Clinical Trials Logo
  1. Home
  2. Atopic Dermatitis
  3. NCT02300701
  4. Details
NCT02300701 Clinical Trial

Role of Anti-IgE in Severe Childhood Eczema

Atopic Dermatitis Clinical Trial

— ADAPT  

Official title:
The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02300701
Other study ID # ADAPT
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2014
Est. completion date August 2018

Study information
Verified date August 2019
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 4 Years to 19 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xolair
According to manufacturer's instructions
• Placebo
Placebo

Locations
Country Name City State
United Kingdom Guy's and St Thomas' NHS Foundation Trust London

Sponsors (3)
Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust King's College London, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in atopic eczema 24 weeks after treatment commences
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2