drugset / Trial / NCT02679105
Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy
Phase 2/3
Completed
38 enrolled
Karolinska Institutet
Karolinska University Hospital · collabSkane University Hospital · collabSodra Alvsborgs Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
Timeline
- Start
- 2015-05
- Primary completion
- 2016-10
- Completion
- 2019-03
Publications
- Results Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.
- Results Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056.
- Results Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available.
- Hellkvist L, Hjalmarsson E, Weinfeld D, Dahl A, Karlsson A, Westman M, Lundkvist K, Winqvist O, Georen SK, Westin U, Cardell LO. High-dose pollen intralymphatic immunotherapy: Two RDBPC trials question the benefit of dose increase. Allergy. 2022 Mar;77(3):883-896. doi: 10.1111/all.15042. Epub 2021 Aug 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ALK Alutard Birch | Unknown | 1000 unknown | Other |
| Comparator | ALK Alutard Birch | Unknown | 3000 unknown | Other |
| Comparator | ALK Alutard Birch | Unknown | 10000 unknown | Other |
| Comparator | ALK Alutard birch or 5-grasses | Unknown | 1000 unknown | Other |
| Comparator | ALK Alutard birch or 5-grasses | Unknown | 3000 unknown | Other |
| Comparator | ALK Alutard birch or 5-grasses | Unknown | 10000 unknown | Other |