OncRef

Clinical Trial: NCT02974868

Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Pfizer
Information Provided By:Pfizer
Last Update Posted:2020-05-26

Study Overview

Brief Summary

This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.

Official Title

A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD

Conditions

Alopecia Areata

Intervention / Treatment

  • Drug: PF-06651600
  • Drug: PF-06700841
  • Drug: Placebo

Other Study ID Numbers

  • B7931005
  • 2016-004048-13
  • ALLEGRO
  • 2016

Start Date (Actual)

2016-12-15

Primary Completion Date (Actual)

2019-05-15

Study Completion Date (Actual)

2019-05-15

Enrollment (Actual)

142

Study Type

Interventional

Phase

Phase 2