drugset / Trial / NCT02300701
Role of Anti-IgE in Severe Childhood Eczema
Phase 4
Completed
62 enrolled
Guy's and St Thomas' NHS Foundation Trust
King's College London · collabNational Institute for Health Research, United Kingdom · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.
Timeline
- Start
- 2014-12
- Primary completion
- 2018-08
- Completion
- 2018-08
Outcome
Met primary endpoint
paper the mean difference in objective SCORAD index improvement between groups at week 24 was -6.9 (95% CI, -12.2 to -1.5; P = .01), significantly favoring omalizumab therapy PMID 31764962 ↗
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | — | Subcutaneous |