NCT01732211

A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis

A PHASE 2 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, 20-WEEK SAFETY, TOLERABILITY, AND EFFICACY STUDY OF PD 0360324 IN ADULT SUBJECTS WITH CHRONIC PULMONARY SARCOIDOSIS

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies.

Detailed description

The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.

Conditions

• Pulmonary Sarcoidosis

Interventions

Type	Name	Description
BIOLOGICAL	PD 0360324	100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;
OTHER	Normal Saline for injection	normal saline Q2W via intravenous infusion for 12 weeks

Timeline

• Start date: 2013-03-15
• Primary completion: 2013-09-23
• Completion: 2013-09-23
• First posted: 2012-11-22
• Last updated: 2020-01-06
• Results posted: 2020-01-06

Locations

5 sites across 1 country: United States