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Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease

NCT03395184 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2024-10-30

Study results available
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Summary

The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.

Conditions

Interventions

DRUG

PF-06651600 Placebo

12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks

DRUG

PF-06651600

200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks

DRUG

Placebo PF-06700841

12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks

DRUG

PF-06700841

60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2023-10-19
Completion
2023-10-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Canada
  • Croatia
  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Lebanon
  • Poland
  • Russia
  • Saudi Arabia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Tunisia
  • Turkey (Türkiye)
  • Ukraine
  • United Arab Emirates

Study Locations

More Related Trials

Entities

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 NCT03395184 on ClinicalTrials.gov