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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2010-020841-29-GB |
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Date of registration:
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06/04/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A trial to see if anti-IgE (an antibody) will improve severe eczema that has not been cured by other types of medicine
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Scientific title:
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The role of anti-IgE (omalizumab) in the management of severe
recalcitrant paediatric atopic eczema
- Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT) |
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Date of first enrolment:
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07/07/2011 |
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Target sample size:
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62 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020841-29 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Susan Chan
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Address:
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St Thomas' Hospital
SE1 7EH
Westminster Bride Raod, London
United Kingdom |
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Telephone:
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+4402071889730 |
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Email:
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susan.chan@kcl.ac.uk |
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Affiliation:
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Guy`s & St Thomas` NHS Foundation Trust |
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Name:
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Susan Chan
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Address:
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St Thomas' Hospital
SE1 7EH
Westminster Bride Raod, London
United Kingdom |
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Telephone:
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+4402071889730 |
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Email:
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susan.chan@kcl.ac.uk |
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Affiliation:
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Guy`s & St Thomas` NHS Foundation Trust |
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Key inclusion & exclusion criteria
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Inclusion criteria:
The inclusion criteria for run-in are:
1. Children between the ages of 4-19 years at the time of enrolment
2. Severe eczema with
i.an objective SCORAD (a validated eczema severity score) of over 40
ii.in a patient unresponsive to optimal topical therapy (potent topical
steroids and topical calcineurin inhibitors) or systemic therapy.
iii.in whom there is no impression of lack of compliance
iv.with a (C)DLQI score of =10
v.and in whom active skin infection has been ruled out and/or adequately
treated
3. Raised SpIgE (>0.35 IU/ml)or SPT (>3mm)to at least 1 food allergen
or 1 aeroallergen
AND/OR
4. Clinical impression that allergic exposures cause worsening eczema.
5. Total IgE level >300 kU/l.
6. Clinically proven IgE-mediated allergic disease including at least 1 of
the following:
i) immediate hypersensitivity to a food as proven by raised specific
IgE (SpIgE) or skin prick test (SPT) greater than the 95% positive
predictive value or =8mm, or a positive double blind placebo controlled
food challenge,
ii) allergic rhinoconjunctivitis as defined by sensitisation to a
respiratory allergen and clinical history of rhinoconjunctivitis symptoms
when exposed to the relevant allergen
iii) allergic asthma: a history of cough, wheeze, or shortness of breath
that
(1) was responsive to therapy with bronchodilators on two or
more occasions in the previous 24 months,
(2) required one visit to a physician in the previous 24 months,
and
(3) occurred during the night, during early morning, or upon
exercising in the intervals between exacerbations at any time in the
previous 12 months and
(4) where allergic exacerbations can be clinically related to an
allergen exposure WITH a corresponding positive SPT or SpIgE to
allergen.
7. Written informed consent to participate.
Are the trial subjects under 18? yes
Number of subjects for this age range: 62
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Children and/or families who are unable to comply with the regime of
2-4 weekly injections and clinic visits
2. Evidence of underlying immune compromise, autioimmune disease,
immune complex mediated conditions.
3. Malignancy or a history of malignancy.
4. Known cardiovascular or ischaemic cerebrovascular abnormality.
5 Other serious or uncontrolled systemic disease.
6. Pregnancy or lactation.
7. Known history of hypersensitivity or anaphylaxis to anti-IgE injections
or its constituents.
8. Insufficient understanding of the trial assessments.
9. Participation in a CTIMP in the previous 60 days or (if known) 4 halflives
of the relevant medication, whichever is the greater. In this case,
entry may be delayed until the appropriate time.
