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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

NCT03575871 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2020-04-21

Study results available
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Summary

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.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

PF-04965842 100 mg

PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks

DRUG

PF-04965842 200 mg

PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks

DRUG

Placebo

Placebo, administered as two tablets to be taken orally once daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-29
Primary Completion
2019-08-13
Completion
2019-08-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Germany
  • Hungary
  • Japan
  • Latvia
  • Poland
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03575871 on ClinicalTrials.gov