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PF-06651600 for the Treatment of Alopecia Areata

NCT03732807 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 718

Last updated 2022-02-24

Study results available
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Summary

This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Conditions

Interventions

DRUG

PF-06651600 Induction Dose

Oral tablets taken once daily (QD)

DRUG

PF-06651600 Maintenance Dose #1

Oral tablets taken QD

DRUG

PF-06651600 Maintenance Dose #2

Oral tablets taken QD

DRUG

PF-06651600 Maintenance Dose #3

Oral tablets taken QD

DRUG

Placebo

Oral tablets taken QD

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
2018-12-03
Primary Completion
2020-12-31
Completion
2021-06-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Chile
  • China
  • Colombia
  • Czechia
  • Germany
  • Hungary
  • Japan
  • Mexico
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

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 NCT03732807 on ClinicalTrials.gov