10. Investigator feels that there is a good clinical reason why the child
would be unsuitable to participate in the study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Severe eczema in children
MedDRA version: 19.0
Level: LLT
Classification code 10003641
Term: Atopic eczema
System Organ Class: 100000004858
MedDRA version: 19.0
Level: LLT
Classification code 10014189
Term: Eczema allergic atopic
System Organ Class: 100000004858
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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Trade Name: Xolair
Product Name: Omalizumab (Xolair)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Omalizumab
CAS Number: 242138-07-4
Other descriptive name: Xolair
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 24 weeks
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Secondary Objective: Primary outcome measure
1.Eczema severity:assessed by validated eczema score,objective SCORAD after 24 weeks treatment.
Secondary outcome
1.Treatment failure: patients who after 12 weeks treatment have persistent severe eczema despite 2 courses of rescue therapy
2.Alternative systemic therapy: patients in whom
a)alternative systemic therapy has started as a result of treatment
failure(defined above)
OR
b)alternative systemic therapy is started after 12 weeks and by 30 weeks.
3.Eczema quality of life by questionnaire
4.Eczema severity: objective & subjective SCORAD & EASI assessments, measurements of TEWL & medical photography
5.Effect on co-existing allergic disease by questionnaire(PADQLQ)
6.Adverse events
7.Number of eczema exacerbations
8.Infective episodes of eczema
9 a)Change in free total IgE and allergen specific IgE
b)the change in reactivity to food and aeroallergens
10. Change in use of potent topical steriods &calcineurin inhibitors
11.Mechanism action of anti-IgE
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Main Objective: Our hypothesis is that anti-IgE is associated with an improvement in eczema severity, compared to placebo.
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Primary end point(s): SCORAD (objective eczema severity score) at the end of 24 weeks of treatment with anti-IgE or placebo.
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Secondary Outcome(s)
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Secondary end point(s): 1. Treatment failure: patients who, after the 1st 12 weeks of treatment, have persistent severe eczema despite 2 courses of rescue therapy (0.5 to 1mg/kg/day of oral prednisolone for a week at a maximum dose of 40mg/day, followed by a week at 50% of this dose)
2. Alternative systemic therapy: in patients whom:
a) alternative systemic therapy has been started as a result of treatment failure as defined above, or
b) where alternative systemic therapy is started after 12 weeks and by 30 weeks.
3. Eczema quality of life: by questionnaire: POEM, (C)DLQI
4. Eczema severity by objective and subjective SCORAD and EASI (Eczema Area
and Severity Index) assessments, measurements of transepidermal water loss (TEWL) and
medical photography.
5. Effect on co-existing allergic disease by questionnaire (PADQLQ)
6. Adverse events: by history and investigations
7. Number of eczema exacerbations
8. Infective episodes of eczema
9 a) Change in free total IgE and allergen specific IgE
b) the change in reactivity to food and aeroallergens: by skin prick tests.
10. Change in use of potent topical steroids and calcineurin inhibitors: the weight, extent
and frequency of use will be recorded at each visit.
11. Mechanism of action of anti-IgE (this study will enable us to store the samples required
to study the immunohistochemical changes and the immunomodulatory effects on allergenspecific
T cells and FAP. There will also be an option to store blood for genetic studies.)
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Timepoint(s) of evaluation of this end point: 1. All visits
2. All visits
3. 0, 4, 8, 12, 16, 20, 24, 28, 36 and 48 weeks
4. SCORAD and EASI assessments will be used to examine eczema severity before and during treatment, and at 36 and 48 week post treatment reviews. Optional Measurements of transepidermal water loss (TEWL) will be performed at baseline, and at 24, 36 and 48 week (post treatment) reviews. Medical photography will also be used to record the condition of eczema at baseline and after 24 weeks of treatment.
5. 0, 16, 28, 36, 48 weeks
6. Throughout trial
7. At each visit
8. At each visit
9. 0, 24 weeks
10. At each visit
11. 0, 24 weeks
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Secondary ID(s)
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ADAPT
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ISRCTN15090567
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Source(s) of Monetary Support
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Guy's and St Thomas' charity
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Ethics review
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Status: Approved
Approval date:
Contact:
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