Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-08049820 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 2 | EXPERIMENTAL | Stages 1 and 2: Tablets taken by mouth daily for 12 weeks |
| Arm 3 | EXPERIMENTAL | Stages 1 and 2: Tablets taken by mouth daily for 12 weeks |
| Arm 1 | EXPERIMENTAL | Stages 1 and 2: Tablets taken by mouth daily for 12 weeks |
| Arm 4 | PLACEBO_COMPARATOR | Stages 1 and 2: Tablets taken by mouth daily for 12 weeks |
| Baseline Midazolam | OTHER | Participants will receive a single dose of 2 mg midazolam in the morning on Day 1 |
| Baseline dabigatran etexilate | OTHER | Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 |
| Baseline oral contraceptives | OTHER | Participants will receive a single dose of Portia (30 mcg of ethinyl estradiol (EE) and 150 mcg of levonorgestrel (LN)) or equivalent oral tablet in the morning on Day 1 |
| Drug Drug Interaction (DDI) midazolam | EXPERIMENTAL | Participants will receive a single dose of 2 mg midazolam in the morning on Days 2 and 10 only with PF-08049820 Days 1 to 10 |
| DDI dabigatran etexilate | EXPERIMENTAL | Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 only with PF-08049820 Days 1 to 2 |
| DDI oral contraceptives | EXPERIMENTAL | Participants will receive a single dose of Portia (30 mcg of EE and 150 mcg of LN) or equivalent oral tablet in the morning on Day 1 only with PF-08049820 on Days 1 to 2 |
| Name | Type | Description |
|---|---|---|
| PF-08049820 | DRUG | Tablet |
| Placebo | DRUG | Tablet |
| Midazolam | DRUG | Administered orally |
| Dabigatran Etexilate | DRUG | Administered orally |
| Portia (EE and LN) or equivalent oral tablet | DRUG | Administered orally |
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 baselin...
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PF-08049820 is an investigational small molecule drug being developed by Pfizer for the treatment of atopic dermatitis, also known as eczema. It is currently in Phase 2 clinical development and has not been approved by the FDA. Pfizer is evaluating it in randomized, double-blind, controlled clinical trials.
PF-08049820 is being studied as a treatment for atopic dermatitis, commonly called eczema, in adults. It is an investigational therapy and is not yet approved for any indication. Clinical testing is ongoing to evaluate its use in this inflammatory skin condition.
PF-08049820 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating this investigational small molecule for atopic dermatitis.
PF-08049820 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for atopic dermatitis or any other indication. Two trials have been conducted to date, one Phase 2 study and one Phase 1 study.
PF-08049820 has been studied in two clinical trials. NCT07216027 is a recruiting Phase 2 study in adults with atopic dermatitis across the United States, Bulgaria, Canada, China, Czechia, France, Japan, and Poland, enrolling 165 participants. NCT07190430 is a completed Phase 1 drug interaction study in 16 healthy adult female participants in the United States.
Across the two clinical trials of PF-08049820, total planned enrollment is 181 participants. The Phase 2 atopic dermatitis study, NCT07216027, plans to enroll 165 adults, while the completed Phase 1 study, NCT07190430, enrolled 16 healthy adult female participants.