Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
Study NCT ID:
NCT04210193
Status:
COMPLETED
Last Update Posted:
2019-12-24
First Post:
2019-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is Intralymphatic Allergen Immunotherapy Effective and Safe?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075462', 'term': 'Serum Albumin, Human'}], 'ancestors': [{'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2019-12-17', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the serum-level of timothy specific IgG4 after 1 month', 'timeFrame': 'Change between baseline and 1 month after treatment.', 'description': 'Blood samples with measurement of allergen specific blocking IgG4 antibodies'}, {'measure': 'Change in the serum-level of timothy specific IgG4 after 9 months', 'timeFrame': 'Change between baseline and 9 months after treatment.', 'description': 'Blood samples with measurement of allergen specific blocking IgG4 antibodies'}, {'measure': 'Change in the serum-level of timothy specific IgG4 2 months after booster', 'timeFrame': 'Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).', 'description': 'Blood samples with measurement of allergen specific blocking IgG4 antibodies'}, {'measure': 'Change in the serum-level of timothy specific IgG4 10 months after booster', 'timeFrame': 'Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).', 'description': 'Blood samples with measurement of allergen specific blocking IgG4 antibodies'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis Due to Grass Pollen']}, 'referencesModule': {'references': [{'pmid': '26817454', 'type': 'BACKGROUND', 'citation': 'Hylander T, Larsson O, Petersson-Westin U, Eriksson M, Kumlien Georen S, Winqvist O, Cardell LO. Intralymphatic immunotherapy of pollen-induced rhinoconjunctivitis: a double-blind placebo-controlled trial. Respir Res. 2016 Jan 27;17:10. doi: 10.1186/s12931-016-0324-9.'}, {'pmid': '31775016', 'type': 'BACKGROUND', 'citation': 'Konradsen JR, Grundstrom J, Hellkvist L, Tran TAT, Andersson N, Gafvelin G, Kiewiet MBG, Hamsten C, Tang J, Parkin RV, Shamji MH, Hedlin G, Cardell LO, van Hage M. Intralymphatic immunotherapy in pollen-allergic young adults with rhinoconjunctivitis and mild asthma: A randomized trial. J Allergy Clin Immunol. 2020 Mar;145(3):1005-1007.e7. doi: 10.1016/j.jaci.2019.11.017. Epub 2019 Nov 24. No abstract available.'}, {'pmid': '32368217', 'type': 'DERIVED', 'citation': 'Weinfeld D, Westin U, Hellkvist L, Mellqvist UH, Jacobsson I, Cardell LO. A preseason booster prolongs the increase of allergen specific IgG4 levels, after basic allergen intralymphatic immunotherapy, against grass pollen seasonal allergy. Allergy Asthma Clin Immunol. 2020 Apr 28;16:31. doi: 10.1186/s13223-020-00427-z. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': '15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.', 'detailedDescription': 'The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.\n\nThe aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.\n\nThe first part of the study is completed and published (PMID: 23374268)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-50,\n* Seasonal allergic symptoms for birch and/or grass verified by skin prick test,\n* Accepted informed consent\n\nExclusion Criteria:\n\n* Pregnancy or nursing\n* Autoimmune or collagen disease (known)\n* Cardiovascular disease\n* Perennial pulmonary disease\n* Hepatic disease\n* Renal disease\n* Cancer\n* Any medication with a possible side-effect of interfering with the immune response\n* Previous immuno- or chemotherapy\n* Chronic diseases\n* Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)\n* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)\n* Major metabolic disease\n* Known or suspected allergy to the study product\n* Alcohol or drug abuse\n* Mental incapability of coping with the study\n* Withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT04210193', 'briefTitle': 'Is Intralymphatic Allergen Immunotherapy Effective and Safe?', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster', 'orgStudyIdInfo': {'id': 'ILIT Borås EPN 2014/251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active booster', 'description': 'After three basic open label grass allergen ILIT injections the patient is randomized to an active ILIT booster 1 year after the first treatment.', 'interventionNames': ['Drug: ALK Alutard 5-grasses']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo booster', 'description': 'After three basic open label grass allergen ILIT injections the patient is randomized to a placebo ILIT booster 1 year after the first treatment.', 'interventionNames': ['Drug: ALK Diluent']}], 'interventions': [{'name': 'ALK Alutard 5-grasses', 'type': 'DRUG', 'otherNames': ['Grass allergen with aluminum adjuvant'], 'description': '0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection', 'armGroupLabels': ['Active booster']}, {'name': 'ALK Diluent', 'type': 'DRUG', 'otherNames': ['Human albumin'], 'description': '0.1 mL of ALK Diluent as an intralymphatic injection', 'armGroupLabels': ['Placebo booster']}]}, 'contactsLocationsModule': {'locations': [{'zip': '501 82', 'city': 'Borås', 'country': 'Sweden', 'facility': 'Allergy Unit, Södra Älvsborgs Hospital', 'geoPoint': {'lat': 57.72101, 'lon': 12.9401}}], 'overallOfficials': [{'name': 'Lars Olaf Cardell, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Olaf Cardell', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lars Olaf Cardell', 'investigatorAffiliation': 'Karolinska Institutet'}}}}