2023-508013-16-00
Completed
Phase 3
A prospective, randomized, double-blind placebo-controlled multicentre study with mannan-conjugated birch pollen allergoids administered subcutaneously to adolescent and adult patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
CCDRD Cooperative Clinical Drug Research and Development AG, Inmunotek S.L., ClinCompetence Cologne GmbH51 sites in 2 countries600 target enrollmentStarted: February 14, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Inmunotek S.L., ClinCompetence Cologne GmbH
- Enrollment
- 600
- Locations
- 51
- Primary Endpoint
- The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2024 between the placebo and the active treatment group.
Overview
Brief Summary
The primary objective of this trial is to assess the clinical impact of T502 treatment administered subcutaneously to participants with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Observational Phase
- Masking
- Double (Subject, Analyst, Monitor, Carer, Investigator)
Eligibility Criteria
- Ages
- 0 years to 64 years (18-64 Years, 0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Signed and dated Informed Consent Form a. by a legally competent participant, b. For adolescents: self-completed (signed and dated) participant informed consent to participate in the trial and signed and dated Informed Consent Form by both parents/legal guardian(s)
- •Patients aged from 12 to 64 years (at least 10% of the population should be 12-17 years of age (valid for Poland) OR patients aged from 18-64 years (valid for Germany)
- •Being in good physical and mental health
- •Confirmed normal renal and liver function, including non-clinically significant deviations outside the reference ranges (< grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials [FDA 2007] at screening visit. Participants with laboratory values > grade 1 will require retesting. Upon normalization of the outof- range value(s), the participant will be eligible)
- •Females with childbearing potential (a woman is considered of childbearing potential [WOCBP] according to the CTFG, if she is i.e., fertile, following menarche and until becoming postmenopausal unless becoming permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must be willing to use a highly effective method of contraception: a. Oral, intravaginal or transdermal hormonal medical drugs or -devices containing oestrogen/progesterone combinations. b. Oral, injectable or implantable hormonal medical drugs or -devices containing progesterone-only. c. Intrauterine device (IUD); d. Intrauterine hormone-releasing system (IUS) e. Bilateral tubal occlusion f. Vasectomized partner (provided that partner is the sole sexual partner of the WOCB trial participant and that the vasectomized partner has received medical assessment of the surgical success) g. Sexual abstinence (Defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant). or females unable to bear children (i.e., pre-menarche, tubal ligation, hysterectomy, or post-menopausal (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.)
- •Female participants with childbearing potential must have a negative pregnancy test in serum at screening
- •Having the diagnosis of birch pollen allergy based on all the following criteria: a. A medical history of moderate to severe allergic rhinitis or rhinoconjunctivitis for birch pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA), b. A positive skin prick test (SPT - wheal diameter ≥3 mm) to birch pollen allergens, positive control (histamine) wheal ≥3 mm, negative control (NaCl) wheal <2 mm, c. Specific IgE against birch pollen allergens (minimum CAP class 3 or higher, ≥3.5 kU/L, in case that the IgE CAP-class is =2, the participant can be included, when a previous lab report [not older than 2 years and measurement outside the birch pollen season] states that the subject has CAP class 3 or higher), d. Being treated with anti-allergic medication for at least 2 seasons prior to enrolment
- •For asthmatic participants: confirmed diagnosis of controlled asthma during the treatment period according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2022)
- •FEV1 ≥80% of the participant’s reference value or Peak Expiratory Flow (PEF) ≥80% of the participants´ individual optimal value (for asthmatic participants only)
Exclusion Criteria
- •Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
- •Participants who have a suspected or symptoms of a SARS-COV-2 infection, who have had contact with a confirmed case of COVID-19 up to 3 days prior to the screening visit
- •History of hypersensitivity to the excipients of the investigational product or placebo
- •Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2022) during the treatment period
- •Chronic asthma or emphysema, particularly with a Forced Expiratory Volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participants’ individual optimal value
- •History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
- •History of significant renal disease or chronic hepatic disease
- •Malignant active disease (ongoing or within the five past years)
- •Severe autoimmune disease
- •Immune defects including immunosuppression, immunopathies
Outcomes
Primary Outcomes
The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2024 between the placebo and the active treatment group.
The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2024 between the placebo and the active treatment group.
Secondary Outcomes
No secondary outcomes reported
Investigators
Medical Director
Scientific
Inmunotek S.L.
Study Sites (51)
Loading locations...
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