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Role of Anti-IgE in Severe Childhood Eczema (ADAPT)

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ClinicalTrials.gov Identifier: NCT02300701
Recruitment Status : Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : February 15, 2018
Sponsor:
Collaborators:
King's College London
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE November 21, 2014
First Posted Date  ICMJE November 25, 2014
Last Update Posted Date February 15, 2018
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
Improvement in atopic eczema [ Time Frame: 24 weeks after treatment commences ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02300701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Anti-IgE in Severe Childhood Eczema
Official Title  ICMJE The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Atopic Eczema
  • Atopic Dermatitis
  • Child
Intervention  ICMJE
  • Drug: Xolair
    According to manufacturer's instructions
    Other Name: Omalizumab
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Xolair/Omalizumab
    Intervention: Drug: Xolair
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2014)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Children between the ages of 4-19 years
  2. Severe eczema
  3. Raised SpIgE or SPT 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.
  7. Written informed consent to participate.

Exclusion criteria:

  1. Inability to comply with 2-4 weekly injections and clinic visits
  2. Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
  3. Uncontrolled infection or unstable eczema.
  4. Malignancy or a history of malignancy.
  5. Pre-existing hepatic or renal impairment
  6. Known cardiovascular or ischaemic cerebrovascular abnormality.
  7. Other serious or uncontrolled systemic disease.
  8. Pregnancy or lactation.
  9. Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
  10. Insufficient understanding of the trial assessments.
  11. Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
  12. Investigator feels that there is a good clinical reason why the child would be unsuitable.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300701
Other Study ID Numbers  ICMJE ADAPT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor  ICMJE Guy's and St Thomas' NHS Foundation Trust
Collaborators  ICMJE
  • King's College London
  • National Institute for Health Research, United Kingdom
Investigators  ICMJE
Principal Investigator: S Chan, MBBS, MD Guy's and St Thomas' Hospitals NHS Foundation Trust
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP