Clinical Trial Results:
A multicenter open label uncontrolled study of the long term safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 26 weeks in pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis
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Summary
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EudraCT number |
2014-000710-53 |
Trial protocol |
DE IT BE HU |
Global end of trial date |
29 May 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Sep 2020
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First version publication date |
25 Sep 2020
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Other versions |
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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 |
RD.06.SPR.18131
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02125279 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GALDERMA R&D, SNC
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Sponsor organisation address |
Les Templiers, 2400 route des Colles, Biot, France, 06410
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Public contact |
CTA Coordinator, GALDERMA R&D, SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.com
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Scientific contact |
CTA Coordinator, GALDERMA R&D, SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.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 |
28 May 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 May 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
29 May 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 |
To evaluate the safety of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with plaque psoriasis.
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Protection of trial subjects |
This study was performed in compliance with Good Clinical Practice (GCP) including the archiving of essential study documents. All data provided either to the Investigator (and study staff) or collected during the study and/or reported herein should be regarded as confidential and proprietary in nature and should not be disclosed to any third party without the written consent of Galderma.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 May 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
1 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Canada: 11
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Country: Number of subjects enrolled |
United States: 32
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Country: Number of subjects enrolled |
Belgium: 2
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Country: Number of subjects enrolled |
Germany: 4
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Country: Number of subjects enrolled |
Italy: 5
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Worldwide total number of subjects |
54
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EEA total number of subjects |
11
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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) |
34
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Adolescents (12-17 years) |
20
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Adults (18-64 years) |
0
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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 |
The original intent of the study was to screen approximately 167 subjects in order to enroll a target of 100 subjects. However due to slow study enrollment and in agreement with the Food and Drug Administration, the study was closed to enrollment in November 2017. | ||||||||||||||||
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Pre-assignment
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Screening details |
A total of 88 subjects were screened. Only 54 subjects out of 88 were enrolled and received study drug, of which 41 subjects completed the study. | ||||||||||||||||
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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 | ||||||||||||||||
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Arms
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Arm title
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Calcitriol 3 mcg/g | ||||||||||||||||
Arm description |
Subjects received calcitriol 3 microgram per gram (mcg/g) ointment applied twice daily without exceeding a maximum of 0.5 gram per kilogram (g/kg) of body weight or 28 gram (g) daily (whichever was the lower) up to 26 weeks. Subjects were further followed up for 4 weeks. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Calcitriol
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Investigational medicinal product code |
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Other name |
CD2027
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Pharmaceutical forms |
Ointment
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Routes of administration |
Topical use
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Dosage and administration details |
Subjects applied calcitriol 3 microgram per gram (mcg/g) ointment applied twice daily up to 26 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
All enrolled subjects who have applied the study drug at least once during the study. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Calcitriol 3 mcg/g
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Reporting group description |
Subjects received calcitriol 3 microgram per gram (mcg/g) ointment applied twice daily without exceeding a maximum of 0.5 gram per kilogram (g/kg) of body weight or 28 gram (g) daily (whichever was the lower) up to 26 weeks. Subjects were further followed up for 4 weeks. | ||
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End point title |
Change From Screening in Serum Albumin Levels at Week 4 [1] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening and Week 4
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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 inferential statistical analysis was planned and performed for this endpoint. |
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| Notes [2] - Number of evaluable subjects for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Albumin Levels at Week 8 [3] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 8
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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: No inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Albumin Levels at Week 12 [4] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 12
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| Notes [4] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Albumin Levels at Week 20 [5] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 20
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| Notes [5] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Albumin Levels at Week 26 [6] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 26
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| Notes [6] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up) [7] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 30 (Follow-up)
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| Notes [7] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12 [8] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 12
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| Notes [8] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26 [9] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 26
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| Notes [9] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up) [10] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 30 (Follow-up)
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| Notes [10] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Phosphate Levels at Week 4 [11] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 4
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| Notes [11] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Phosphate Levels at Week 12 [12] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 12
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| Notes [12] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Phosphate Levels at Week 20 [13] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 20
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| Notes [13] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Phosphate Levels at Week 26 [14] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 26
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| Notes [14] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up) [15] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 30 (Follow-up)
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| Notes [15] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4 [16] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 4
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| Notes [16] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 8 [17] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 8
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| Notes [17] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 12 [18] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 12
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| Notes [18] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 20 [19] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 20
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| Notes [19] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 26 [20] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 26
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| Notes [20] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 30 (Follow-up) [21] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 30 (Follow-up)
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| Notes [21] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) [22] | ||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug. Safety population included as all the subjects who have applied the study drug at least once.
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End point type |
Primary
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End point timeframe |
Up to Week 30
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| Notes [22] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||
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End point title |
Change From Screening in Serum Phosphate Levels at Week 8 [23] | ||||||||
End point description |
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 8 were reported. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Screening, Week 8
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| Notes [23] - 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 inferential statistical analysis was planned and performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Investigator’s Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | ||||||||||||||||||
End point description |
The IGA is a 0 to 4 point scale. Where, 0 = clear (no signs of psoriasis except for residual hypopigmentation/hyperpigmentation); 1 = almost clear (just perceptible erythema, no induration, and no scaling); 2 = mild (mild erythema, no induration, and mild or no scaling); 3 = moderate (moderate erythema, mild induration, and mild or no scaling); 4 = severe (severe erythema, moderate to severe induration, and scaling of any degree). Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable this outcome measure and 'n' (number of subjects analyzed) signifies number of subjects evaluable for each time point.
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End point type |
Secondary
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End point timeframe |
Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change From Baseline in Pruritus Score at Each Visit | ||||||||||||||||||||
End point description |
Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' (overall number of subjects analyzed) signifies number of subjects evaluable this outcome measure and 'n' (number of subjects analyzed) signifies number of subjects evaluable for each time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | ||||||||||||||||||||
End point description |
Percent BSA was calculated by modified rules of nines (pediatric subjects). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back. Safety population included as all the subjects who have applied the study drug at least once. Here 'N' signifies number of subjects evaluable this outcome measure and 'n' signifies number of subjects evaluable for each time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
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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 |
From start of treatment up to follow up (30 weeks)
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Assessment type |
Systematic | ||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
Calcitriol 3 mcg/g
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Reporting group description |
Subjects received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Subjects were further followed up for 4 weeks. | ||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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28 Aug 2014 |
Amendment 1:
-Added Phase 3 designation for non-United States (US) regions
-Updated contact information for the assigned medical expert
-Added a 5-day time window to the baseline visit
-Modified the wording for rolling over subjects from Study 18132 (EudraCT number 2014-001744-38)
-Increased the rolling over period from 7 to 14 days
-Corrected error in how the Subject Identification Number was allocated
-Revised decision of performing 24-hour urine collection if calcium creatinine ratio was above normal range on a 4-hour fasting collection
-Added that female subjects who began menses after Screening would be abstinent for the duration of the study or remain abstinent for at least 1 month after first use of a contraceptive to allow the contraceptive method to be effective
-Added clarification of how to estimate BSA
-Made minor editorial changes and added equivalent wording according to other non-US regions |
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02 Dec 2015 |
Amendment 2:
-Added secondary objective of PK assessments in approximately 9 subjects aged 2 to 6 years and 11 months old with plaque psoriasis and a minimum of 3% BSA involvement, to fulfill FDA Phase 4 requirements
-Added serum PD assessment at Baseline for subjects in the PK group in order to investigate PK/PD relationships
-Changed the upper limit of age inclusion criterion from 17 years to 16 years 11 months at study start
-Reduced the number of enrolled subjects
-Removed requirement for equal distribution among age groups
-Added blood draws at every study visit for subset of subjects in the PK group
-Removed study visits at Week 8 and Week 20
-Removed text regarding subjects rolling over from Study 18132 (EudraCT number 2014-001744-38)
-Instructions for use of topical anesthetic creams
-Clarified the case management of PTH results that fell below the lower limit of normal
-Added clarification of timing and location of study drug application in relation to PK blood sampling |
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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 trial was stopped due to slow enrollment and in agreement with the FDA. Full enrollment was never met in the study. | |||
