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Phase 2b Randomized Double‑Blind Study of Oral PF‑08049820 in Adults with Moderate to Severe Atopic Dermatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have moderate to severe Atopic Dermatitis, a chronic condition that causes red, itchy patches of skin. The investigational medicine being tested is an oral tablet named PF-08049820. Participants may receive different doses of this tablet or a matching inactive tablet (placebo).

The purpose is to compare how well the various doses improve skin symptoms versus placebo after approximately three months, using a scoring system called the EASI score, which measures the extent and severity of the rash.

During the trial, participants take the assigned tablet once daily for several weeks. At scheduled visits they have simple skin examinations and answer questions about itch intensity, using tools such as the vIGA rating (which classifies the skin as clear, almost clear, or worse) and the PP-NRS4 scale (a short questionnaire where higher numbers indicate more itching). Safety is monitored through checks for side effects, basic lab tests, vital signs, and heart scans (ECG). The study continues for about 12 weeks before the results are evaluated.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessments
after joining the study, you will attend a baseline visit where your skin condition will be measured using the eczema area and severity index (easi) and other safety tests will be performed.
the information collected at this visit will be used to compare future results.
Step 2
Randomization and start of medication
you will be assigned, in a blinded manner, to receive either the test medicine pf-08049820 or a matching placebo.
both forms are oral tablets and are identical in appearance.
Step 3
Medication administration (weeks 0‑12)
you will take one oral tablet each day as directed by the study staff.
the tablet dosage listed in the study materials is 0 mg; the exact amount you should take will be confirmed at the start of treatment.
this daily dosing will continue for a total of twelve weeks.
Step 4
Regular study assessments
throughout the twelve‑week period you will attend scheduled visits (often weekly or at predefined intervals) where your eczema severity (easi), itch level, and safety measurements such as laboratory tests will be recorded.
any side effects you experience will be reported during these visits.
Step 5
Week 12 primary efficacy assessment
at week 12 a comprehensive evaluation will be performed to determine the percent change from baseline in the easi score.
this assessment will be used to compare the effect of the test medicine with the placebo.
Step 6
End‑of‑study procedures
after the week 12 visit, a final study visit will be scheduled to complete any remaining safety assessments and to collect final study data.
you will be instructed on any steps needed after the study ends.

Who can join the trial?

11 criteria

Be at least 18 years old (or meet the local legal age for consent).
Have a confirmed diagnosis of Atopic Dermatitis (also called atopic eczema) that has lasted for at least 6 months, proven by photographs and medical records.
Have not gotten enough relief from standard skin creams or ointments (topical medications) after using them for at least 4 weeks in the past year, or have a documented reason they cannot use those treatments because of safety concerns.
Either have never used advanced anti‑inflammatory protein drugs or JAK inhibitor medicines, or if they have used them before, they stopped because they could not get the medication any more or because of side effects; people who tried these drugs and did not respond well are not eligible.
Show moderate to severe disease at the screening visit, which means:
- Affected skin area (called Body Surface Area (BSA)) is at least 10% and no more than 60% of the body (with only a limited number of participants allowed to have 41%‑60% BSA).
- The doctor’s overall assessment score (vIGA) is 3 or higher on a scale where higher numbers mean worse disease.
- The eczema severity score (EASI) is 16 or higher.
- The itch intensity rating (PP‑NRS, a scale from 0 = no itch to 10 = worst imaginable itch) is 4 or higher at screening and also an average of 4 or higher during the week before randomization, with at least four daily entries.
- Have a Body Mass Index (BMI) between 17.5 and 40 and weigh more than 45 kg (about 100 lb).
- Be willing and able to attend all scheduled study visits, follow the treatment plan, and complete all required study procedures.
- If able to become pregnant, agree to use a highly effective form of contraception (non‑estrogen hormonal method) during the study, or stop hormone replacement therapy if needed to confirm menopausal status.

Who cannot join the trial?

