Clinical Trial Results:
An open label phase 2a trial assessing the clinical effect and safety of RO5459072 in moderate to severe psoriasis.
Summary
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EudraCT number |
2018-002446-36 |
Trial protocol |
DE |
Global end of trial date |
25 Jun 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Jul 2020
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First version publication date |
08 Jul 2020
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Other versions |
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 |
BP40635
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche, Ltd.
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
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Public contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com
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Scientific contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche, Ltd., +41 616878333, genentech@druginfo.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 |
25 Jun 2019
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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 |
25 Jun 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the clinical effect of oral RO5459072 in adult subjects with moderate to severe psorisis.
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Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Dec 2018
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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 |
Germany: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
27
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||
Pre-assignment
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Screening details |
A total of 30 subjects were enrolled in the study. | ||||||||||||||
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 | ||||||||||||||
Arms
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Arm title
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RO5459072 100 mg | ||||||||||||||
Arm description |
- | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Petesicatib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Two 50 mg capsules of RO5459072 (total of 100 mg) BID (twice a day) for 12 weeks
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Baseline characteristics reporting groups
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Reporting group title |
RO5459072 100 mg
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
RO5459072 100 mg
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Reporting group description |
- |
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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.
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End point type |
Primary
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End point timeframe |
Week 12
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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 formal statistical analyses were performed as the study was terminated for futility. |
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Notes [2] - No patients achieved a PASI75 response after twelve weeks of treatment. |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
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Notes [3] - This endpoint was not analyzed due to early study termination based on lack of efficacy. |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment
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Notes [4] - This endpoint was not analyzed due to early study termination based on lack of efficacy. |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Up to Week 20
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No statistical analyses for this end point |
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End point title |
Plasma Concentrations of RO5459072 | ||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), Week 6 and Week 12
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to Week 20
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
RO5459072 100 mg
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
The study was terminated early because no efficacy was observed. |