CLINICAL TRIAL PROTOCOL

CLINICAL TRIAL PROTOCOL

EudraCT No.:

Document Number: c03185695-07

2014-004932-20

BI Trial No.:

1311.14

BI Investigational Product: Title:

Brief Title:

BI 655066

A phase IIa, randomized, double-blind, placebo controlled, parallel group study to assess the safety and efficacy of subcutaneously administered BI 655066/ABBV-066 (risankizumab) as add-on therapy over 24 weeks in patients with severe persistent asthma.

Efficacy and safety of BI 655066/ ABBV-066 (risankizumab) in patients with severe persistent asthma.

Clinical Phase:

IIa

Trial Clinical Monitor:

Coordinating Investigator:

Status: Version and Date:

Phone:

Fax:

Phone:

Final Protocol (revised protocol based on global amendment 5)

Version: 6.0

Date: 17 August 2017

Page 1 of 109

Proprietary confidential information. 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.

This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.

TITLE PAGE

Boehringer Ingelheim

17 Aug 2017

BI Trial No.: 1311.14

c03185695-07

Trial Protocol

Page 2 of 109

Proprietary confidential information ? 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies

CLINICAL TRIAL PROTOCOL SYNOPSIS

Name of company:

Boehringer Ingelheim

Name of finished product:

NA

Name of active ingredient:

BI 655066

Protocol date: 13 March 2015

Trial number: 1311.14

Revision date: 17 August 2017

Title of trial:

Coordinating Investigator

Trial sites: Clinical phase: Objectives: Methodology:

No. of patients: total entered: each treatment: Diagnosis : Main criteria for inclusion:

A phase IIa, randomized, double-blind, placebo controlled, parallel group study to assess the safety and efficacy of subcutaneously administered BI 655066/ABBV066 (risankizumab) as add-on therapy over 24 weeks in patients with severe persistent asthma.

Phone: Multi-center, Multi-national IIa Evaluate efficacy and safety of BI 655066 (risankizumab) compared to placebo in patients with severe persistent asthma over a 24-week treatment period. Randomized, double-blind, placebo-controlled, parallel-group study with risankizumab compared to placebo, administered subcutaneously in patients with severe persistent asthma.

Approximately 200

Approximately 200

Approximately 100

Severe persistent asthma 1. Male or female patients aged at least 18 years but not more than 75 years. 2. Pre-bronchodilator clinic measured FEV1 of 40% and 85% of predicted

normal at the screening visit. 3. A minimum of one year history of asthma diagnosed by a physician, and

have FEV1 reversibility as defined by an improvement in FEV1 12% and an absolute change of at least 200 ml starting within 15 to 30 minutes after administration of 400 ?g salbutamol (albuterol) via MDI. Reversibility testing is performed at the screening Visit (Visit 1B).

Boehringer Ingelheim

17 Aug 2017

BI Trial No.: 1311.14

c03185695-07

Trial Protocol

Page 3 of 109

Proprietary confidential information ? 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies

Name of company:

Boehringer Ingelheim

Name of finished product:

NA

Name of active ingredient:

BI 655066

Protocol date: 13 March 2015

Trial number: 1311.14

Revision date: 17 August 2017

If reversibility criteria are not met, the patient may still be randomized if there is:

Documented evidence of reversibility with improvement in FEV1 12% above baseline and an absolute increase of at least 200 ml in the 2 years prior to Visit 2 (randomization visit) or

Documented evidence of airway hyperresponsiveness (methacholine: PC20 of ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download