A trial to see if anti-IgE (an antibody) will improve severe eczema that has not been cured by other types of medicine

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-020841-29-GB
• Lead Sponsor: King`s College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-06
• Study Completion: 2017-08-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 62

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified