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Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-2)

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3

Conditions

Dermatitis, Atopic

Treatments

Drug: PF-04965842 100 mg
Drug: PF-04965842 200 mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03575871
MONO-2 (Other Identifier)
2018-001136-21 (EudraCT Number)
B7451013

Details and patient eligibility

About

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Enrollment

391 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 12 years of age or older with a minimum body weight of 40 kg
  • Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
  • Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion criteria

  • Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
  • Prior treatment with JAK inhibitors
  • Other active nonAD inflammatory skin diseases or conditions affecting skin
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
  • Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

391 participants in 3 patient groups, including a placebo group

PF-04965842 100 mg
Experimental group
Treatment:
Drug: PF-04965842 100 mg
PF-04965842 200 mg
Experimental group
Treatment:
Drug: PF-04965842 200 mg
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

115

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Data sourced from clinicaltrials.gov

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