Clinical Trials Register

Summary
EudraCT Number:	2010-020841-29
Sponsor's Protocol Code Number:	ADAPT
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-04-06
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2010-020841-29

A.3

Full title of the trial

The role of anti-IgE (omalizumab) in the management of severe
recalcitrant paediatric atopic eczema

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.3.2

Name or abbreviated title of the trial where available

Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT)

A.4.1

Sponsor's protocol code number

ADAPT

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN15090567

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	King`s College London
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Guy's and St Thomas' charity
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Guy`s & St Thomas` NHS Foundation Trust
B.5.2	Functional name of contact point	Susan Chan
B.5.3	Address:
B.5.3.1	Street Address	St Thomas' Hospital
B.5.3.2	Town/ city	Westminster Bride Raod, London
B.5.3.3	Post code	SE1 7EH
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+4402071889730
B.5.5	Fax number	+4402071889782
B.5.6	E-mail	susan.chan@kcl.ac.uk
B.Sponsor: 2
B.1.1	Name of Sponsor	Guy`s & St Thomas` NHS Foundation Trust
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Guy's and St Thomas' Charity
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Guy`s & St Thomas` NHS Foundation Trust
B.5.2	Functional name of contact point	Dr Susan Chan
B.5.3	Address:
B.5.3.1	Street Address	St Thomas' Hospital
B.5.3.2	Town/ city	Westminster Bridge Road, London
B.5.3.3	Post code	SE1 7EH
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+4402071889730
B.5.5	Fax number	+4402071889782
B.5.6	E-mail	susan.chan@kcl.ac.uk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Xolair
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Omalizumab (Xolair)
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Omalizumab
D.3.9.1	CAS number	242138-07-4
D.3.9.3	Other descriptive name	Xolair
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Severe eczema in children

E.1.1.1

Medical condition in easily understood language

Severe eczema in children

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10003641
E.1.2	Term	Atopic eczema
E.1.2	System Organ Class	100000004858

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10014189
E.1.2	Term	Eczema allergic atopic
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Our hypothesis is that anti-IgE is associated with an improvement in eczema severity, compared to placebo.

E.2.2

Secondary objectives of the trial

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

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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.

E.5 End points

E.5.1

Primary end point(s)

SCORAD (objective eczema severity score) at the end of 24 weeks of treatment with anti-IgE or placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks

E.5.2

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.)

E.5.2.1

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

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit of the last patient

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

subjects under age incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

local NHS treatment will be sought.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-08-31

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