Clinical Trial Results:
Safety and Effect of LEO 90100 aerosol foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) with Plaque Psoriasis
A phase 2 trial evaluating the safety and efficacy of once daily topical treatment with LEO 90100 aerosol foam in adolescent subjects with plaque psoriasis
An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis
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Summary
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EudraCT number |
2015-000839-33 |
Trial protocol |
NL PL |
Global end of trial date |
28 Mar 2018
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Results information
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Results version number |
v4(current) |
This version publication date |
30 Jan 2019
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First version publication date |
14 Oct 2018
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Other versions |
v1 , v2 , v3 |
Version creation reason |
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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 |
LP0053-1108
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02387853 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
LEO Pharma A/S
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Sponsor organisation address |
Industriparken 55, Ballerup, Denmark, 2750
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Public contact |
Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.com
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Scientific contact |
Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.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 |
22 Jun 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Mar 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Mar 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 is to evaluate the safety of once daily use of LEO 90100 in adolescent subjects (aged 12 to < 17 years) with plaque psoriasis on the body and scalp.
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Protection of trial subjects |
This clinical trial was conducted in accordance with the revision current at the start of the trial of the World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. All subjects received written and verbal information concerning the clinical trial. This information emphasised that participation in the clinical trial was voluntary and that the subject could withdraw from the clinical trial at any time and for any reason. All subjects and their legally acceptable representatives were given an opportunity to ask questions and were given sufficient time to consider before consenting. Subjects who were not of legal age gave assent to their participation in the trial. The subject’s and legally acceptable representatives' signed and dated informed consent and assent to participate in the clinical trial were obtained prior to any trial related activities being carried out in accordance with ICH Good Clinical Practice (GCP) Section 4.8 and all applicable laws and regulations.
Overdosage with calcipotriol may be associated with hypercalcaemia, and clinically important hypercalcaemia could be managed at the investigator’s discretion with rehydration, biphosphonate administration or according to local instructions.
Overdosage with betamethasone dipropionate may result in suppression of the pituitary adrenal function, and could be treated symptomatically at the investigator's discretion.
There is a risk of allergic hypersensitivity reactions with administration of Cortrosyn®/Synacthen®. Prior to the injection of Cortrosyn®/Synacthen®, the physician administering the injection was prepared to treat any possible hypersensitivity reactions.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Mar 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 |
Netherlands: 9
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Country: Number of subjects enrolled |
Poland: 71
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Country: Number of subjects enrolled |
Romania: 34
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Country: Number of subjects enrolled |
United States: 3
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Worldwide total number of subjects |
117
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EEA total number of subjects |
114
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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) |
117
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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 |
- | ||||||||||
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Pre-assignment
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Screening details |
Male/female 12-17 years, psoriasis on body and scalp Subj. not performing HPA axis test: Plaque psoriasis ≥2% BSA, ≥10% of scalp, ≥ mild severity Subj. performing HPA axis test: Plaque psoriasis ≥10% BSA, ≥20% of scalp, ≥ moderate severity, normal HPA-axis function 117 screened. 106 assigned to treatment, 8 screening failures, 3 withdrew consent | ||||||||||
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Period 1
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Period 1 title |
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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LEO 90100 | ||||||||||
Arm description |
This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
LEO 90100
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Investigational medicinal product code |
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Other name |
Enstilar®
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Pharmaceutical forms |
Cutaneous foam
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Routes of administration |
Topical use
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Dosage and administration details |
LEO 90100 is formulated as an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate). LEO 90100 was applied once daily to body and scalp psoriasis lesions. Subjects in the HPA axis cohort were to continue the treatment, even if their lesions had cleared at Week 2. Subjects in the non-HPA axis cohort were allowed to discontinue treatment if the psoriasis lesions had cleared at Week 2 (according to the investigator), but should stay in the trial. During periods of discontinuation of treatment, those cleared subjects were to restart treatment if the psoriasis re-appeared.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: The worldwide number of enrolled subjects include all subjects who provided consent for participation in the trial and were screened. Out of the 117 subjects who were screened, 106 subjects met all inclusion criteria and none of the exclusion criteria, and were assigned to treatment. These 106 subjects are subjects are included in the data for the baseline period. |
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full analysis set
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects assigned to treatment are included in the full analysis set and were analysed for efficacy. 106 subjects were assigned to the treatment. Thus the full analysis set consists of 106 subjects.
