Atopic EczemaPhase 4ADAPTNCT02300701
Role of Anti-IgE in Severe Childhood Eczema
A Phase 4 study testing Xolair in people with Atopic Eczema and Atopic Dermatitis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema. Read more about this study
- Who is it for?
- Ages 4 to 19 years
- Conditions the study is for
- Atopic Eczema, Atopic Dermatitis, Child
- What is being tested?
- Xolair
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between the ages of 4-19 years
- Severe eczema
- Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
- Clinical impression that allergic exposures cause worsening eczema.
- Total IgE level >300 kU/l
- Clinically proven IgE-mediated allergic disease.
- Written informed consent to participate.
Who cannot join
- Inability to comply with 2-4 weekly injections and clinic visits
- Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
- Uncontrolled infection or unstable eczema.
- Malignancy or a history of malignancy.
- Pre-existing hepatic or renal impairment
- Known cardiovascular or ischaemic cerebrovascular abnormality.
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- Other serious or uncontrolled systemic disease.
- Pregnancy or lactation.
- Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
- Insufficient understanding of the trial assessments.
- Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
- Investigator feels that there is a good clinical reason why the child would be unsuitable.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.
Read the detailed description
To address the value of anti-IgE in children with severe eczema.
- Conditions
- Atopic Eczema, Atopic Dermatitis, Child
- Being tested
- Xolair, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XolairDrug
Also called Omalizumab
According to manufacturer's instructions
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Xolair/Omalizumab | Experimental | Not described Receives: Drug: Xolair |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in atopic eczema
Measured: 24 weeks after treatment commences
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic EczemaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- S Chan, MBBS, MD, Principal investigator, Guy's and St Thomas' Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300701
- Sponsor's protocol ID
- ADAPT
- Acronym
- ADAPT
- Status last verified
- Aug 2019
- First submitted
- 21 Nov 2014
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan S, Cornelius V, Cro S, Harper JI, Lack G. Treatment Effect of Omalizumab on Severe Pediatric Atopic Dermatitis: The ADAPT Randomized Clinical Trial. JAMA Pediatr. 2020 Jan 1;174(1):29-37. doi: 10.1001/jamapediatrics.2019.4476.
PubMed 31764962Chan S, Cornelius V, Chen T, Radulovic S, Wan M, Jahan R, Lack G. Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial. Trials. 2017 Mar 22;18(1):136. doi: 10.1186/s13063-017-1809-7.
PubMed 28330497
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
- ClinicalTrials.gov ID
- NCT02300701
- Acronym / sponsor ID
- ADAPT / ADAPT
- Conditions
- Atopic Eczema, Atopic Dermatitis, Child
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, National Institute for Health Research, United Kingdom
- Study start
- Dec 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.
Detailed description
To address the value of anti-IgE in children with severe eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xolair/Omalizumab | Experimental | Drug: Xolair |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 4 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children between the ages of 4-19 years
- Severe eczema
- Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
- Clinical impression that allergic exposures cause worsening eczema.
- Total IgE level >300 kU/l
Key exclusion criteria (12 listed)
- Inability to comply with 2-4 weekly injections and clinic visits
- Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
- Uncontrolled infection or unstable eczema.
- Malignancy or a history of malignancy.
- Pre-existing hepatic or renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XolairAlso: OmalizumabAccording to manufacturer's instructions | Drug | Xolair/Omalizumab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Improvement in atopic eczema
Time frame: 24 weeks after treatment commences
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Derived from this study: PubMed 31764962Chan S, Cornelius V, Cro S, Harper JI, Lack G. Treatment Effect of Omalizumab on Severe Pediatric Atopic Dermatitis: The ADAPT Randomized Clinical Trial. JAMA Pediatr. 2020 Jan 1;174(1):29-37. doi: 10.1001/jamapediatrics.2019.4476.
- Derived from this study: PubMed 28330497Chan S, Cornelius V, Chen T, Radulovic S, Wan M, Jahan R, Lack G. Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial. Trials. 2017 Mar 22;18(1):136. doi: 10.1186/s13063-017-1809-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S Chan, MBBS, MD principal investigator
Guy's and St Thomas' Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xolair in people with Atopic Eczema and Atopic Dermatitis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in atopic eczema (time frame: 24 weeks after treatment commences). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02300701, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.