Area and Severity Index (EASI) greater than or equal to 16; AND -Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit 4. Do not have a suitable prescribed medicine for AD. 5. Body Mass Index (BMI) of 18 to 38 kg/m2 and a total body weight greater than 48 kg (106 lbs) Exclusion Criteria: Participants must not meet the following criteria: 1. Have an infection that requires treatment 2. Have other skin conditions other than AD 3. Have severe uncontrolled asthma 4. Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07216027 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07216027 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07216027 currently recruiting?
Yes, NCT07216027 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07216027 trial being conducted?
This trial is being conducted at Scottsdale, United States, Huntington Beach, United States, Los Angeles, United States, Northridge, United States and 11 additional locations.
Who is sponsoring the NCT07216027 clinical trial?
NCT07216027 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 165 participants.
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