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Subject analysis set title |
Safety analysis set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The safety analysis set is defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. 106 subjects were assigned to treatment and had safety information collected. For 1 subject it was unknown whether any IMP was applied, but since it could neither be confirmed nor denied that the subject did not apply IMP, this subject was included in the safety analysis set. Therefore, the safety analysis set comprised 106 subjects.
The analysis of the results from the ACTH-challenge test is based on the per protocol analysis set and not on the safety analysis set.
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Subject analysis set title |
Per protocol analysis set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
For the analysis of the results from the ACTH-challenge test, a per protocol analysis set was defined by including subjects undergoing HPA axis assessments from the full analysis set, however excluding the subjects who:
• Received no treatment with the IMP
• Provided no results for the ACTH-challenge test at Week 4
• And/or do not fulfil inclusion criterion 17 concerning evidence of normal adrenal function at baseline: Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge).
A total of 34 subjects in the full analysis set were assigned to perform the ACTH challenge test. 33 subjects provided data for the ACTH-challenge, thus the per protocol analysis set comprises 33 subjects.
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Subject analysis set title |
24-hour urine HPA set
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
24-hour urine samples were only collected from subjects in the HPA axis cohort. All 34 subjects in the HPA axis cohort were included in this analysis set, referred to as the ‘24-hour urine HPA set’.
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Subject analysis set title |
Spot urine non-HPA set
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Some analytes in the spot urine samples (calcium, phosphate, and creatinine) were only to be measured in subjects in the non-HPA axis cohort. This analysis set is called ‘spot urine non-HPA set’ and comprised 72 subjects.
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End points reporting groups
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Reporting group title |
LEO 90100
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Reporting group description |
This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set. | ||
Subject analysis set title |
Full analysis set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects assigned to treatment are included in the full analysis set and were analysed for efficacy. 106 subjects were assigned to the treatment. Thus the full analysis set consists of 106 subjects.
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Subject analysis set title |
Safety analysis set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety analysis set is defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. 106 subjects were assigned to treatment and had safety information collected. For 1 subject it was unknown whether any IMP was applied, but since it could neither be confirmed nor denied that the subject did not apply IMP, this subject was included in the safety analysis set. Therefore, the safety analysis set comprised 106 subjects.
The analysis of the results from the ACTH-challenge test is based on the per protocol analysis set and not on the safety analysis set.
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Subject analysis set title |
Per protocol analysis set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
For the analysis of the results from the ACTH-challenge test, a per protocol analysis set was defined by including subjects undergoing HPA axis assessments from the full analysis set, however excluding the subjects who:
• Received no treatment with the IMP
• Provided no results for the ACTH-challenge test at Week 4
• And/or do not fulfil inclusion criterion 17 concerning evidence of normal adrenal function at baseline: Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge).
A total of 34 subjects in the full analysis set were assigned to perform the ACTH challenge test. 33 subjects provided data for the ACTH-challenge, thus the per protocol analysis set comprises 33 subjects.
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Subject analysis set title |
24-hour urine HPA set
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
24-hour urine samples were only collected from subjects in the HPA axis cohort. All 34 subjects in the HPA axis cohort were included in this analysis set, referred to as the ‘24-hour urine HPA set’.
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Subject analysis set title |
Spot urine non-HPA set
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Some analytes in the spot urine samples (calcium, phosphate, and creatinine) were only to be measured in subjects in the non-HPA axis cohort. This analysis set is called ‘spot urine non-HPA set’ and comprised 72 subjects.
