Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300701
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : August 9, 2019
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

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

Condition or disease Intervention/treatment Phase
Atopic Eczema Atopic Dermatitis Child Drug: Xolair Drug: Placebo Phase 4

Detailed Description:
To address the value of anti-IgE in children with severe eczema.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
Study Start Date : December 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: Xolair/Omalizumab Drug: Xolair
According to manufacturer's instructions
Other Name: Omalizumab

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Improvement in atopic eczema [ Time Frame: 24 weeks after treatment commences ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300701


Locations
Layout table for location information
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
National Institute for Health Research, United Kingdom
Investigators
Layout table for investigator information
Principal Investigator: S Chan, MBBS, MD Guy's and St Thomas' Hospitals NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02300701     History of Changes
Other Study ID Numbers: ADAPT
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents