Clinical Trial Results:
An open label phase 2a trial assessing the clinical effect and safety of RO5459072 in moderate to severe psoriasis.
|
Summary
|
|
EudraCT number |
2018-002446-36 |
Trial protocol |
DE |
Global end of trial date |
25 Jun 2019
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Jul 2020
|
First version publication date |
08 Jul 2020
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
BP40635
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
F. Hoffmann-La Roche, Ltd.
|
||
Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
|
||
Public contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com
|
||
Scientific contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche, Ltd., +41 616878333, genentech@druginfo.com
|
||
|
Paediatric regulatory details
|
|||
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
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
25 Jun 2019
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
25 Jun 2019
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To determine the clinical effect of oral RO5459072 in adult subjects with moderate to severe psorisis.
|
||
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 |
10 Dec 2018
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Germany: 30
|
||
Worldwide total number of subjects |
30
|
||
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) |
27
|
||
From 65 to 84 years |
3
|
||
85 years and over |
0
|
||
|
|||||||||||||||
|
Recruitment
|
|||||||||||||||
Recruitment details |
- | ||||||||||||||
|
Pre-assignment
|
|||||||||||||||
Screening details |
A total of 30 subjects were enrolled in the study. | ||||||||||||||
|
Period 1
|
|||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||
Blinding used |
Not blinded | ||||||||||||||
|
Arms
|
|||||||||||||||
|
Arm title
|
RO5459072 100 mg | ||||||||||||||
Arm description |
- | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Petesicatib
|
||||||||||||||
Investigational medicinal product code |
|||||||||||||||
Other name |
|||||||||||||||
Pharmaceutical forms |
Capsule
|
||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||
Dosage and administration details |
Two 50 mg capsules of RO5459072 (total of 100 mg) BID (twice a day) for 12 weeks
|
||||||||||||||
|
|||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
RO5459072 100 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
RO5459072 100 mg
|
||
Reporting group description |
- | ||
|
|||||||||
End point title |
Percentage of subjects that achieved a psoriasis area and severity index (PASI)75 (PASI75) response after twelve weeks of treatment [1] | ||||||||
End point description |
The PASI score was used as a measure of disease severity. The PASI was also used as a measure for the efficacy of study treatments, either as a continuous score, or as the percentage of subjects in the trial who achieve a defined level of improvement.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Week 12
|
||||||||
| 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 formal statistical analyses were performed as the study was terminated for futility. |
|||||||||
|
|||||||||
| Notes [2] - No patients achieved a PASI75 response after twelve weeks of treatment. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||
End point title |
Number of subjects that achieve a PASI50, PASI75, and PASI90 response of RO5459072 after six weeks and twelve weeks of treatment, and four weeks after completion of treatment | ||||||||||||||||||||||||||
End point description |
The PASI score was used as a measure of disease severity. The PASI was also used as a measure for the efficacy of study treatments, either as a continuous score, or as the percentage of subjects in the trial who achieve a defined level of improvement.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
|
||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||
End point title |
Change of PASI from baseline after six weeks and twelve weeks of treatment, and four weeks after completion of treatment | ||||||||
End point description |
The PASI score was used as a measure of disease severity. The PASI was also used as a measure for the efficacy of study treatments, either as a continuous score, or as the proportion of patients in the trial who achieve a defined level of improvement.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
|
||||||||
|
|||||||||
| Notes [3] - This endpoint was not analyzed due to early study termination based on lack of efficacy. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Change of static Investigator’s global assessment (sIGA) after six weeks and twelve weeks of treatment, and four weeks after completion of treatment | ||||||||||||||||||||||||||||||||||||||||
End point description |
The Investigator’s Global Assessment (IGA, also known as Physician’s Global Assessment, PGA) is a tool that provided a subjective evaluation of the overall severity of psoriasis using a 6-point ordinal scale ranging from “clear” to “very severe." The static IGA (sIGA) was used in this study and measured the Investigator’s impression of disease severity at a single time-point.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
|
|||||||||
End point title |
Change in Dermatology Life Quality Index (DLQI) after six weeks and twelve weeks of treatment, and four weeks after completion of treatment. | ||||||||
End point description |
Subjects were to answer 10 questions considering their Quality of Life (QoL) during the previous week on a 4-point scale. The total DLQI score represent the sum of the scores for each question, and ranges from 0 to 30, with higher scores reflecting worse QoL.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
|
||||||||
|
|||||||||
| Notes [4] - This endpoint was not analyzed due to early study termination based on lack of efficacy. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of subjects with adverse events (AEs) | ||||||||
End point description |
AEs were defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Week 20
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||
End point title |
Plasma Concentrations of RO5459072 | ||||||||||||||||||||||
End point description |
|||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||
End point timeframe |
Baseline (Day 1), Week 6 and Week 12
|
||||||||||||||||||||||
|
|||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Up to Week 20
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
RO5459072 100 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received two 50 mg capsules of RO5459072 (total of 100 mg) BID (total daily dose of 200 mg) for 12 weeks with or after food intake. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The study was terminated early because no efficacy was observed. | |||