26 criteria

Having other skin problems that could affect the study results or how the medicine works.
Having had a major injury or surgery within the last month.
Having a medical or mental‑health condition that makes participation unsafe, especially if you have had thoughts of suicide in the past year, suicide attempts in the past five years, or a depression score that is very high.
Taking any medicines that the study says are not allowed.
Using a tanning bed or receiving light therapy for eczema more than twice a week within four weeks before the screening visit.
Receiving a live (weakened) vaccine within 12 weeks before the first dose of the study drug, or planning to get one during the study.
Not having a good response to strong anti‑inflammatory medicines or to a class of drugs called JAK inhibitors that are sometimes used for eczema.
Having taken an experimental (investigational) drug or vaccine within 30 days (or a longer time based on how long the drug stays in the body) before the first study dose, or being in another experimental study at the same time.
Having kidney problems, shown by an eGFR (a test of kidney function) lower than 60 mL/min/1.73 m².
Having liver problems, shown by any of the following lab results:
- Total bilirubin 1.5 times the normal limit (bilirubin is a substance the liver processes).
- AST or ALT (liver enzymes) 2 times the normal limit.
- Having blood‑count problems, such as:
  - Low neutrophils (ANC ≤ 1,500 per mm³), which are a type of white blood cell.
  - Low platelets (≤ 120,000 per mm³), which help blood clot.
  - Low hemoglobin (≤ 13 g/dL for men or ≤ 12 g/dL for women), which carries oxygen.
  - Having an active infection that needs strong medicines (like antibiotics, antivirals, or antifungals) within two weeks before the first dose, or a skin infection within one week.
  - Having a heart test (standard 12‑lead ECG) that shows serious problems, such as a QTc interval longer than 450 ms, major heart block, or other dangerous rhythm issues.
  - Having a recent history (within the past two years) of alcohol abuse, binge drinking (5 or more drinks for men, 4 or more for women in about two hours), or use of illegal drugs that could affect safety or ability to follow the study plan.
  - Being a study staff member, a family member of staff, or an employee of the sponsor who is directly involved in the study.
  - Being allergic (hypersensitive) to the study drug PF‑08049820 or any of its inactive ingredients.
  - Having had a serious skin infection that needed hospital care or strong IV antibiotics within about three months before the first dose.
  - Having an uncontrolled chronic disease that often needs oral steroids, such as severe asthma with two or more flare‑ups in the past year that required steroid treatment or a hospital stay.
  - Having a recent (within about three months) severe, worsening, or uncontrolled disease of major organs (kidney, liver, blood, stomach, metabolism, hormones, lungs, heart, or nerves).
  - Being on medication that suppresses the immune system for a chronic infection (like certain fungal or bacterial infections), which could risk reactivation of the infection.
  - Having had cancer in the past five years, except for fully treated non‑metastatic basal cell or squamous cell skin cancer or early‑stage cervical cancer with no return.
  - Having an infection with HIV, hepatitis B, or hepatitis C, or testing positive for any of these viruses.
  - Having active or hidden (latent) tuberculosis (TB) or a history of TB that was not treated adequately.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Centre Hospitalier Universitaire De Lille
Verified
Lille, France
Centre Hospitalier Universitaire Rouen
Verified
Rouen, France

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Investigated drugs

PF-08049820 is an experimental oral tablet being studied as a possible new treatment for people with moderate to severe atopic dermatitis (eczema). In this trial, participants take the tablet by mouth to see if it can lower the extent and severity of their skin rash compared with not taking the active drug. Researchers are testing several different strengths of the tablet to find the safest and most effective dose.

What is already known about the treatment

PF-08049820 - PF-08049820 is taken as an oral tablet that is swallowed with water. It is still an investigational drug that has not been approved and is currently being studied in phase 2b trials for atopic dermatitis, a chronic skin inflammation. The medication works by blocking certain enzymes (JAK1) that send signals for inflammation, which helps reduce the redness, itching and swelling of the skin. It is classified as an oral small‑molecule JAK inhibitor used for inflammatory skin disease.

Investigated diseases

Atopic Dermatitis - Atopic dermatitis is a long‑lasting skin condition that causes red, itchy patches, often on the face, elbows, knees, and hands. The rash may appear suddenly and then improve, but it commonly returns in cycles called flares. Over time, the affected skin can become thicker, dry, and more sensitive. The condition often starts in childhood but can continue into adulthood. Environmental triggers such as allergens, stress, or changes in temperature can worsen the symptoms.