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Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

NCT03627767 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1235

Last updated 2021-09-20

Study results available
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Summary

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

Conditions

  • Dermatitis
  • Dermatitis, Atopic
  • Eczema
  • Skin Diseases
  • Skin Diseases, Genetic
  • Genetic Diseases, Inborn
  • Skin Diseases, Eczematous
  • Hypersensitivity
  • Hypersensitivity, Immediate
  • Immune System Diseases

Interventions

DRUG

PF-04965842 100 mg

PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks

DRUG

PF-04965842 200 mg

PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks

DRUG

Placebo

Placebo, administered as two tablets to be taken orally once daily for 40 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
2018-06-11
Primary Completion
2020-09-02
Completion
2020-10-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Germany
  • Israel
  • Italy
  • Latvia
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03627767 on ClinicalTrials.gov