Clinical Trial Results:
A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate
Summary
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EudraCT number |
2013-001492-20 |
Trial protocol |
IE GB ES PT |
Global end of trial date |
11 Aug 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jul 2020
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First version publication date |
26 Jul 2020
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Other versions |
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Summary report(s) |
Cancelled before Active Statement |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NN8226-4064
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02097264 | ||
WHO universal trial number (UTN) |
U1111-1141-3512 | ||
Sponsors
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Sponsor organisation name |
Novo Nordisk A/S
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Sponsor organisation address |
Novo Allé, Bagsvaerd, Denmark, 2880
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Public contact |
Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
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Scientific contact |
Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Aug 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Aug 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To explore the potential differences in the mechanism of action through analysis of synovial biopsies in subjects with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) after 12 weeks of treatment with NNC0109-0012 and adalimumab
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Protection of trial subjects |
N/A
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Aug 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
99999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. | ||||||
Pre-assignment
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Screening details |
N/A | ||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
N/A
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Arms
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Arm title
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NNC0109-0012 | ||||||
Arm description |
NNC0109-0012 drug product 100mg/mL | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
NNC0109-0012
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Not mentioned
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Dosage and administration details |
99999
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
NNC0109-0012
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Reporting group description |
NNC0109-0012 drug product 100mg/mL |
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End point title |
Change in the total histopathological synovitis score [1] | ||||||
End point description |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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End point type |
Primary
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End point timeframe |
N/A
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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 subjects were enrolled in the trial hence results are not available |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
All adverse events occuring during the course of the clinical trial were to be collected.
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Adverse event reporting additional description |
N/A
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
NNC0109-0012
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Reporting group description |
NNC0109-0012 drug product 100mg/mL | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No subjects were enrolled in the trial hence results are not available |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial |