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Clinical Trial Results:
A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer’s Disease

Summary
EudraCT number	2017-002702-12
Trial protocol	ES DE LT GB SE DK FI HU FR BE PL IT
Global end of trial date	31 May 2019

Results information
Results version number	v2(current)
This version publication date	29 Jul 2020
First version publication date	11 Jun 2020
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

BN40031

ISRCTN number

-

US NCT number

NCT03491150

WHO universal trial number (UTN)

-

Sponsor organisation name

F. Hoffmann-La Roche AG

Sponsor organisation address

Grenzacherstrasse 124, Basel, Switzerland, CH4070

Public contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

Scientific contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

31 May 2019

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

31 May 2019

Was the trial ended prematurely?

Yes

Main objective of the trial

To assess the long-term safety of Crenezumab

Protection of trial subjects

All study subjects were required to read and sign an Informed Consent Form.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

11 Apr 2018

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 12

Country: Number of subjects enrolled

Germany: 3

Country: Number of subjects enrolled

Australia: 3

Country: Number of subjects enrolled

Spain: 15

Country: Number of subjects enrolled

Finland: 3

Country: Number of subjects enrolled

France: 1

Country: Number of subjects enrolled

United Kingdom: 2

Country: Number of subjects enrolled

Hong Kong: 1

Country: Number of subjects enrolled

Italy: 4

Country: Number of subjects enrolled

Korea, Republic of: 5

Country: Number of subjects enrolled

Lithuania: 1

Country: Number of subjects enrolled

Mexico: 6

Country: Number of subjects enrolled

Poland: 1

Country: Number of subjects enrolled

Russian Federation: 6

Country: Number of subjects enrolled

Turkey: 1

Country: Number of subjects enrolled

United States: 85

Worldwide total number of subjects

149

EEA total number of subjects

30

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

23

From 65 to 84 years

118

85 years and over

8

Subject disposition

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Recruitment details

The study was conducted at 66 centers in 16 countries.

Screening details

A total of 149 subjects were enrolled at 66 centers. These 149 subjects represented the Safety Analysis population and data for this population is presented here.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Parent Placebo

Arm description

Subjects (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Arm type

Placebo

Investigational medicinal product name

Crenezumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Crenezumab was administered by Intravenous (IV) infusion every 4 weeks (Q4W) at a dose of 60mg/kg.

Parent Crenezumab

Arm description

Subjects (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Arm type

Experimental

Investigational medicinal product name

Crenezumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Crenezumab was administered by Intravenous (IV) infusion every 4 weeks (Q4W) at a dose of 60mg/kg.

Number of subjects in period 1	Parent Placebo	Parent Crenezumab
Started	76	73
Completed	0	0
Not completed	76	73
Consent withdrawn by subject	1	2
Adverse event, non-fatal	1	-
Unknown	-	1
Study Terminated by Sponsor	74	70

Baseline characteristics

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Reporting group title

Parent Placebo

Reporting group description

Subjects (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Reporting group title

Parent Crenezumab

Reporting group description

Subjects (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Reporting group values	Parent Placebo	Parent Crenezumab	Total
Number of subjects	76	73	149
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	10	13	23
From 65-84 years	59	59	118
85 years and over	7	1	8
Age Continuous
Units: Years
arithmetic mean (standard deviation)	73.8 ( 7.6 )	72.0 ( 7.6 )	-
Sex: Female, Male
Units:
Female	37	38	75
Male	39	35	74
Race/Ethnicity, Customized
Units: Subjects
Hispanic or Latino	6	3	9
Not Hispanic or Latino	69	69	138
Not Stated	1	1	2
Race/Ethnicity, Customized
Units: Subjects
Asian	4	2	6
Black or African American	0	1	1
Unknown	0	3	3
White	72	67	139

End points

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Reporting group title

Parent Placebo

Reporting group description

Subjects (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Reporting group title

Parent Crenezumab

Reporting group description

Subjects (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Primary: Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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End point title

Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) ^[1]

End point description

An Adverse Event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

End point type

Primary

End point timeframe

Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses were performed as this study has only one arm.

End point values	Parent Placebo	Parent Crenezumab
Number of subjects analysed	76	73
Units: Percentage of Subjects
number (not applicable)
AEs	32.9	42.5
SAEs	3.9	5.5

No statistical analyses for this end point

Primary: Percentage of Subjects with Anti-Crenezumab Antibodies

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End point title

Percentage of Subjects with Anti-Crenezumab Antibodies ^[2]

End point description

Please note that for this Outcome Measure, no Subjects were evaluated at all as the existing immunogenicity data from a parent study (Study BN29552) showed a low potential of Crenezumab to induce Anti-Drug Antibodies (ADAs).

End point type

Primary

End point timeframe

Baseline up to end of study (up to 54 weeks).

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses were performed as this study has only one arm.

End point values	Parent Placebo	Parent Crenezumab
Number of subjects analysed	0 ^[3]	0 ^[4]
Units: Percentage of Subjects
number (not applicable)

Notes
[3] - ADAs were not collected in this study due to low induction potential of Crenezumab.
[4] - ADAs were not collected in this study due to low induction potential of Crenezumab.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.0

Reporting group title

Parent Placebo

Reporting group description

Subjects (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Reporting group title

Parent Crenezumab

Reporting group description

Subjects (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Serious adverse events	Parent Placebo	Parent Crenezumab
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 76 (3.95%)	4 / 73 (5.48%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
FALL
subjects affected / exposed	0 / 76 (0.00%)	1 / 73 (1.37%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
CEREBROVASCULAR ACCIDENT
subjects affected / exposed	1 / 76 (1.32%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
OPTIC ISCHAEMIC NEUROPATHY
subjects affected / exposed	0 / 76 (0.00%)	1 / 73 (1.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
INCARCERATED INGUINAL HERNIA
subjects affected / exposed	1 / 76 (1.32%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RECTAL HAEMORRHAGE
subjects affected / exposed	1 / 76 (1.32%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
PNEUMONIA
subjects affected / exposed	0 / 76 (0.00%)	1 / 73 (1.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
UROSEPSIS
subjects affected / exposed	0 / 76 (0.00%)	1 / 73 (1.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Parent Placebo	Parent Crenezumab
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 76 (5.26%)	4 / 73 (5.48%)
Injury, poisoning and procedural complications
FALL
subjects affected / exposed	4 / 76 (5.26%)	4 / 73 (5.48%)
occurrences all number	5	4

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

05 Aug 2018

Following updates were made: [1] Improved alignment with CREAD 1 and 2 parent studies; [2] Language updated for China as China extensions activated in CREAD 1/2 studies; [3] Updating of information to align with latest Investigator's brochure; [4] Updates made to Exploratory Efficacy Objectives; [5] Number of Sites amended; [6] Recruitment period updated based on shortening of recruitment periods for CREAD 1/2 studies; [7] First Dose Window duration amended; [8] Update to Inclusion Criteria; [9] Addition of text to recognize country variability in designation of non-investigational medicinal product/investigational medicinal product status to positron emission tomography (PET) tracers; [10] Modification of physical and neurologic examination assessment; [11] Harmonisation of Vital Signs language and [12] Further updates including to Lab Samples, PD Biomarkers, Safety, Patient withdrawal, order of Clinical Assessments, timing of Brain MRI and Schedule of Activities.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.

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The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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