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End point title |
Number of Subjects with Adverse Events (AEs) [1] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
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End point type |
Primary
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End point timeframe |
From Week -1 to Week 8
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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 is required for this end point. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 [2] | ||||||||||
End point description |
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
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End point type |
Primary
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End point timeframe |
30 minutes after ACTH-challenge at Week 4
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| Notes [2] - 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 is required for this end point. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change in albumin-corrected serum calcium from baseline to Week 4 [3] | ||||||||
End point description |
Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
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End point type |
Primary
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End point timeframe |
From baseline to Week 4
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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 statistical analysis is required for this end point. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change in calcium excretion in 24-hour urine from baseline to Week 4 [4] | ||||||||
End point description |
Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
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End point type |
Primary
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End point timeframe |
From baseline to Week 4
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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 statistical analysis is required for this end point. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change in calcium:creatinine ratio in 24-hour urine from baseline to Week 4 [5] | ||||||||
End point description |
Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
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End point type |
Primary
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End point timeframe |
From baseline to Week 4
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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 statistical analysis is required for this end point. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 | ||||||||||
End point description |
Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of adrenal function at baseline.
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End point type |
Secondary
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End point timeframe |
30 and 60 minutes after ACTH-challenge at Week 4
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 | ||||||||
End point description |
Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing.
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End point type |
Secondary
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End point timeframe |
From baseline to Week 4
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on body | ||||||||||
End point description |
Number of subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
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End point type |
Secondary
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End point timeframe |
Week 4
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| Notes [6] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on scalp | ||||||||||
End point description |
Number of subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
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End point type |
Secondary
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End point timeframe |
Week 4
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| Notes [7] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Percentage change in PASI from baseline to Week 4 | ||||||||
End point description |
Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.
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End point type |
Secondary
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End point timeframe |
From baseline to Week 4
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| Notes [8] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the body at Week 4 | ||||||||||
End point description |
Number of subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
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End point type |
Secondary
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End point timeframe |
Week 4
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| Notes [9] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Subjects With ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the scalp at Week 4 | ||||||||||
End point description |
Number of subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
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End point type |
Secondary
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End point timeframe |
Week 4
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| Notes [10] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 | ||||||||
End point description |
Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome.
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End point type |
Secondary
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End point timeframe |
From baseline to Week 4
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| Notes [11] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis |
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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 Day -28 up to Day 56
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Adverse event reporting additional description |
AEs/SAEs were followed up until final outcome was determined. After a subject left the trial, investigator followed up all SAEs and AEs deemed possibly/probably related to IMP for 14± 2 days or until final outcome was determined, whichever came first.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
This arm contains all 106 subjects that were assigned to treatment and constitutes the safety analysis set. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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08 Jul 2015 |
The amendment was triggered by comments received from the FDA.
- Local safety and tolerability assessment was added.
- The use of Synacthen® was added (European sites only)
- It was specified that subjects in the HPA axis cohort should continue their treatment even if their lesions had cleared at Week 2.
- A physical examination was added at Week 4 and at early withdrawal.
- Vital signs were added at baseline and Week 2
- Temperature (oral or ear) was added to vital signs.
- The PGA scale (Table 12) was updated to also include levels 0 (clear) and 1 (almost clear). |
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18 Jan 2016 |
This amendment was made to correct several minor errors. The following other important changes were made:
- It was specified that Synacthen® was provided to the sites in Poland and Romania.
- It was specified that cortisol was to be measured at SV2 and Week 4. |
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14 Mar 2016 |
This amendment was made to correct some minor errors. |
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29 Aug 2016 |
This amendment was made to correct an error, namely that serum cortisol analysis was mandated for all subjects. This measurement was only required for subjects in the HPA axis cohort. The following other important changes were made:
- A separate schedule of trial procedures was added for subjects in the non-HPA axis cohort.
- It was specified that LEO 90100 has different storage conditions in EU and the US (according to approved label). |
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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. | |||
| None reported | |||
