Clinical trial • Phase II/III • Immunology

Colecalciferol (cholecalciferol) for Allergic rhinitis

Phase II/III trial of Colecalciferol (cholecalciferol) for Allergic rhinitis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Allergic rhinitis
Trial Stage
Phase II/III
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
28-06-2024
First CTIS Authorization Date
09-07-2024

Trial design

Randomised, alutard sq timotej, 10 000 sq-e/ml, injektionsvätska, suspension (comparator; route: subcutaneous injection; product maxdailydoseamount 1000 squ/ml indicated). | grazax 75 000 sq-t frystorkad sublingual tablett (comparator; route: sublingual; product maxdailydoseamount 75000 squ indicated). | natriumklorid braun 9 mg/ml spädningsvätska för parenteral användning (placebo; route: intramuscular or intravenous).-controlled Phase II/III trial across 4 sites in Sweden.

Randomised
Yes
Comparator
Alutard SQ Timotej, 10 000 SQ-E/ml, injektionsvätska, suspension (comparator; route: subcutaneous injection; product maxDailyDoseAmount 1000 SQU/ml indicated). | GRAZAX 75 000 SQ-T frystorkad sublingual tablett (comparator; route: sublingual; product maxDailyDoseAmount 75000 SQU indicated). | Natriumklorid Braun 9 mg/ml spädningsvätska för parenteral användning (placebo; route: intramuscular or intravenous).
Target Sample Size
360

Eligibility

Recruits 360 No vulnerable population selected (isVulnerablePopulationSelected=false). Participants are adults (age 18–60) and must provide written informed consent as per inclusion criteria ("forskningspersonen har gett sitt skriftliga samtycke till att delta i studien"). No assent or child-consent procedures are specified..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). Participants are adults (age 18–60) and must provide written informed consent as per inclusion criteria ("forskningspersonen har gett sitt skriftliga samtycke till att delta i studien"). No assent or child-consent procedures are specified.

Inclusion criteria

  • {"criterion_text":"- ålder:18–60 år vid screening\n- verifierad gräsallergi med måttliga till svåra symptom enligt RTSS (Rhinoconjunctivitis Total Symptom Score >8)\n- forskningspersonen har gett sitt skriftliga samtycke till att delta i studien"}

Exclusion criteria

  • {"criterion_text":"- näspolypos eller kronisk rinosinuit\n- tidigare behandling med SCIT/SLIT\n- BMI>35 (p g a potentiell svårighet att se lymfkörtlarna med ultraljud)\n- symptomgivande allergi mot kvalster\n- sensibilisering mot pälsdjur om exponering ej kan undvikas\n- 25(OH)D >75nmol/L eller <25nmol/L\n- överdrivet användande av solarium eller vitD tillskott\n- mental oförmåga att förstå och följa studiens protokoll\n- psykisk sjukdom med funktionshinder som påverkar förmåga att delta i studien\n- annan sjukdom som enligt läkaren antingen kan utsätta patienten för risk på grund av deltagande i studien eller kan påverka studiens resultat eller patientens förmåga att delta i studien\n- känd eller misstänkt allergi mot studieprodukten"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Det primära utfallsmåttet är CSMS (Combined Symptom Medication Score) under gräspollensäsong efter behandlingen. CSMS jämförs med baslinjens CSMS samt med CSMS i placebogruppen. Baslinjen definieras som pollensäsong före behandling.","definition_or_measurement_approach":"CSMS (Combined Symptom Medication Score) measured during the grass pollen season after treatment; compared to baseline (pollen season before treatment) and to the placebo group."}

Secondary endpoints

  • {"endpoint_text":"- CSMS under gräspollensäsongstopp, före och efter behandling","definition_or_measurement_approach":"CSMS measured at peak grass pollen season, before and after treatment."}
  • {"endpoint_text":"- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) före och efter behandling","definition_or_measurement_approach":"RQLQ scores assessed before and after treatment."}
  • {"endpoint_text":"- NTS score före och efter behandling","definition_or_measurement_approach":"NTS (nasal symptom) score assessed before and after treatment."}
  • {"endpoint_text":"- VAS (visual analogue scale) före och efter behandling","definition_or_measurement_approach":"Visual Analogue Scale scores assessed before and after treatment."}
  • {"endpoint_text":"- Analyser av nässköljning med flödescytometri, PCR och ELISA m.m för kvantifiering av immunceller och Th1 / Th2-cytokiner före och efter behandling","definition_or_measurement_approach":"Analyses of nasal lavage samples using flow cytometry, PCR and ELISA to quantify immune cells and Th1/Th2 cytokines before and after treatment."}
  • {"endpoint_text":"- Nivåer av IgE, IgG, IgA och Th1 / Th2 cytokiner i serum före och efter behandlingen.","definition_or_measurement_approach":"Serum levels of IgE, IgG, IgA and Th1/Th2 cytokines measured before and after treatment."}

Recruitment

Planned Sample Size
360
Recruitment Window Months
87
Consent Approach
Written informed consent is required from participants (inclusion criterion: "forskningspersonen har gett sitt skriftliga samtycke till att delta i studien"). Subject information and informed consent form documents are listed (FP_info_SLIT and FP-info_ILIT). Participants are adults (18–60); no assent procedures described.

Geography

Total Number Of Sites
4
Total Number Of Participants
360

Sweden

Earliest CTIS Part Ii Submission Date
11-06-2024
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
28
Number Of Sites
4
Number Of Participants
360

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Allergimottagningen
Contact Person Name
Ulla Westin
Contact Person Email
ulla.westin@med.lu.se
Site Name
Sodra Alvsborg Hospital Vastra Gotalandsregionen
Department Name
Lungmottagningen
Contact Person Name
Dan Weinfeld
Contact Person Email
dan.weinfeld@vgregion.se
Site Name
Region Oerebro Laen
Department Name
Öron, näsa, hals mottagningen
Contact Person Name
Amanj Saber
Contact Person Email
amanj.saber@oru.se
Site Name
Karolinska University Hospital
Department Name
ÖHN
Contact Person Name
Lars-Olaf Cardell
Contact Person Email
lars-olaf.cardell@ki.se

Sponsor

Primary sponsor

Full Name
Karolinska University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Co-sponsors

  • Karolinska Institutet

Investigational products

Investigational Product Name
COLECALCIFEROL
Active Substance
Colecalciferol (cholecalciferol)
Modality
Small molecule
Routes Of Administration
Intramuscular
Route
Intramuscular
Maximum Dose
100000 IU/ml
Investigational Product Name
Alutard SQ Timotej, 10 000 SQ-E/ml, injektionsvätska, suspension
Active Substance
Phleum pratense (timothy grass)
Modality
Other
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Authorisation Status
Marketing authorisation number 22167 (SE)
Maximum Dose
1000 SQU/ml
Investigational Product Name
GRAZAX 75 000 SQ-T frystorkad sublingual tablett
Active Substance
Phleum pratense (timothy grass)
Modality
Other
Routes Of Administration
Sublingual
Route
Sublingual
Authorisation Status
Marketing authorisation number 21278 (SE)
Maximum Dose
75000 SQU
Investigational Product Name
Natriumklorid Braun 9 mg/ml spädningsvätska för parenteral användning
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
Intramuscular or intravenous
Route
Intramuscular or intravenous
Authorisation Status
Marketing authorisation number 11123 (SE)
Maximum Dose
9 mg/ml
Combination Treatment
Yes

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