NCT02300701

Brief Summary

To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

3.7 years

First QC Date

November 21, 2014

Last Update Submit

August 8, 2019

Conditions

Atopic EczemaAtopic DermatitisChild

Outcome Measures

Primary Outcomes (1)

  • Improvement in atopic eczema

    24 weeks after treatment commences

Study Arms (2)

Xolair/Omalizumab

EXPERIMENTAL
Drug: Xolair

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

XolairDRUG

According to manufacturer's instructions

Also known as: Omalizumab
Xolair/Omalizumab
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age4 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 31764962DERIVED

  • Chan 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.

    PMID: 28330497DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • S Chan, MBBS, MD

    Guy's and St Thomas' Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 25, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

GB(1)