Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF

Phase 4

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Nintedanib; Drug: Pirfenidone

• Registration Number: NCT02579603
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.

A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-16
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Primary Completion: 2017-01-03
• Study Completion: 2017-01-31
• Results First Submitted: 2017-12-07
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-17
• Last Update Submitted: 2018-01-17
• Results First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nintedanib	Nintedanib	Nintedanib 150 mg bid
Nintedanib and Pirfenidone	Nintedanib	Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid
Nintedanib and Pirfenidone	Pirfenidone	Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With On-treatment Gastrointestinal (GI) AEs (SOC GI Disorders) From Baseline to Week 12	Baseline to week 12	Percentage of patients with on-treatment gastrointestinal (GI) Adverse events (AEs) (SOC GI disorders) from baseline to week 12.; On-treatment AEs were defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive).

Secondary Outcome Measures

Name	Time	Method
Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4	baseline, prior to intake of study medication on week 2 and week 4	Predose plasma concentrations at steady state (Cpre,ss) of nintedanib at baseline (Visit 3), Week 2 (Visit 4) and Week 4 (Visit 5)
Predose Plasma Concentrations at Steady State (Cpre,ss) of Pirfenidone	Prior to intake of study medication on week 2 and week 4	Predose plasma concentrations at steady state (Cpre,ss) of pirfenidone at Week 2 (Visit 4) and Week 4 (Visit 5)

Trial Locations

Locations (23)

Western CT Medical Group, P.C.; 🇺🇸 Danbury, Connecticut, United States

HOP Avicenne; 🇫🇷 Bobigny, France

HOP de la Cavale Blanche; 🇫🇷 Brest, France

HOP Louis Pradel; 🇫🇷 Bron cedex, France

HOP Pasteur; 🇫🇷 Nice, France

HOP Calmette; 🇫🇷 Lille, France

Klinik Donaustauf; 🇩🇪 Donaustauf, Germany

HOP Bichat; 🇫🇷 Paris, France

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH; 🇩🇪 Essen, Germany

A.O.U. Policlinico Vittorio Emanuele; 🇮🇹 Catania, Italy

Osp. S. Giuseppe Fatebenefratelli; 🇮🇹 Milano, Italy

A.O.U. Senese Policlinico Santa Maria alle Scotte; 🇮🇹 Siena, Italy

Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Netherlands

The Lung Research Center, LLC; 🇺🇸 Chesterfield, Missouri, United States

Minnesota Lung Center; 🇺🇸 Minneapolis, Minnesota, United States

HOP Pontchaillou; 🇫🇷 Rennes, France

Lowcountry Lung and Crit Care; 🇺🇸 Charleston, South Carolina, United States

Tulane University Hospital and Clinic; 🇺🇸 New Orleans, Louisiana, United States

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Concordia Hospital; 🇨🇦 Winnipeg, Manitoba, Canada