Study to Assess the Safety and Effectiveness of Beltaven®... | NCT07309822

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

May 2031Estimated

Completion Date

Dec 2031Estimated

First Submitted Date

Dec 16, 2025

First Submission Date that Met QC Criteria

Dec 16, 2025

First Posted Date

Dec 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltaven® With Apis mellifera, Polistes dominula or Vespula spp. allergic patients

Detailed Description

This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltaven in Apis mellifera, Polistes dominula or Vespula spp (children and adults) in routine medical care.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen	Proportion of patients who show tolerance (absence of systemic reaction) to the controlled sting challenge test conducted during the challenge visit, or to an accidental sting in a rural setting during the continuation treatment period	9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 14 years or older at the time of study inclusion.
Written informed consent, duly signed and dated by the patient or by the legal representative in the case of minors.
Assent form duly signed and dated by the minor, when applicable.
Patients with allergy to Apis mellifera, Vespula spp., or Polistes dominula who have experienced a systemic reaction following a hymenoptera sting, either with involvement of multiple organs or exclusively cutaneous.
Positive intradermal test (mean wheal diameter ≥ 5 mm) with Beltaven® diagnostic (allergenic extract of Apis mellifera, Vespula spp., or Polistes dominula).
Positive specific IgE test from class 1 onwards (≥ 0.35 kUA/L).
Patients willing to receive immunotherapy with Beltaven®.

Exclusion Criteria:

Patients with severe cardiovascular diseases, active malignant neoplasms or malignancies in remission within the last 5 years, non-stabilized systemic or organ-specific autoimmune diseases, severe mental disorders, or other relevant chronic diseases that may interfere with the study results.
Patients with known allergy to any of the vaccine excipients.
Pregnant patients, patients planning to become pregnant during the study period, or breastfeeding patients.
Patients who have received hymenoptera immunotherapy within the 5 years prior to inclusion or during the study.
Patients who are to receive immunotherapy with another specific allergen different from the investigational treatment during the study period.
Patients with confirmed sensitization to two or more hymenoptera species as demonstrated by CAP inhibition testing.
Patients with thrombocytopenic purpura and vasculitis, rhabdomyolysis, or renal failure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients older than 14 years with allergy to hymenoptera venom (Apis mellifera, Vespula spp., or Polistes dominula)

Sampling Method

Non-Probability Sample