{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T08:13:54Z","timestamp":1788164034716,"version":"build-2803163510"},"reference-count":34,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T00:00:00Z","timestamp":1788134400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T00:00:00Z","timestamp":1788134400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Experimental Allergy"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This paper reports a Phase 1, randomised, placebo\u2010controlled, dose\u2010escalation trial (NCT06037148) with DM\u2010101PX that contains a recombinant hypoallergenic Bet v 1 variant formulated with thermosensitive hydrogel. The objectives of the study included assessment of treatment\u2010related adverse events and the number of participants reaching the maximum dose. In addition, Bet v 1\u2010specific immunoglobulins were analysed to explore the immunological effects of treatment. The trial was funded by Desentum Oy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study included three cohorts differing in starting and maximum dose. Per cohort, subjects were randomised (4:1) to receive 10 weekly subcutaneous injections with DM\u2010101PX or placebo. Main inclusion criteria comprised adult subjects with a birch pollen allergy for \u2265\u20092\u2009years, positive skin prick test, birch pollen\u2010IgE \u2265\u20090.7 kU\/L and symptoms upon exposure to birch pollen. The randomisation schedule was generated using software. During the trial, the investigator, clinic staff, participants and sponsor remained blinded to the treatment groups. The primary endpoint was the occurrence of treatment emergent adverse events and adverse events of special interest.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In each cohort, 10 subjects were randomised and all were used for analysis of safety data. Treatment\u2010related adverse events were reported by 22\/24 (91.7%) DM\u2010101PX treated subjects and by 5\/6 (83.3%) placebo\u2010treated subjects, which were only of mild or moderate intensity. The DM\u2010101PX and placebo\u2010treated subjects had mainly local injection site reactions, 138\/153 (90.2%) and 22\/24 (91.2%), respectively. Fifteen systemic allergic reactions were reported by 5\/24 (20.8%) DM\u2010101PX\u2010treated subjects, and 2 systemic allergic reactions were reported by 1\/6 (16.7%) placebo\u2010treated subject, all of which were of Grade 1. 21\/24 (88%) of subjects reached the maximum dose. Treatment with DM\u2010101PX induced pronounced levels of Bet v 1\u2010specific IgG\n                      <jats:sub>4<\/jats:sub>\n                      and post\u2010treatment sera effectively blocked basophil activation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This small study demonstrated that DM\u2010101PX was generally well tolerated and induced a strong and functional immune response.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/cea.70424","type":"journal-article","created":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T07:16:57Z","timestamp":1788160617000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Subcutaneous Allergen Immunotherapy With Thermosensitive Hydrogel and Recombinant Birch Pollen Allergen Variant, a Randomised Controlled Trial"],"prefix":"10.1111","author":[{"given":"Anna","family":"Nilson","sequence":"first","affiliation":[{"name":"Desentum Oy  Espoo Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Couroux","sequence":"additional","affiliation":[{"name":"Cliantha Research  Mississauga Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-9800-6541","authenticated-orcid":false,"given":"Jaana","family":"Haka","sequence":"additional","affiliation":[{"name":"Desentum Oy  Espoo Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silja","family":"Halme","sequence":"additional","affiliation":[{"name":"Desentum Oy  Espoo Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8766-5138","authenticated-orcid":false,"given":"Pekka","family":"Mattila","sequence":"additional","affiliation":[{"name":"Desentum Oy  Espoo Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3991-5297","authenticated-orcid":false,"given":"R. 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Joost","family":"van Neerven","sequence":"additional","affiliation":[{"name":"Cell Biology and Immunology Wageningen University Research  Wageningen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-0447-9789","authenticated-orcid":false,"given":"Rolien","family":"Pels\u2010Rijcken","sequence":"additional","affiliation":[{"name":"Cell Biology and Immunology Wageningen University Research  Wageningen the Netherlands"},{"name":"Department of Clinical Chemistry and Haematology Rijnstate Hospital\/DICOON Laboratories  Arnhem the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1713-3841","authenticated-orcid":false,"given":"Janneke","family":"Ruinemans\u2010Koerts","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry and Haematology Rijnstate Hospital\/DICOON Laboratories  Arnhem the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yvonne","family":"Schmidt\u2010Hieltjes","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry and Haematology Rijnstate Hospital\/DICOON Laboratories  Arnhem the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Marie","family":"Salapatek","sequence":"additional","affiliation":[{"name":"Cliantha Research  Mississauga Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-1412-2430","authenticated-orcid":false,"given":"Kati","family":"Sallinen","sequence":"additional","affiliation":[{"name":"Desentum Oy  Espoo Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8592-1743","authenticated-orcid":false,"given":"Kristiina","family":"Takkinen","sequence":"additional","affiliation":[{"name":"Desentum Oy  Espoo Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daphne","family":"Tsitoura","sequence":"additional","affiliation":[{"name":"Imperial College  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk\u2010Jan","family":"Opstelten","sequence":"additional","affiliation":[{"name":"Desentum Oy  Espoo Finland"},{"name":"OLSC B.V.  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