Clinical Trial Results:
Pilot trial to determine the efficacy of secukinumab in active non-segmental vitiligo
Summary
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EudraCT number |
2015-003552-48 |
Trial protocol |
BE |
Global end of trial date |
16 Jan 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jun 2024
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First version publication date |
06 Jun 2024
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Other versions |
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Summary report(s) |
Final Study Report |
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 |
AGO/2015/009
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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 |
Ghent University Hospital
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Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
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Public contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
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Scientific contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
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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 |
22 Feb 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Jan 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jan 2018
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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 |
The primary objective of this study is to investigate the capacity of a targeted anti-IL-17A treatment with secukinumab to induce repigmentation in vitiligo patients with active disease.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Oct 2016
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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 |
Belgium: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
8
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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) |
7
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
8 patients were recruited between 12-Oct-2016 and 16-Dec-2017. End of trial notification was dated 16-Dec-2017(last patient last visit) and submitted to EC and CA on 13-Feb-2018. There were 3 dropouts due to disease progression (for 2 patients) and unexpected stay abroad (for 1 patient). | ||||||||||||||||||
Pre-assignment
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Screening details |
Main inclusion criteria: 1) Moderate to extensive vitiligo (body surface area ≥ 3%) 2) Vitiligo patients with ‘active vitiligo’. 3) Vitiligo on hands and/or face 4) Fitzpatrick skin type 3-6 5) Impact score > 8/10 or DLQI (Dermatology Life Quality Index) > Patients were included correctly | ||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
Blinding implementation details |
No blinding done, all patients have received the active compound
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Baseline data | ||||||||||||||||||
Arm description |
Baseline data for the study, as the study only has 1 arm | ||||||||||||||||||
Arm type |
Baseline arm | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Active arm | ||||||||||||||||||
Arm description |
Arm receiving the active product (only one arm in the study) | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Secukinumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Injections with secukinumab (300 mg) will be performed. The injections will be given at baseline, week 1, 2, 3, 4 and subsequent injections will be administered every 4 weeks (total of 10 injections).
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline data
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Reporting group description |
Baseline data for the study, as the study only has 1 arm | ||
Reporting group title |
Active arm
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Reporting group description |
Arm receiving the active product (only one arm in the study) |
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End point title |
Repigmentation [1] [2] | ||||||||||
End point description |
The primary endpoint (repigmentation) was not reached.
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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 statistical analysis available. The endpoint was not reached. See attachement Final Study Report [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The end point is not reported for the baseline arm. The baseline arm for the study was added as the study only has 1 arm. See attachement Final Study Report |
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No statistical analyses for this end point |
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End point title |
Improvement in Global Satisfaction [3] [4] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Score using the Likert scale (5 points)
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Notes [3] - 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: See attachement Final Study Report [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The end point is not reported for the baseline arm. The baseline arm for the study was added as the study only has 1 arm. See attachement Final Study Report |
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No statistical analyses for this end point |
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End point title |
Disease stability (stop of progression) [5] | ||||||||||
End point description |
The secondary endpoint (disease stability) was not reached.
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End point type |
Secondary
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End point timeframe |
N/A
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Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The end point is not reported for the baseline arm. The baseline arm for the study was added as the study only has 1 arm. See attachement Final Study Report |
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No statistical analyses for this end point |
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End point title |
Improvement in Dermatology Life Quality Index [6] | ||||||
End point description |
In none of the patients clear clinical efficacy was noted.
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End point type |
Secondary
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End point timeframe |
N/A
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Notes [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: See attachement Final Study Report |
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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 |
Adverse events will be reported between the first dose administration of trial medication and the last trial related activity
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
Baseline data
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Reporting group description |
Baseline data for the study, as the study only has 1 arm | |||||||||||||||
Reporting group title |
Active arm
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Reporting group description |
Arm receiving the active product (only one arm in the study) | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||
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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 adverse events occurred during the study. See attachement Final Study Report |
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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. | |||
None reported |