CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
BG00011 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01371305
NCT01371305Phase 2Completed
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Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Biogen·interventional·Posted Jun 10, 2011·Updated Feb 28, 2020

In Brief

A Phase 2 clinical trial evaluating BG00011 and Placebo for Idiopathic Pulmonary Fibrosis (IPF). Completed, enrolled 41 participants across 10 sites.

Detailed Summary

The primary objective of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as STX-100) in participants with IPF. The Secondary objectives are to estimate the pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple, escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis (IPF)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2011
Enrollment StartJul 16, 2012
Primary CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.1 years ago

Interventions

BG00011drug

BG00011 will be administered at varying doses via subcutaneous (SC) injection

Placebodrug

Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.